UNTANGLING THE WEB OF ANTIRETROVIRAL PRICE REDUCTIONS
utw.msfaccess.org

12th EDITIONJANUARY 2010

New!
We're delighted to announce the launch of an online version of Untangling the
Web of Antiretroviral Price Reductions, Médecins Sans Frontières' guide to theprices of AIDS medicines, now in its 12th edition.
The online version reproduces the features of Untangling the Web - an analysisof the access to antiretrovirals environment, individual drug profile pages withprices quoted by companies, charts representing the evolution in price inprevious years, and a spotlight on access issues including a look at patents
and paediatrics - in a clear, user-friendly and free-flowing design.

http://utw.msfaccess.org

Disclaimer: "Untangling the Web of Price Reductions" is a pricing guide and cannot
be regarded as a company price list. It is crucial that any purchaser verify prices
and availability as well as quality status directly with the supplier before
procurement. Médecins Sans Frontières has made every effort to ensure theaccuracy of prices and other information presented in this report, but MSF makes
no representations or warranties, either expressed or implied, as to their accuracy,completeness or fitness for a particular purpose. Inclusion of a product in thisdocument does not indicate MSF purchases or uses the product. Information on
patent status of the products mentioned in this guide is indicative only and not
exhaustive, and should be verified with relevant national patent offices when used
for other than reasons of general information.

2 • Médecins Sans Frontières • January 2010 • Untangling the Web of ARV Price Reductions • Please check utw.msfaccess.org

Table of Contents

Drug Profiles
Single Antiretrovirals

15
18
19

Background: The Access to ARVs Environment
Quality issues
Methodology

20
How to read the drug profiles
Entry Inhibitors
21
Maraviroc (MVC)
Fusion Inhibitors
22
Enfuvirtide
Integrase Inhibitors
23
Raltegravir (RAL)
Non-Nucleoside Reverse Transcriptase Inhibitors (NNRTI)
24
Efavirenz (EFV)
26
Etravirine
27
Nevirapine (NVP)
Nucleoside & Nucleotide Reverse Transcriptase Inhibitors (NRTI & NtRTI)
29
Abacavir (ABC)31
Didanosine (ddI)
33
Emtricitabine (FTC)34
Lamivudine (3TC)
36
Stavudine (d4T)38
Tenofovir Disoproxil Fumarate (TDF)
40
Zidovudine (AZT or ZDV)
Protease Inhibitors (PI)41
Atazanavir (ATV)
42
Darunavir (DRV)43
Fosamprenavir (FPV)
44
Indinavir (IDV)
45
Lopinavir/Ritonavir (LPV/r)
47
Nelfinavir (NFV)
49
Ritonavir (RTV or r)
51
Saquinavir (SQV)
53
Tipranavir (TPV)
Médecins Sans Frontières • January 2010 • Untangling the Web of ARV Price Reductions • Please check utw.msfaccess.org • 3

Fixed-Dose Combinations and Co-Packs

54
55
57
59
60
62
64
66
68
70
72
74

Abacavir/Lamivudine (ABC/3TC)
Lamivudine/Stavudine (3TC/d4T)
Lamivudine/Stavudine/Nevirapine (3TC/d4T/NVP)
Lamivudine/Stavudine (3TC/d4T) + Efavirenz (EFV)
Tenofovir Disoproxil Fumarate/Emtricitabine (TDF/FTC)
Tenofovir Disoproxil Fumarate/Emtricitabine/Efavirenz (TDF/FTC/EFV)
Tenofovir Disoproxil Fumarate/Lamivudine (TDF/3TC)
Tenofovir Disoproxil Fumarate/Lamivudine/Efavirenz (TDF/3TC/EFV)
Zidovudine/Lamivudine (AZT/3TC)
Zidovudine/Lamivudine/Abacavir (AZT/3TC/ABC)
Zidovudine/Lamivudine/Nevirapine (AZT/3TC/NVP)
Zidovudine/Lamivudine (AZT/3TC) + Efavirenz (EFV)

Annexes

75
79
82
82
82
82
82
83
83
83
85
86
87

Annex 1: Summary of Prices in US$ quoted by companies for eligible developing countries
Annex 2: Conditions of Offer by Company
Annex 3: Least-Developed Countries (LDCs)
Annex 4: Human Development Index (HDI)
Annex 5: Sub-Saharan countries
Annex 6: World Bank classification of economies
Annex 7: Bristol-Myers Squibb eligible countries
Annex 8: Abbott eligible countries
Annex 9: Gilead eligible countries
Annex 10: Merck eligible countries
Annex 11: Suggested resources for further information
Annex 12: Company contacts
Annex 13: The Clinton Foundation antiretroviral price list

90
97

References
Abbreviations

4 • Médecins Sans Frontières • January 2010 • Untangling the Web of ARV Price Reductions • Please check utw.msfaccess.org

Ten years ago, on the heels of
Médecins Sans Frontières (MSF) being
awarded the Nobel Peace Prize - andlargely in response to the inequalities
surrounding access to AIDS treatment
between rich and poor countries –MSF launched the Campaign for
Access to Essential Medicines. Itssole purpose has been to push foraccess to, and the development oflife-saving and life-prolonging
medicines diagnostics and vaccines
for patients in MSF programmes andbeyond. Untangling the Web of
Antiretroviral Price Reductions, MSF'sguide to the prices of AIDS medicines,
is now in its 12th edition, andavailable for the first time as an
online resource at utw.msfaccess.org.

Introduction
HIV/AIDS is a lifelong disease, andalthough there is no cure, treatment
with antiretroviral drugs (ARVs) prolongs
and improves the quality of life.
AIDS treatment in developing countries
began roughly a decade ago, normallyas small pilot projects and in the faceof widespread scepticism about its
feasibility in resource-poor settings.
MSF was one of the first organisations
to provide antiretroviral therapy (ART)in developing countries, starting withprojects in Thailand and South Africa
in 2000.

“It's a question of choice for governments. Will they give people
in developing countries just a few extra years of life, or the samechance for long-term survival as people with HIV/AIDS inrich countries?”
Dr. Tido von Schoen-Angerer,
Director of MSF's Campaign for Access to Essential Medicines
MSF now provides treatment to140,000 people in more than 30
countries and today a total of four
million people across the developingworld are on ART.1 While thisrepresents important progress, anapproximately further six million
people in immediate need of treatment
are a testament to the persistentemergency.2 With growing numbers ofpatients in developing countries
having been on treatment for five
years or longer, new challenges are
emerging to ensure their long-term
survival. In India alone nearly 240,000
people are accessing first-line ART
under the national AIDS treatment
programme.
Delivering ART to millions of people indeveloping countries was madepossible because treatment was
brought close to where people lived,
drug costs came down dramatically,
and treatment was simplified; several
medicines were combined into one pill(a fixed-dose combination, or FDC).
And in order to address the shortagesof medical staff in many countries,

tasks are being shifted in many places,
so that nurses or nurse aides canperform many of the duties previously
reserved for doctors.
However, about 60% of people in needof treatment today are not receiving it.
The number of people in need oftreatment will significantly increase withthe recent revision of WHO guidelines
which have recommended, in line withcurrent evidence, that treatment beinitiated earlier in a patient's diseaseprogression. Starting treatment earlier
will greatly reduce the risk oftuberculosis infections, among others.
Extending ARV treatment in developing
countries to all people in need, while
ensuring patients can survive with HIV
in the long term, will require much
more investment and political will. For
treatment to be most successful,patients need to be monitoredeffectively and have access to newer
and more potent drugs when they
inevitably develop resistance or side
effects to their medicines over time.
But most newer drugs are unaffordable

because they are protected by patents
and crucial monitoring tests are notadapted for use in resource-poor
settings.
Over the last decade, effective action
by public interest groups and People
Living with HIV/AIDS (PLHA) networks
has raised the alarm and billions ofdollars have been mobilised. However,
the international AIDS effort is at a
critical juncture, compromised further
by the response of world leaders to
the economic crisis: the two main
funding sources for HIV/AIDS indeveloping countries, the Global Fundand the U.S. President's Emergency
Plan for AIDS Relief (PEPFAR), will not
be able to support the treatment
scale-up at its current rate given
insufficient donor commitment. The
Global Fund is facing a significant
financing gap and PEPFAR's funding
levels are flat.
Given the unprecedented disease
burden represented by HIV and the
proportion of overall mortality caused
by AIDS in most affected countries including child and maternal deaths HIV/AIDS continues to be a global
emergency. An effective HIV/AIDS
response, in particular access totreatment, has a positive populationlevel impact on adult, infant andunder-five mortality.3

Médecins Sans Frontières • January 2010 • Untangling the Web of ARV Price Reductions • Please check utw.msfaccess.org • 5

Only three years after world leaders
met at the 2006 United Nations
General Assembly and committed touniversal access to HIV prevention,
treatment and care, political andfunding support is waning. The
number of people who will needtreatment by 2030 has been projected
to reach as many as 55 million.4 A
sustained response to HIV/AIDS
includes an obligation to put people
on treatment and to continue
treatment as medically required.

One of the most promisingdevelopments over the past year has
been the green light given by theinternational drug purchase facility

Challenges: Second-ClassAIDS Treatment

heart disease or diabetes, and patients
generally have access to an increasing
variety of treatment options once they
inevitably develop drug resistance.6
In contrast, people living with HIV/AIDS
in developing countries largely haveaccess to only one combination of
medicines that causes significant side
effects, with few or no alternatives forwhen their treatment fails. And the
youngest people living with AIDS
continue to be an afterthought paediatric treatment still lags behindthat for adults, as does thedevelopment of appropriate ARVs forchildren.

There is a growing disconnect between
the AIDS treatment available to people
in developed countries and to theircounterparts in developing countries.
In wealthy countries, AIDS now
resembles a chronic disease, much like

“The number of people needing HIV treatment will rise over the next
two decades and so will the cost of treatment. This is because better,more effective treatments have come on the market and should beoffered to patients, and also because, over time, more people will
move from first to second (and later) line regimens, which are more
expensive.”
The Treatment Timebomb -- Report of the Enquiry of the UK All Party
Parliamentary Group on AIDS56 • Médecins Sans Frontières • January 2010 • Untangling the Web of ARV Price Reductions • Please check utw.msfaccess.org

If people living with HIV/AIDS are to
be given the same prospects forsurvival whether they live indeveloping countries or in wealthy
countries, urgent action must be
undertaken to ensure access:■ to a less toxic first-line regimen;■ to second- and third-line treatment
options as patients develop resistance;■ better and timely detection oftreatment failure through increased
access to viral load testing; and■ to paediatric AIDS treatment
options, which must be prioritised
together with the prevention of
mother-to-child transmission of thevirus.
Photo © Jonathan Torgovnik

To ensure that funds stretch as far as
possible to meet the needs, policy
actions are needed to contain thecost of drugs, while ensuring quality
treatment for the long term.

UNITAID to establish the licensing
agency to run a patent pool for AIDS
medicines. A patent pool could help
overcome patent barriers and ensureswifter access to needed medicines ataffordable prices, while boosting thedevelopment of new fixed-dose
combinations and paediatricformulations. As it is a voluntarymechanism, the spotlight is now on
the pharmaceutical industry and otherpatent owners to participate andmake this groundbreaking mechanism
the lifesaver it is intended to be.

A) Move to a less-toxic and morerobust first-line regimen
The first line of defence to help slow
the pace at which patients need toswitch to newer, more expensive ARV
treatment regimens is a robust firstline drug combination with few side
effects. Today, the majority of people
on their first-line of ARVs in low andmiddle-income countries receive the
combination of lamivudine/stavudine/
nevirapine (3TC/d4T/NVP).7 Thanks togeneric competition, this regimen now
costs US$80 per patient per year (ppy)– 99% less than ten years ago. This
dramatic price drop was possible

because of competition among
multiple generic manufacturers incountries where these drugs were notpatented, such as Brazil, Thailand andIndia (see graph 1).
But despite the dramatic price drop
over the past decade, using thisstandard combination comes at a highmedical cost. The drug stavudine(d4T) causes serious side effects, someintolerable, such as peripheral
neuropathy. It can also cause lactic
acidosis, which in rare cases can leadto death. It also causes stigmatisation
because over long-term treatment,

patients develop facial wasting whichis easily recognisable.

movement in the prices of less-toxic
first-line combinations.

Stavudine is virtually no longer used in
wealthy countries (in 2006, fewer than
2% of patients in Switzerland, forexample were taking the drug).8
Patients in these countries are offeredbetter-tolerated alternatives, such as
tenofovir (TDF) or zidovudine (AZT).

The price of tenofovir has come down
significantly over the past year by overa third, to US$100 ppy for the lowest
generic price. This means that TDFbased combinations are now nearly
the same price as those containing
zidovudine (see graph 2). Genericcompetition is steadily helping theseprices to come down and prices canbe expected to fall further withincreased demand.

Until now, the significantly higher costsof these alternatives have largely
prevented this switch in many
developing countries. However, there
has been noteworthy downward

Design HIV drugs with developing country needs in mind
With 95% of people with HIV/AIDS
living in developing countries, it isurgent that research anddevelopment take into account theparticular needs of these
populations. Such considerations
must be systematically integrated
into the early stages of the drug
development process.
Over the last three years, there havebeen significant advances in HIV
medicine, which have led to anumber of new drugs from older
classes, as well as entirely new
therapeutic classes being approved
for use. The new drug classes havedifferent mechanisms of action totarget the HIV virus, providing people
living with HIV/AIDS with additional
treatment options.
However, since ARVs are developed
primarily for developed country
markets, data relevant to address the
specific needs of populations indeveloping countries, such as pregnant
women or people who also need totake drugs for tuberculosis due to coinfection, is not obtained in clinical
trials. A further example is the lack ofknowledge about the interactions
between antimalarials andantiretrovirals,12 even though 80% of

people living with HIV live in regions
where malaria is endemic.13

European Medicines Agency (EMEA)
followed suit in January 2007.15

Further, there is currently no safety andefficacy data for children for the new
drugs etravirine, maraviroc, or
raltegravir and still no data for
tenofovir. For other drugs there arelimited data: for efavirenz (no data forchildren under three years), atazanavirand darunavir (no data for children
under six years). This despite the factthat the U.S. Food and Drug
Administration (FDA) has included
incentives and obligations toencourage submission of data for
paediatric use since 199714 and the

The need for high-tech monitoring
can also affect the availability of
antiretrovirals. For instance, theentry inhibitor maraviroc requires
the HIV virus to have the chemokine
co-receptor 5 (CCR5) to be effective.
To identify whether a patient has
CCR5 requires a complicateddiagnostic test costing more than
US$ 1,900 – a factor making its use
impracticable and unaffordable indeveloping country contexts where
even simple laboratory monitoring israrely available.

Médecins Sans Frontières • January 2010 • Untangling the Web of ARV Price Reductions • Please check utw.msfaccess.org • 7

The impact of such a move on
treatment programme budgets isevident. At best the price of first-line
regimens almost doubles. For TDFbased regimen in some middle-income
countries unable to access genericproducts due to patent protection, theprice increases almost thirteen fold.
In their one-pill-once-a-day version,
generic triple FDCs containing
tenofovir are now available for
US$210 ppy, down 51% over the past
two years. Notably, the originatorcompany price for the FDC containing
tenofovir/emtricitabine/efavirenz(TDF/FTC/EFV) has not changed in the

Lowest Originator $10439
Lowest Originator $727

10000
Brazil $2767
Lowest Originator $621

8000

Lowest Originator $555
Lowest Originator $549

6000
Hetero $295

Lowest Originator $331

4000
Aurobindo $159

Hetero $281

Cipla $132

Hetero $87

Cipla $80

200o0
Jun 00 Sept 01 Jun 02 Dec 02 Jun 03

past two years and remains far
higher at US$ 613 ppy for low-income
countries. And in some 'middleincome' countries, where generics are
not available due to patents, theoriginator price for the FDC remains
exorbitant, at US$ 1,033 ppy.
Although better, less-toxic first-line
regimens are still at best nearly
double the price of the mostcommonly used first-line regimen, thelong-term benefits of patients being
able to tolerate and stay on their first
ARV combination longer can outweighthe costs. A study in South Africa

Dec 03 Apr 04

Jan 05

Jun 05

Jun 06

Jul 07

Jul 08

Dec 09Graph 2: The impact of changing regimens on the price of first-line ARV treatment.
Prices of First-line Regimens in 2009
Price (US$) per patient per year

In December 2009, WHO released newrecommendations for antiretroviraltherapy for HIV in adults andadolescents. These newrecommendations advise countries tophase out stavudine-based regimens
because of their long-term irreversible
side effects and in its place, develop aplan to move towards zidovudine- or
tenofovir-based first-line regimens.375

12000
Price (US$) per patient per year

Graph 1: Competition as a catalyst for
price reductions The fall in the price offirst-line combinations of stavudine(d4T), lamivudine (3TC), andnevirapine (NVP), since the first editionof Untangling the Web of Price
Reductions.

1200

1033

1000
800
600
400
200

151

169

188

210

268

0
LowestLowest generic Lowest generic Best CF pricegeneric price
price
price
TDF/3TC/EFV
AZT/3TC/NVP TDF/3TC+NVP AZT/3TC+EFV

8 • Médecins Sans Frontières • January 2010 • Untangling the Web of ARV Price Reductions • Please check utw.msfaccess.org

Lowest generic Originator price
pricefor LMIC
TDF/FTC/EFV
TDF/FTC/EFVB) Secure access to second- andthird-line regimens
Lifelong AIDS treatment requires
constant access to newer and morepotent drug regimens when patientsdevelop side effects or resistance totheir medicines over time. Although
resistance is an inevitable element oflong-term treatment, it can be delayedby using drug combinations with fewerside effects to facilitate adherence, andcan be limited by changing treatment
soon after viral suppression begins towane.
Demand for newer AIDS drugs is
growing fast. In one of MSF's longestrunning AIDS treatment programmes,
in Khayelitsha, South Africa, 16% of
patients on treatment for five years
needed to switch to a second-line
drug combination because of“Seeing a patient that you havebeen treating since 2003, now
failing on her second
combination, you feel, as anurse, you are a failure. We are
feeling like our hands are tied.”Mpumi Mantangana, MSF nurse in
Khayelitsha, South Africa

resistance. And 25% of those patients
who switched again developed
virological failure to their second-line
regimen a further two years later.11
MSF's Khayelitsha data provides awindow into the growing need foraccess to newer AIDS drug regimens
and improved laboratory tools acrossthe developing world in the coming
years. However, the cost of newer
regimens and laboratory tools remains
a major barrier to access.
New WHO guidelines on second-line
further simplify and prioritise thechoice of regimens. Second-line
regimens may, in the future, be as low
as US$ 425 ppy (see graph 3). This is
2.8 times more than the cheapest
WHO-recommended first-line regimen.
As some patients in developing
countries have already developed
resistance to their second-line regimen,
it is crucial to secure further treatment

Death at the doorstep: Thembisa's story
Photo © Global Health TV

showed that the increased cost ofproviding the lowest-priced generictenofovir-based regimen would beoffset with savings on the cost of
managing the side effects ofstavudine.10 And while shifting
treatment programmes to a new firstline regimen brings with it clear
logistical challenges on top of cost
concerns, it is critical that treatment
providers begin moving away fromstavudine as has been done forexample in Zambia, Lesotho, Guyana,and Botswana.

“I'm so worried now because I
don't know what is going tohappen to me,” says Thembisa
Mkhosana, a mother of two who
lives in Khayelitsha, South Africa.
Thembisa discovered she was
HIV-positive in 2001 and began
receiving ART through MSF's
clinic two years later. She
responded well to treatment and was able to return to work and take care ofher children.
But after showing signs of treatment failure because of drug resistance,
Thembisa was switched to a second set of ARVs. Again she developed
virological failure . Thembisa now needs a third set of ARVs to keep her alive
but those newer drugs are unaffordable. “If there's no such thing that canhelp me, I know that I'm going to die,” says Thembisa. “And then who isgoing to look after my children?”
Thembisa is but one of many patients who now need access to newer andmore potent, but unaffordable ARV regimens.
“What we are seeing in Khayelitsha is what we will soon see throughout
Africa if there is not a focused push for urgent change,” says Dr. Eric
Goemaere, Medical Coordinator for MSF in South Africa.

options essential to long-term survival.
The price of a potential third-line ARV
regimen, however, could cost at least
15 times the WHO-recommended firstline regimen because of patentbarriers, and at least 5.4 times what
the cheapest second-line regimen
costs.

The new recommendations for the firsttime call for the need for third-line
therapy. As many studies are ongoing,
drugs likely to have anti-HIV activity inthird-line regimens are boosted
darunavir, etravirine and raltegravir.375

Médecins Sans Frontières • January 2010 • Untangling the Web of ARV Price Reductions • Please check utw.msfaccess.org • 9unaffordable price will mean theyalmost certainly once again face death.
There is no room for complacency
about these prices. Unlike with thefirst generation of AIDS drugs, patents
in key producing countries such as
India prevent the production of much
more affordable generic versions:many of the newer ARVs will bepatentable in India, and several suchPrice comparisons of first-lines, second-lines and possible third-lines
First-line

Second-line

Possible third-line

as raltegravir, maraviroc or etravirine
already are. The lack of competition
among generic manufacturers meansthat prices cannot be expected tocome down the way they did for the
first generation of ARVs.
It is imperative that governments
undertake measures to ensure thatpeople in need of newer and morepotent ARVs are not denied accessbecause of patent barriers. The
UNITAID patent pool for antiretrovirals
is an important additional mechanism
to ensure future availability ofaffordable essential medicines.

2291+?
2500

C) Put an end to the neglect ofchildren living with HIV/AIDS

2000
1500
1000
500
0

151

169

Lowest genericprice
AZT/3TC/NVP

Lowest genericprice
TDF/3TC+NVP

425

470

Best CF price
TDF/3TC+ATV+rBest CF price
AZT/3TC+ATV+r

210
Best CF price
TDF/3TC/EFV

RAL+DVR+r+?

Graph 3: The treatment timebomb: the impact of switching to second- and thirdline regimens on the price of ARV treatment. Changing a patient's regimen
because of side effects or the emergence of resistance from first-line regimens tosecond-line regimens recommended by WHO involves a considerable price hike.
For third-line regimens, many of the newer antiretrovirals will be patentable inIndia, and several such as raltegravir already are. Treatment providers are once
again faced with the prospect of drugs being priced out of reach.

Photo © Brendan Bannon

For the first time a price for raltegravir
has been announced for low-income
countries at US$ 1,113 ppy. No pricing
for developing countries has beenannounced for etravirine. As raltegravir
and boosted darunavir would be only
two of three components, it isestimated that a third-line regimen
could exceed US$ 2,291 ppy. For mostpeople who are failing on theirsecond-line combination already, thisWhile there has been important
progress in scaling-up paediatric AIDS
treatment over the past year, children
continue to be an afterthought when it
comes to treatment and developing
appropriate and adapted medicines tomeet their needs. Furthermore, much
more effort needs to be placed on
preventing mother-to-childtransmission (PMTCT) of the virus inorder to eliminate these entirely
avoidable infections in the first place.
The vast majority of children with
HIV/AIDS are infected throughtransmission from the mother during

10 • Médecins Sans Frontières • January 2010 • Untangling the Web of ARV Price Reductions • Please check utw.msfaccess.org

pregnancy, childbirth or breastfeeding.
PMTCT has been so successful in
wealthy countries that nearly nochildren are newly infected with AIDS.
But in developing countries, nearly
370,000 new child infections occurredin 2007 - a testament to the failure toeffectively implement simplified andefficient PMTCT strategies that could
dramatically reduce the number ofchild infections. Such strategies
include the provision of triple ART to
all HIV-positive pregnant women andintroducing ways to protect the childthroughout the breastfeeding period.17
This would lessen the need for
paediatric treatment, as has been thecase in wealthy countries.
Because there are so few children with
HIV/AIDS in wealthy countries, there isvery limited investment by thepharmaceutical industry into

developing appropriate and adapted
paediatric ARVs. There are several
available paediatric fixed-dose
combination tablets that come indoses for various child sizes and theprice of the paediatric FDC
d4T/3TC/NVP is finally lower than thatfor adults, at US$61 ppy. But the factthat the first WHO prequalified
paediatric ARV FDC became available
only in 2006, while the adultequivalent has been available since2001, reflects the way in whichchildren with AIDS lag behind.
Furthermore, of the 22 ARVs approvedby the U.S. FDA for adults, six are notapproved for use in children and seven
do not have any paediatricformulations.18 The majority of these
paediatric formulations continue to be
ill-adapted for use in resource-poor
settings. This means they either comein powder or syrup form, with someformulations having the drawbacks ofbitter taste, and needing to be mixed
with clean water or requiring
refrigeration, both of which can bedifficult to come by in many
developing country contexts.
In April 2008, WHO revised its
paediatric ARV treatment guidelines,
recommending the use of the proteaseinhibitor LPV/r for infants that havebeen exposed to nevirapine directly or
through their mothers. However, thisjustified recommendation means taking
a regimen including LPV/r syrup, which
is nearly 70% more expensive than aliquid nevirapine-based regimen andalso requires refrigeration. At the sametime, there is no alternative regimen
once the child fails this regimen. Thereis thus an urgent need for thedevelopment of child-friendly doses ofheat-stable protease inhibitors for the
youngest patients and urgent dosing
studies for the newer more potent
drugs need to be conducted.

Overcoming Challenges:
Staving off the Second Waveof the Access Crisis
Unaffordable, again…
Fierce competition among multiple
generic pharmaceuticalmanufacturers in countries such as
India and Brazil, where medicines
were not patented, is what brought
the cost of AIDS treatment down by
99% over the past decade, from
US$10,000 to US$80 ppy today.
India has thus been called the'pharmacy of the developing world,'
and, for example, MSF sources morethan 80% of the ARVs used in its
projects from India.

Develop simple diagnostic and monitoring tools for adults
and children
It is vitally important to be able to detect when a patient is no longer
responding to ART. Switching someone to a newer drug combination toolate or too soon can compromise the treatment's effectiveness.
A technology used to detect the level of the AIDS virus in patients' blood- called 'viral load' testing - is the gold standard. However, it requires
access to laboratories with sophisticated equipment, trained staff and thetransport of blood samples, all of which can be complicated or even
impossible in remote settings of poor countries.
There is an urgent need for simple and easy-to-use monitoring tests thatcan be used on the spot, overcoming these practical barriers. Without
access to such tests, many patients are being switched too early or too
late, only when they appear to be getting sick again once the virus hastaken hold anew.
Furthermore, HIV/AIDS diagnosis in infants is extremely difficult. In babies
under 18 months it can only be conducted with the use of a complex
DNA-based diagnostic test that is expensive to conduct, also requiring
trained personnel and access to sophisticated laboratory equipment. Only
15% of children born to mothers living with HIV in low and middle income
countries were tested for HIV within the first two months of life.16 There isa desperate need to develop a simple diagnostic test that can be used todetect the virus in younger infants on the spot, so that treatment can beinitiated as early as necessary. Early infant diagnosis is key because
without treatment, half the children will die before the age of two.
Until new tools exist, however, it is urgent for donors and treatment
providers to ensure that the existing diagnostic technologies are
implemented as widely as possible.

Médecins Sans Frontières • January 2010 • Untangling the Web of ARV Price Reductions • Please check utw.msfaccess.org • 11

A lack of patents in India
additionally fostered the productionof fixed-dose combination (FDC) pills- crucial to the simplification oftreatment that has fostered global
scale-up - because patents on theindividual compounds did not standin the way of combining the drugs.

such as compulsory licensing. Thereis an additional way - theparticipation of pharmaceuticalcompanies - originator and generic in new mechanisms to boost access.
Ensuring newer medicines are madeaffordable for people in developing
countries thus depends on:

Across the globe, increased productpatenting in developing countries isnow systematically ensuring that
more affordable generic versions of
medicines cannot be produced.
Under the World Trade
Organization's TRIPS Agreement(Trade-Related Aspects of Intellectual
Property Rights) and the 2001 Doha
Declaration on TRIPS and Public
Health, least-developed countries(LDCs) are not required to grant or
enforce patents on pharmaceuticals
until 2016. But international trade
rules now require the patenting of
medicines in key producing
countries like India and Brazil,
essentially eliminating the kind ofgeneric competition for the futurethat brought prices down in thepast.

■ a country's right to design proaccess patent laws;

Tomorrow's battle for access toaffordable ARVs will need to befought in a different way. It will
require routine use of public healthsafeguards in patent laws and offlexibilities in the TRIPS Agreement,

be able to obtain patents in India for
medicines that are not actual
inventions, such as combinations orslightly modified formulations ofexisting medicines. Such patentapplications are designed to delay
generic competition that could lead tolower prices.

India’s pro-access patent law
Not all patent applications are valid.

■ a country's right, when essential
medicines are patented andunaffordable, to issue compulsory
licenses to ensure access;Many of the applications do not claim real 'inventions' and therefore should
not deserve a patent. Many patent applications are for a new use of an olddrug, or simply for derivatives of old drugs or combinations of old drugs. The
Indian Patents Act, if rigorously interpreted, provides under Section 3(d)several grounds for rejecting a patent application, for instance if the patentclaimed is only a new form of a known pharmaceutical substance.

■ pharmaceutical companies
participating in the new HIV medicines
patent pool, the innovative mechanism
being established by UNITAID.

In 2006, the Indian patent office rejected Novartis' patent application for its
anti-cancer drug imatinib mesylate (Gleevec) on the grounds that theapplication claims a 'new form of a known substance' (Novartis' patentapplication was related to a particular crystal form of the salt of imatinib
mesylate).

A) Design flexible patent laws
The Doha Declaration stresses thatcountries have the right to design
patent laws that serve the interest of
public health.
When India amended its patent law in2005, it included several key
safeguards including a prohibition on
the patenting of insignificant or minor
improvements of known medicines.
This part of the India Patents Act isknown as Section 3(d). It means thatpharmaceutical companies should not

Novartis launched a legal proceedings challenging public health safeguards in
India's patent law in an attempt to strike down Section 3(d) of India's Patents
Act. This prompted MSF to launch the 'Drop the Case' petition in order toprotect the 'pharmacy of the developing world'.20 Novartis lost this case inAugust 2007 when the Madras High Court upheld the public health safeguard.
But Novartis is not letting go. Having lost the battle to strike down Section
3(d) of India's Patents Act almost two years ago, Novartis has launched fresh
legal proceedings in India to weaken this critical public health safeguard. The
Swiss multinational pharmacuetical company has filed a case before the IndianSupreme Court in what can be considered the second part of the Novartis
case.
This case, will determine is the manner in which Section 3(d) will be
implemented in India.

12 • Médecins Sans Frontières • January 2010 • Untangling the Web of ARV Price Reductions • Please check utw.msfaccess.org

“Reducing the costs of drugs
could enable savings that could
fund access to life-saving
treatment for an additional one
million people every year, even
without new resources.”
The Treatment Timebomb -- Report of
the Enquiry of the UK All Party
Parliamentary Group on AIDS19
For the first time, a country thusemphasised stricter patentability
criteria for pharmaceuticals andincluded provisions in its patent law
stipulating that patents should only
be granted on medicines that are
truly new and innovative.

Three down; many more to go: Opposing patents in India
in the name of access to affordable medicines
Since early 2006, the Indian Network of People Living with HIV/AIDS, the Delhi
Network of Positive People and the Positive Women's Network, together withother civil society groups in India and beyond have filed pre-grant oppositions
against the granting of patents on ARVs recommended by WHO for first- andsecond-line treatment. Many of these oppositions have been filed on the basisof the patent law's Section 3(d), which prevents 'evergreening' of known
medicines.
In 2006, GlaxoSmithKline withdrew its patent application for thelamivudine/zidovudine fixed-dose combination, after PLHA networks filed a pregrant opposition. In June 2008, India's patent office decided not to grant
Boehringer Ingelheim a patent for the nevirapine paediatric syrup after a pregrant opposition was filed. This set an important legal precedent and was
followed by two further crucial rejections in 2009 for patents on the key ARVs
tenofovir and darunavir which is one of the most expensive ARVs today.
While several patent applications relating to tenofovir, darunavir and other key
ARVs are still pending before the patent office, these rejections represent a
major victory for access, as generic manufacturers have taken up the productionof these medicines over time ensuring the lowest possible prices for thesedrugs. These decisions highlight the success and importance of Section 3(d)and opposition procedures in India's patent law to safeguard public health.
Other countries in need of access to affordable essential drugs should build
similar public health safeguards into their own patent law.

The law also allows any interested
party to oppose a patent before orafter it is granted ('pre-grant' and'post-grant oppositions'). Such
oppositions have been filed in India
by civil society and patient groups
from India and Brazil, with thepositive outcomes that several
patents on key ARVs were rejected by
the Indian patent offices on the
grounds that they lack inventive stepand fail to satisfy the requirements ofSection 3(d) of the patent law.

after 1995, which can be patented
under Indian law; several such as
etravirine, maraviroc, raltegravir
already are.

While Section 3(d) should help
safeguard against the granting offrivolous patents, there is still great
concern about newer drugs, invented

Generic production of these newer
ARVs will thus only start throughlicensing - be it voluntary or
compulsory.

B) Keep the door open forcompetition, despite patents
When drugs are patented, andpharmaceutical companies fail to fulfill
their obligation to make patented
medicines available and affordable topatients in developing countries, theonly way to bring prices down is either
through compulsory licensing or

voluntary licensing which allows genericproduction. In both cases, royalties arepaid to the patent holder.
Compulsory Licensing
Compulsory licensing is one of the
public health safeguards enshrined in
the TRIPS Agreement, which allows agovernment to override a patent bygiving another entity a licence toproduce the drug. Issuing acompulsory licence (CL) has proven tobring prices down dramatically by
opening up the market to competition
and thereby increasing access.
The case of the CL issued by Thailand
for lopinavir/ritonavir (LPV/r) in January
2007 clearly illustrates this. Over thecourse of one year, the price for LPV/rin middle-income countries decreased
by as much as 75%, from US$2,200
ppy to under US$900 in Thailand andUS$550 in countries in the Clinton
Foundation Consortium. Similarly, a CL
issued by Brazil for efavirenz in May
2007 brought the cost for the drug inBrazil down by almost 70%.
Even though issuing a CL is entirely inline with WTO rules, countries thattake the step typically face immense
direct and indirect retaliatory measuresand pressure from developed country
governments and the pharmaceuticalindustry. This can serve to discourage

Médecins Sans Frontières • January 2010 • Untangling the Web of ARV Price Reductions • Please check utw.msfaccess.org • 13

Photo © Zethu Mlobeli/MSF

patients to benefit from the lowest
prices possible.

other countries that are considering
issuing CLs. In a world in which
medicines are becoming increasingly
patented, CLs, including those forexport, will be a critical mechanism tohelp ensure that essential medicines areaffordable enough for people to accessthem and countries must feel supported
in their right to increase access toneeded medicines for their citizens.
Voluntary Licensing
When a drug is patented in a given
country, the patent holder may choose
to issue voluntary licences (VL) toother manufacturers, allowing them toproduce and export the drug. Whenthese VLs are offered to multiple
producers within a market or in several
countries and are not restrictive interms of where the licensees areallowed to export the drug, they canbe a useful way to increase access.
However, restrictive VLs can also serve
merely to extend the originatorcompany's control over a given
market, stipulating conditions such as
which source the active ingredientmust be purchased from, as well as towhich countries the drugs can beexported. Such restrictive VLs
ultimately do not lead to theunhindered competition that allows

As an example, U.S. pharmaceuticalcompany Gilead Sciences offered
voluntary licence agreements for the
production of tenofovir to any
interested generic manufacturer inIndia with clauses such as these. The
VL agreements stipulate that thegeneric manufacturers must purchase
the active pharmaceutical ingredientfrom Gilead itself or from a Gilead
licensee, instead of from a cheapersource, and that the manufacturers
may not export the drug to several
middle-income countries, including
Brazil and China. This means thatwhile competition among multiple
manufacturers (licensees) within India
has been taking place, Gilead
maintains control over which countries
are able to benefit from these lower
prices, often keeping itself as the sole
supplier source in these countries.
Crucially, all this was established by
Gilead at a time when their patentapplication on tenofovir was still
awaiting a ruling from India's patentoffice. In 2006, Indian civil society
organisations had filed pre-grant
oppositions to the patent applications
on the grounds that the drug consistsof a previously-known substance andis therefore not patentable under
India's Patents Act.

14 • Médecins Sans Frontières • January 2010 • Untangling the Web of ARV Price Reductions • Please check utw.msfaccess.org

In September 2009, the Indian patentoffice subsequently declined to grant apatent for tenofovir disoproxil andtenofovir disoproxil fumarate and in
July, the Brazilian patent office declined
patent for TDF. Gilead is now pursing a
new tactic to maintain its patent on
TDF by filing divisional applications (atype of patent application whichcontains matter from a previously filed
application) in the Brazilian and Indian
patent offices.

C) Pool patents and take theplunge for affordable treatment
Company-led 'access' schemes have
proven to be minimally effective.
While most companies today do offer
discounts through tiered pricing,experience has shown that in theabsence of competitors, manufacturers
enjoying a monopolistic situation do
not reduce prices deeply enough tomake medicines affordable fordeveloping countries. Also, countries
that are classified as 'middle-income'such as Brazil, Thailand, China or
Colombia, are often left out of the
discount scheme altogether or are
offered only minimal discounts.
Primarily the threat of losing a patentor having a patent barrier removed iswhat makes companies respond andreduce prices.

Stop the deliberate confusion of quality generic medicines and counterfeit medicines
Over the past few years there havebeen concerted attempts to subject
developing countries to much stricter
enforcement of intellectual property
rules which go beyond theobligations required under the TRIPS
Agreement and threaten thecontinued supply of affordable
medicines to developing countries.
As part of this push, there areproposals to introduce newprocedures and laws against'counterfeiting' within free trade
agreements (FTAs) and in multiple
international fora such as the World
Customs Union, World Trade
Organization, World HealthOrganization and in the AntiCounterfeiting Trade Agreement,
which would hamper or prevent thetrade in affordable generic medicines
between developing countries.
Crucially, the use of the term'counterfeiting' differs according to
the context: in intellectual property
law, it refers to the protection ofcommercial trademarks, yet the way
in which it has been commonly
understood by many in publichealth, is as a reference to fake orfalsely-labelled medical products that

present a public health threat. This
confusion has been exploited and the
public health concerns about fake orfalsely-labelled medicines used as anargument to push for stricter
enforcement of intellectual property.
Not only do these measures fail toaddress the public health problems,
they actively interfere with andthreaten access to medicines.
The dangers of overbroad IP
protection are illustrated by the recent
use of European Union customs rules,
which are used to help enforce EU
patents and trademarks. These rules
have in fact prevented the timely
access to life-saving medicines.
Several shipments of generic
medicines - including AIDS drugs have been detained in transit throughEuropean countries based onallegations of IP infringement, eventhough they are not protected by IP
rights in the countries of export orimport. This has affected the supply of
essential medicines frommanufacturers in India to patients indeveloping countries in Africa andLatin America. The EU customs rules
should be amended to prevent thisoccurring again.

Another example is the Kenyan AntiCounterfeiting Act which passed in
December 2008, and which uses adefinition of counterfeiting so widethat it includes all products that are
copies of patented goods. This would
also cover quality-assured and legallyproduced generic medicines. The Act
thus has the potential to seriously
endanger access to generic medicines,
such as those used by MSF and othertreatment providers in Kenya. It is
critical that the Act be revised. Publichealth groups are seeking a judicial
review on the grounds that the newlegislation contravenes their 'right tolife' under the Kenyan Constitution.
In a worrying trend, there are attempts
to introduce similar legislation in
Uganda. Public health organisations
there are concerned that the country's
draft Counterfeit Goods Bill 2009 may
also threaten access to generic
medicines if passed in its present
form.
One major problem that is notaddressed by the use of theexcessively general term 'counterfeit',
and which MSF teams face in many
countries, is posed by substandard

drugs. These are drugs fromoriginator companies as well asfrom generic producers that do notmeet international standards for
quality. To address the problem of
sub-standard medicines, measures
should be undertaken including by
WHO to assist manufacturers in
improving their production
processes to ensure quality
standards are met, and to provide
long-term technical assistance tostrengthen national drug regulatory
authorities.
To date, though, the focus of the
response to these questions has
been placed on protecting
commercial interests, rather thanaddressing serious public healthissues. This has meant diverting
attention from what needs to be
done. It is important that the
WHO and other key public healthactors refocus the debate on the
public health issues in relation to
the availability, safety efficacy andquality of medicines, and that
proposals for greater protection ofcommercial interests that threaten
access to medicines are rejected.

Médecins Sans Frontières • January 2010 • Untangling the Web of ARV Price Reductions • Please check utw.msfaccess.org • 15

There is one way companies could act
to make a difference, however. Theinternational drug purchase facility
UNITAID has just created a 'patentpool' for AIDS medicines. If successful,
this mechanism will make it possible
to access needed medicines much
more quickly and at much more
affordable prices than today and leadto the development of much-needed
medicines adapted to patients' needs.
Instead of having patents act asbarriers, companies, researchers oruniversities license the patents on
their inventions to one entity: thepatent pool.
In this way, any company that wants
to use the inventions can get a licencefrom the pool, under pre-determined
licensing terms, in exchange forroyalties. It could then produce
generic versions of the patented
inventions and export them tocountries covered by the licence. The
licences should be valid for a wide
geographical area, which would meana sufficiently attractive, large market
for potential producers. This process
will encourage multiple producers tocome forward, resulting in competition
between producers and bringing drug
prices down.
The patent pool would help increase
access to ARVs in three key areas:
1. It would help foster competition
among multiple manufacturers,
bringing prices down for newer andmore potent medicines needed byincreasing numbers of patients;
2. It would help facilitate the creationof new and needed fixed-dose
combinations, where otherwise patentson the individual drug compounds
stand in the way; and3. It would help support thedevelopment of paediatric ARV
formulations and combinations, byeliminating patent barriers.

Médecins Sans Frontières is calling for all patents on the following
antiretrovirals (and combinations thereof) to be put in the UNITAID patentpool:lopinavir, ritonavir (Abbott Laboratories);
nevirapine, tipranavir (Boehringer Ingelheim);
didanosine, atazanavir (Bristol-Myers Squibb);
lamivudine, abacavir, fosamprenavir, S/GSK1349572 (GlaxoSmithKline);
tenofovir disoproxil fumarate, emtricitabine, GS-9350, elvitegravir (Gilead
Sciences);
efavirenz, raltegravir (Merck);
maraviroc (Pfizer);
SPI-452 (Sequoia Pharmaceuticals);darunavir, etravirine, rilpivirine (Johnson & Johnson/Tibotec Pharmaceuticals)

MSF has identified a list of medicines
whose patents should be included in
the pool, and a list of needed fixeddose combinations that it is hoped thepool will help deliver. However, thepool will be voluntary, so crucially, thesuccess of the patent pool now
depends on companies' willingness toinclude their patents in the pool.

In April 2009, Pfizer and GSK jointly announced the creation of ViiV, a new joint venture
focusing solely on the R&D and commercialisation of HIV medicines.

16 • Médecins Sans Frontières • January 2010 • Untangling the Web of ARV Price Reductions • Please check utw.msfaccess.org

Conclusion
Looking back upon the first decade of
AIDS treatment in developing countries
shows key successes. Four million
people on treatment are alive today,
many of whom would have diedwithout ARVs long ago. The case has
thus been proven that AIDS treatment
is entirely feasible in resource-limited
settings. However, with six out of ten
people in need of treatment still notreceiving it and with projections of up
to 50 million people in need oftreatment in roughly 20 years, it isclear that treatment scale up mustoccur at a faster pace.
At the same time, steps must be
undertaken to ensure that people indeveloping countries are receiving the
optimal monitoring and treatment that
supports their long-term survival,
comparable to their counterparts livingwith HIV/AIDS in wealthy countries.

This means securing access to needed
monitoring tools, while providing
patients both with a robust first-line
regimen that has few side effects, aswell as ensuring there are treatment
options for when patients show signsof virological failure and need toswitch to a second- or third-line
combination. Although prices forcertain key newer medicines havecome down significantly because ofcompetition among genericmanufacturers and increased demand,
overall prices for newer drugs remain
unaffordable for developing countries
and out of reach of national treatment
programmes.
Countries must be supported in theiruse of flexibilities in international trade
rules to help bring prices of newer
drugs down more systematically andspeedily, so that the growing numberof people in need of newer and morepotent drugs has immediate accessonce they require them. Pharmaceuticalcompanies must be urged toparticipate in the patent pool created
by UNITAID, so that needed
formulations can be made available todeveloping countries more swiftly andat much more affordable prices.
And it is critical that HIV/AIDS
continues to be treated as the
emergency it is. Funding levels must
be increased to take on the massive
task of providing sustained AIDS
treatment in developing countries.
The worrying trend of treatment
providers needing to scale back ART at
a time when they should be scaling up
must be countered with sustained andreaffirmed commitment by leaders anddonors to universal access to HIV/AIDS
treatment.

Médecins Sans Frontières • January 2010 • Untangling the Web of ARV Price Reductions • Please check utw.msfaccess.org • 17

Quality Issues
This report is a pricing guide, and assuch does not include detailed
information about the quality of the
products listed. However, quality isimportant and price should not be theonly factor determining procurement
decisions.
Readers and purchasers wishing toobtain more information about drug
quality are therefore encouraged toconsult the WHO list of Prequalified
Medicinal Products which contains the
products that "meet unified standardsof quality, safety and efficacy for
HIV/AIDS, malaria and tuberculosis
medicines."More commonly known as the WHO
prequalification list, the project was
initiated by the WHO and developed incollaboration with other United Nationsorganisations, principally for
procurement by UN agencies. The
project evaluates pharmaceuticalmanufacturers and products according
to WHO-recommended standards ofquality and compliance with Good
Manufacturing Practices.
WHO's Prequalification Programme is abenchmark for the identification ofquality essential medicines and has
significantly improved access to quality
medicines over the past years. A key

factor of success has been that
financial support to national
programmes has been dependent onpurchasing medicines respecting clear
quality assurance criteria. In this the
WHO Prequalification Programme
played an important role, providing
guidance to purchasers on the qualityof medicines and thereby creating a
positive market dynamic where
manufacturers strive to reach WHO
standards in order to comply withprocurement policies.
The Global Fund to Fight AIDS,
Tuberculosis and Malaria has recently
changed its quality assurance policy sothat Global Fund grant funds may only
be used to procure antiretrovirals, antituberculosis and anti-malarial finishedproducts that are either prequalified by
the WHO Prequalification Programme,
authorised for use by a Stringent Drug
Regulatory Authority (SRA), or
recommended for use by an Expert
Review Panel (ERP).
Unfortunately, the majority of donors
today do not have sufficient quality
assurance criteria, giving a wrong
signal to manufacturers by removing
the incentive to comply with WHO
norms and standards, and ultimately
endangering patients' health incountries where the regulatory systemremains weak. Donors and drug

purchasers should take heed from the
Global Fund's example and make surethat they implement an effective quality
assurance policy for medicines bought
on behalf of developing countries.
Quality of drugs in the data provided in
Untangling the Web
Manufacturers who have at least one
WHO prequalified antiretroviralformulation were invited to participate
in this publication.
But not all the products listed in thisreport have been prequalified by WHO
and only some of them are used by
MSF in its own projects. Products
included in the WHO List of Prequalified
Medicinal Products (as of December2009), including the ones approved byHealth Canada, EMEA through article
58, U.S. FDA or tentatively approved by
U.S. FDA, appear in bold in the tablesof drug prices. Please consult the WHO
website (http://mednet3.who.int/prequal/)
for the latest list of prequalified
products and for information on thestatus of dossier assessment.

18 • Médecins Sans Frontières • January 2010 • Untangling the Web of ARV Price Reductions • Please check utw.msfaccess.org

METHODOLOGY
Questionnaires were sent to bothoriginator and generic companies
manufacturing antiretrovirals (ARVs),
requesting information on prices fordeveloping countries, restrictions that
apply to each of the prices quoted(eligibility criteria), and any additional
specificity applicable to the quoted
prices. The data were collected up to
December 2009.
All originator companies marketing
ARVs were included in the survey. But
the list of generic producers is by nomeans exhaustive. Only genericcompanies that have at least one ARV
listed on the WHO prequalification liston the date of the initial request for
information were included in thispublication. The initial questionnaires
were sent in the middle of May 2009.
Only generic manufacturers who
provided prices for their products areincluded in this document. Aspen
Pharmacare was invited to contribute tothis publication, however the company
has chosen not to provide prices, andas such will not be included in thisdocument. Similarly, Hetero has chosen
not to provide information for thispublication.

Some important preliminary remarks on
the data presented in this report:■ The information on prices given inthis publication only relates to ARVs. It
does not include other costs linked toantiretroviral treatment, such as
diagnosis, monitoring or treatment ofopportunistic infections. For informationon the prices of these products, please
consult the most recent edition of theWorld Health Organization's publication,“Sources and prices of selected drugs
and diagnostics for people living with
HIV/AIDS.”■ The manufacturers provide the prices
listed in this publication. The prices
paid by the purchaser might be higher
because of add-ons (such as importtaxes and distribution mark-ups), or
may be lower after negotiations. The
document should not be viewed as amanufacturer's price list, andprocurement agents are advised tocontact manufacturers directly toconfirm prices.
■ Companies use different trade terms(known as incoterms).
These trade terms outline theresponsibilities of the manufacturer andpurchasers with regard to transport,international freight and insurance
costs. Further explanations of theseterms are included in the glossary.

Prices in the publication have not beenadjusted to incorporate the different
terms. The U.S. General Accountability
Office has recently demonstrated thatthese differences do not undermine
their essential comparability■ As the information on the WHO prequalification list is updated regularly,
the list should be consulted for up-todate information regarding quality.
http://apps.who.int/prequal/■ Originator and some genericcompanies have different eligibility
criteria for differential pricing forcountries and entities. The different
categories of prices are detailed in the
drug profiles. More detailed informationon the different eligibility criteria isprovided in the annexes.
■ The Clinton HIV/AIDS Initiativenegotiates prices for ARVs anddiagnostic tests with generic companies
on behalf of national AIDS programmes
included in their consortium. The
Clinton Foundation has reachedagreements with eight ARV
manufacturers to lower the prices ofover 40 different ARV formulations, bothpaediatric and adult. The current pricelist is included in Annex 13. This is an
example of pooled procurement andhow it can have an impact on pricereductions.
■ Information on patents is only
indicative and should be checked withnational authorities. It should in no way
form the basis of a procurement
decision.

Médecins Sans Frontières • January 2010 • Untangling the Web of ARV Price Reductions • Please check utw.msfaccess.org • 19

How to Read the Drug Profiles
General information
General information on the history of the product and relevant WHO guidance isprovided for each of the antiretrovirals (ARVs) included in this publication.15,16
Separate drug profiles are included for both single ARVs and fixed-dose
combinations (FDCs) containing two or three ARVs.
Table 1: Prices quoted by companies for eligible developing countries
All prices are quoted in United States Dollars (US$). Conversions were made on
the day the price information was received using the currency converter sitewww.oanda.com. Prices are rounded up to the third decimal for unit price and to
the nearest whole number for yearly price per patient.
The annual cost of treatment per patient year (ppy) has been calculated
according to the WHO dosing schedules, multiplying the unit price (one tablet,
capsule or ml) by the number of units required for the daily dose and by 365.
The price of the smallest unit is included in brackets. Where no WHO guidelines
exist for a product, the dosage used is the U.S. FDA approved dosage.
For paediatric treatments, prices are calculated for a 10kg child using
recommended dosing based on weight bands, as it appears in the WHO
treatment guidelines.16 This is an estimate, as the weight of a child increases
during any given year. When it was not possible to calculate the dose for a 10kg
child, only the unit price is indicated. For paediatric FDCs the dosages used forthe calculation is as recommended by the Paediatric Antiretroviral Working Group
at WHO.17
Tiered prices – categories 1 and 2
When originator companies apply discounted prices on ARVs, each has different
eligibility criteria. This means that a country that is eligible for a price discountfrom one company may be excluded from the list of eligible countries by anothercompany. In this document, the term 'first category' or 'category 1' is used todescribe those countries that are eligible for the most discounted price offered
by a company. The term 'second category' or 'category 2' is used to describe
countries that are not eligible for the lowest prices reserved for category 1
countries, but are nevertheless offered a discount by companies - crucially, this

discount is usually considerably smaller than the discount offered to category 1
countries.
To know whether a country is eligible for a discounted price offered by agiven company, or in other words to find out which category a given country
is placed in by different companies, please refer to the annexes.
The WHO List of Prequalified Medicinal Products is a list of manufacturers andsuppliers who meet unified standards of quality, safety and efficacy for HIV/AIDS,
malaria and tuberculosis medicines. Products included in the WHO List ofPrequalified Medicinal Products for Antiretrovirals (as of December 2009) are in
BOLD in the tables of drug prices.
Readers and purchasers wishing to obtain more information about the quality of
ARVs are encouraged to consult the WHO Prequalification Program website as thislist is updated regularly (http://apps.who.int/prequal/).
The Clinton Foundation's HIV/AIDS Initiative negotiates with several manufacturers
for reduced prices for over 40 different ARV formulations for countries in theirpooled procurement consortium. Manufacturers who have a product included in
the most recent price announcement are indicated by a (CF) in the header of thetable.
Chart 1: Evolution of the lowest price quoted by companies for eligible countries
since 2001
This chart shows the price evolution over time, for both originator and genericproducts, as quoted to MSF for the purpose of this document since 2001.
If a WHO prequalified generic product is available, the lowest price quoted isshown in the graph. If no generic product is WHO prequalified, the lowest
possible price quoted is considered in the graph.
Spotlight on access issues
The most salient issues related to access to each product is summarised here.
The focus is on the availability of products, their affordability and theiradaptability for the developing world. A special comment has been included whenappropriate with regard to paediatrics.

20 • Médecins Sans Frontières • January 2010 • Untangling the Web of ARV Price Reductions • Please check utw.msfaccess.org

MARAVIROC (MVC)
General information• Therapeutic class: chemokine coreceptor 5 (CCR5) antagonist (entry
inhibitor).
• Not currently included in WHO
guidelines.
• Indicated for treatment-experienced
adult patients infected with only CCR5
tropic HIV-1 detectable strains, who haveevidence of viral replication and HIV-1
strains resistant to multiple antiretroviral
agents.185• Originator company and product name:
Pfizer, Selzentry. In April 2009, Pfizer and
GSK jointly announced the creation of
ViiV, a new joint venture focusing solely
on the R&D and commercialisationof HIV medicines.
• First approved by the U.S. Food andDrug Administration (FDA): 7 August
2007.186

ENTRY INHIBITOR
Price information:
Prices in US$ quoted by companies for
eligible developing countries

No reduced pricing available fordeveloping countries.

Spotlight on access issues:
Maraviroc (MVC) is classed as a CCR5 co-receptor antagonist that targets thepenetration of cells by the HIV virus. This drug option is predominately used in thedeveloped world as “salvage therapy” for patients who are already resistant to multiple
drug classes. Not all patients will benefit from this drug, as only some HIV viruses use
this CCR5 co-receptor. The recommendation is for patients to have a tropism test to
look for this co-receptor prior to treatment. Today, this test is not widely available andis expensive, at approximately US$ 1,900.193 In developing countries, where basic
laboratory monitoring is not always available, the reality of this type of testing being
available is limited.
Pfizer was invited to contribute a price for this publication and has communicated itdoes not offer a reduced price for developing countries.
Patents Pfizer obtained a patent in India in October 2007.190
This patent blocks the manufacture of generic formulations of MVC in India, limiting the
much-needed competition that historically has been shown to lead to price reductions.
Pfizer has applied for product patents and patents for the crystal form in Brazil, South
Africa, India, China and ARIPO191 and OAPI countries.192 To date, patents on the crystal
form have been granted in India, China, and ARIPO and OAPI countries.
Paediatrics The safety and efficacy of MVC in patients under 16 years of age have notbeen established.

• Not included in the WHO Model List of
Essential Medicines (EML).187• Basic patent was applied for by Pfizerin December 1999188 and is due to expire
in 2019. In May 2001, Pfizer applied foran additional patent more specificallyrelated to crystalline maraviroc.189

Médecins Sans Frontières • January 2010 • Untangling the Web of ARV Price Reductions • Please check utw.msfaccess.org • 21

ENFUVIRTIDE
General information• Therapeutic class: fusion inhibitor.
• Not currently included in WHO
guidelines.
• Indicated for treatment-experienced
adult patients who have evidence of viralHIV-1 replication despite ongoingantiretroviral therapy.114• Originator company and product name:Roche and Trimeris, Fuzeon.
• First approved by the U.S. Food andDrug Administration (FDA) in March
2003.115• Not included in the WHO Model List of
Essential Medicines (EML).116• Basic patent on enfuvirtide applied forby Duke University in June 1994,117 anddue to expire in 2014. Duke researchers
founded the pharmaceutical company
Trimeris, which began development of
enfuvirtide (previously called T-20) in
1996. In 1999, Trimeris entered into
partnership with Hoffmann-La Roche tocomplete the development of the drug.
Chiron also owns patents related toprocesses for producing enfuvirtide,118
which expired in 2005, but protection has
been extended until 2010 in some
European countries. A licensing agreement
was established between Roche andChiron in 2004.119 In November 2007,
Novartis Vaccines and Diagnostics filed asuit against Roche and Trimeris, alleging
infringement of Novartis's patent.120

FUSION INHIBITOR
Price information:
Prices in US$ quoted by companies for
eligible developing countries

No reduced pricing available fordeveloping countries.

Spotlight on access issues:
Enfuvirtide was the first drug developed in the fusion inhibitor class. The novel
mechanism of action targets the penetration of target cells by the HIV virus. This new
drug option is predominately used in the developed world as “salvage therapy” forpatients who are already resistant to multiple antiretroviral agents.
This drug is formulated as an injection and requires the patient or caregiver to learn
the technique of reconstituting powder vials with sterile water. Since the vials areformulated for single use, it requires the patient or caregiver to accurately syringe out
the required dose and volume. This is not adapted for use in resource-limited settings,
and the current price in the developed world of over US$ 25,000 per patient per year is
prohibitive for many developing countries that may have a need for this product.121
In Brazil, enfuvirtide is available at US$ 16,717 per patient per year.
Roche was invited to contribute a price for this publication and has communicated itdoes not offer a lower price for developing countries and is not planning to offer one
in the future.
Paediatrics The drug is approved for use in children over six years of age.

22 • Médecins Sans Frontières • January 2010 • Untangling the Web of ARV Price Reductions • Please check utw.msfaccess.org

RALTEGRAVIR (RAL)
General information

INTEGRASE INHIBITOR
Price information:
Prices in US$ quoted by companies for eligible developing countries• Therapeutic class: integrase inhibitor.
• Not currently included in WHO
guidelines.
• Indicated for treatment-experienced
adult patients who have evidence of viral
replication and HIV-1 strains resistant tomultiple antiretroviral agents.215

Daily dose

Merck
Category 1

Eligibility restrictions
RAL 400mg tablet

Category 2

see annexes 2 and 1021113 (1.525)

not available• Originator company and product name:
Merck & Co., Isentress.
• First approved by the U.S. Food andDrug Administration (FDA): 12 October
2007.
• Not included in the WHO Model List of
Essential Medicines (EML).
• World sales of originator product in2008: US$ 361.1 million;216 2007: US$ 41.3
million.
• The basic patent was applied for in
October 2002 by the Institute for
Research in Molecular Biology (IRBM),
Pomezia, Italy, one of Merck's researchsites.217 The patent is due to expire in
2022. In 2005, Merck and IRBM applied
for another patent on the potassium saltof RAL.218

Spotlight on access issues:
Raltegravir (RAL) is the first of a new class of drugs (integrase
inhibitors), which has a novel mechanism of action and noapparent cross-resistance with other ARVs.
RAL, unlike most protease inhibitors (PIs), does not require
boosting with ritonavir (RTV). This new drug option will be very
important for patients who are treatment-experienced and may
already be resistant to multiple antiretroviral agents.
In December 2009, WHO released new recommendations which
for the first time call for the need for a third-line therapy. As
many studies are ongoing, the drugs likely to have anti-HIV
activity in third-line regimens are boosted darunavir, etravirine
and raltegravir.
This is the first edition that includes tiered pricing by Merck for
raltegravir (see annex 10). The price is nevertheless extremely
high and therefore unaffordable for developing countries, andthere is no generic version available.

RAL pricing for category 2 countries (see annex 10) is still
unknown.
Patents Merck and IRBM applied for patents in many developing
countries with generic drug manufacturing capacity, such as
Brazil, China, India and South Africa. IRBM was granted a patentin India in December 2007219 which will expire in 2024.
Generic competition to reduce the price of the medicine will
therefore only be possible through voluntary licences issued by
the patent holder, or through compulsory licences issued by thegovernment.
Merck has also filed patent applications for the potassium salt
form of RAL which, if granted, will further extend Merck's
monopoly to 2027.
Paediatrics The safety and efficacy of RAL in patients under 16
years of age have not been established.

Médecins Sans Frontières • January 2010 • Untangling the Web of ARV Price Reductions • Please check utw.msfaccess.org • 23

EFAVIRENZ (EFV)
General information

NNRTI
Price information: Prices in US$ quoted by companies for eligible developing countries• Therapeutic class: non-nucleoside reverse
transcriptase inhibitor (NNRTI).
• Indicated for first- and second-line for
adults, adolescents and children (WHO 2006
guidelines).80

Daily
dose

Merck
Category 1

Cipla
(CF)

EmcureMatrix(CF)

Ranbaxy(CF)

Strides
(CF)

None

None

None

None

None

None

Category 2

see annexes 2 and 10

Eligibility restrictions

Aurobindo(CF)

EFV 50mg capsule--(0.120)(0.210)EFV 50mg tablet--(0.120)(0.210)

EFV 100mg capsule--EFV 200mg capsule3394 (0.360)

821 (0.750)• First approval by U.S. Food and Drug
Administration (FDA): 17 September 1998.81

EFV 200mg tablet

3

394 (0.360)

821 (0.750)

EFV 600mg tablet

1

237 (0.650)

657 (1.800)• Included in the 16th edition of the WHO
Model List of Essential Medicines (EML).82

EFV 30mg/ml
suspension--(0.094/ml)(0.151/ml)• World sales of originator product: 2008:
US$ 1.149 billion; 2007: US$ 956 million;
2006: US$ 791 million; 2005: US$ 680
million; 2004: US$ 621 million; and 2003:
US$ 544 million.83,84,85,86(CF) The Clinton Foundation has negotiated with this manufacturer for reduced prices on some formulations for countries in their consortium.
See Annex 13 for details.

• Originator companies and product brandnames: Bristol-Myers Squibb (BMS), Sustiva;
or Merck, Stocrin.

• The basic patent on EFV was filed in 1993
by Merck, and is due to expire in 2013.87(0.087)(0.150)152 (0.139)

171 (0.156)

146 (0.133)

128 (0.117)
97 (0.267)

107 (0.292)

97 (0.267)

107 (0.292) 145 (0.397) 103 (0.281)

Products included in the WHO List of Prequalified Medicinal Products (as of December 2009) are in BOLD in the table.

EFV 600mg tablet

Evolution of the lowest price quoted for eligible developing countries since 2002:

generic price

US$ ppylowest originator price
500
450
400
350
300
250
200
150
100
50
0

As of December 2009, there were seven generic sources of EFV 600mg listed on
the WHO List of Prequalified Medicinal Products and the lowest-priced product on
the List is shown here.

462
346

237

Since 2002, the originator price has decreased by 32%, while generic prices have
dropped by 79%.

97
Dec May Dec Apr Feb June June June June Dec
2002 2003 2003 2004 2005 2005 2006 2007 2008 2009

Month/Year

24 • Médecins Sans Frontières • January 2010 • Untangling the Web of ARV Price Reductions • Please check utw.msfaccess.org

EFAVIRENZ (EFV)

NNRTI

Spotlight on access issues:
Efavirenz (EFV) is a key drug for first-line treatment, very potent, once-daily dosing, andwell tolerated.
In its new 2009 guidelines, WHO recommends the use of EFV - in combination with two
NRTIs, one of which should be zidovudine (AZT) or tenofovir (TDF) - as a preferred firstline ART.375
EFV is also recommended as the preferred NNRTI for patients starting ART while on
tuberculosis treatment. Rifampicin, one of the main drugs used to treat TB, interacts
with nevirapine (NVP), resulting in lower blood levels of NVP. EFV, however, does nothave the same degree of interaction, and can be used as an alternative.
Its price, however, remains high, particularly for countries included in Merck's second
pricing tier (see annex 10), where the cost of EFV alone can exceed eight times the costof the most widely-used triple FDC (3TC/d4T/NVP).
Merck plans to phase out the 200mg and 50mg capsule formulations, which will be
replaced by tablets.
Patents Despite generic competition from a number of Indian manufacturers, EFV
remains expensive in countries where Merck holds patents that block the production
and sale of generics.
In countries where EFV is patented, governments and civil society groups have taken
various measures to ensure generic competition and lower prices, including:• In November 2006, Thailand issued a compulsory licence to import generic versions of
EFV from India. As a result, the Thai government is now purchasing EFV at US$ 106 per
patient per year (ppy), which is 80% lower than the previous price of US$ 511 ppy.88,89• In May 2007, Brazil, after numerous unsuccessful negotiations with Merck, issued acompulsory licence to import more affordable generic versions of EFV from India. At thetime, the price of EFV in Brazil was US$ 580 ppy and had not changed since 2003. Afterthe compulsory licence, Brazil began to import a generic version prequalified by WHO

for US$190 ppy. In February 2009, the public manufacturer Farmanguinhos (Fiocruz)
launched the national generic version for use in the Brazilian health system.90• In South Africa, Merck's refusal to allow sufficient generic competition contributed
significantly to the high price of the drug. This led the AIDS Law Project (ALP), acting on
behalf of the Treatment Action Campaign (TAC), to file a complaint before theCompetition Commission in November 2007. As a result, Merck recently agreed tolicense its product to other producers, opening the opportunity for generic competition
in South Africa, which is expected to drive down the price of EFV in the country.91• In India, a patent for the process of preparing form 1 of crystalline EFV was granted inJune 2005.92 Even though Merck does not hold a product patent for EFV, this recently
granted process patent appears to protect a key process for manufacturing EFV, andcould therefore have an impact on generic production of EFV in India. This patent has
therefore been opposed by Indian civil society organisations using the post-grant
opposition procedures enshrined in India's patent law.93
In addition, Gilead94 and BMS have filed patent applications related to combinations of
EFV with other ARVs. In particular, BMS's efforts to receive a patent for the once-a-day
pill EFV/FTC/TDF95 will have an impact on access to improved first-line ARV treatment in
the developing world. In India, the patent office has already rejected Gilead's
application,96 as combinations of known molecules are not patentable under India's
patent law.
Paediatrics Despite having received U.S. FDA approval for use in adults in 1998, there is
still no established dosing of EFV for children less than three years of age. There is anurgent need to establish the dosing of EFV for this age group.
In early 2008, BMS, which markets EFV in Europe, discontinued the manufacture of the
100mg capsule, further limiting options for paediatric patients. The oral solution, whileallowing more flexibility in dosing, must be discarded 30 days after being opened, andis not interchangeable on a mg per mg basis with the solid dosage forms. The
bioavailability of the oral solution is less than 70% of the oral dosage forms, and hencea larger dose is required to obtain the same blood levels.

Médecins Sans Frontières • January 2010 • Untangling the Web of ARV Price Reductions • Please check utw.msfaccess.org • 25

ETRAVIRINE
General information• Therapeutic class: non-nucleoside reverse
transcriptase inhibitor (NNRTI).
• Not currently indicated in WHO guidelines.
• Approved by U.S. Food and Drug
Administration (FDA) for treatmentexperienced adult patients who have evidenceof resistance to an NNRTI and otherantiretroviral agents.122• Originator company and product name:Tibotec Pharmaceuticals, Intelence.
• First approved by the U.S. FDA: 18 January
2008.123• Not included in the WHO Model List of
Essential Medicines (EML).
• The basic patent on etravirine was applied
for by Janssen Pharmaceutica in 1999 and isdue to expire in 2019.124 Both Janssen
Pharmaceutica and Tibotec are now part ofJohnson&Johnson.125,126

NNRTI
Price information:
Prices in US$ quoted by companies for
eligible developing countries

No reduced pricing available fordeveloping countries.

Spotlight on access issues:
In December 2009, WHO released new recommendations which for the first time call forthe need for third-line therapy. As many studies are ongoing, the drugs likely to haveanti-HIV activity in third-line regimens are boosted darunavir, etravirine and raltegravir.375
Etravirine was approved by the U.S. FDA in January 2008, and received marketing
approval by the EMEA in August 2008. It has not yet been approved by any developing
country health authority.
Tibotec was asked to provide a price for this product for inclusion in this publication,and the company communicated that etravirine will be included in its “Global Access
Program.”However, for the second year in a row, no price was provided by Tibotec.
Patents Patents have been applied for widely in the developing world, including in
Africa. In September 2006, Janssen Pharmaceutica was granted a molecule patent inIndia.127
This patent will block the development of generic formulations of etravirine, unlesslicences - voluntary or compulsory - are issued to generic companies for the
manufacture of affordable versions of the drug.
It is important to note that Tibotec has applied for the subsequent patents, eventhough Janssen Pharmaceutica is the holder for the molecule patent. To prolong thepatent monopoly it is expected that a number of applications relating to etravirine will
be for new forms and combinations.
Paediatrics Etravirine is not approved for use in children today. A waiver of paediatricstudies from birth to two months was granted by EMEA on grounds that the medicine
does not represent significant therapeutic benefit over existing treatments.128

26 • Médecins Sans Frontières • January 2010 • Untangling the Web of ARV Price Reductions • Please check utw.msfaccess.org

NEVIRAPINE (NVP)
General information

NNRTI
Price information: Prices in US$ quoted by companies for eligible developing countries
Daily
dose

• Therapeutic class: non-nucleoside reverse
transcriptase inhibitor (NNRTI).
• Indicated for first- and second-line for
adults, adolescents and children (WHO 2006
guidelines).202,203• Originator company and product brand
name: Boehringer Ingelheim (BI), Viramune.
• First approval by U.S. Food and Drug
Administration (FDA): 21 June 1996.204

Boehringer Ingelheim
Category 1

Category 2

see annex 2

Eligibility restrictions

Aurobindo
(CF)

Cipla
(CF)

EmcureHuahai(CF)

Matrix(CF)

Ranbaxy(CF)

Strides

None

None

None

None

None

None

None

42 (0.058)

35 (0.048)

42 (0.058) 47 (0.065) 42 (0.057)

NVP 200mg tablet

2

219 (0.300)

438 (0.600) 42 (0.058)

35 (0.048)

NVP 10mg/ml
suspension

20ml

380
(0.052/ml)

533(0.073/ml)

66(0.009/ml)

73(0.010/ml)(CF) The Clinton Foundation has negotiated with this manufacturer for reduced prices on some formulations for countries in their consortium.
See Annex 13 for details.
Products included in the WHO List of Prequalified Medicinal Products (as of December 2009) are in BOLD in the table.

• Included in the 16th Edition of the WHO
Model List of Essential Medicines (EML).205• The basic patents on NVP were applied forby BI in November 1990, and are due toexpire in November 2010.210 BI also applied fora patent on the hemihydrate form of NVP,
used in the suspension in 1998, which is due
to expire 2018.211 Additionally, BI applied for apatent on the extended-release formulation ofnevirapine in 2008, which is due to expire in
2028.212

NVP 200mg tablet

US$ ppy• World sales of originator product: 2007:
US$ 412 million; 2006: US$ 370 million;
2005: US$ 386 million; 2004: US$ 378
million.206,207,208,209

Evolution of the lowest price quoted for eligible developing countries
since 2001:

generic pricelowest originator price500
450
400 438350
300
250
200 150
150
100
50
0

As of December 2009, there were ten generic sources of NVP 200mg
listed on the WHO List of Prequalified Medicinal Products and thelowest-priced product on the List is shown here.
219

While it was a positive result that the originator dropped its price by
50% in 2007, the generic price has decreased by almost 80% over thisperiod, and today is now approximately 16% of the originator price.

35

Oct Jun Dec May Dec Apr Feb June June June June Dec
2001 2002 2002 2003 2003 2004 2005 2005 2006 2007 2008 2009

Month/Year

Médecins Sans Frontières • January 2010 • Untangling the Web of ARV Price Reductions • Please check utw.msfaccess.org • 27

NEVIRAPINE (NVP)

NNRTI

Spotlight on access issues:
Nevirapine (NVP) is a widely-used ARV, predominately in first-line regimens. It has been
an important component of the fixed-dose combinations that have fostered treatment
scale-up in resource-limited settings.
The price of NVP has decreased dramatically over the past years as a result of genericcompetition.
Patents Boehringer Ingelheim (BI) has obtained the basic patent on NVP in several
developing countries, but no patent could be obtained in countries such as India,
Brazil, China or Thailand, which were not granting patents on medicines at the time.
Many developing countries, where NVP is under patent, import generic versions of NVP
by making use of TRIPS flexibilities.
However, after India introduced patent protection for pharmaceutical products in 2005,
BI applied for a patent on the hemihydrate form of NVP, which relates to the paediatricsuspension. Civil society groups in India filed a pre-grant opposition to BI's patentapplication in May 2006. In June 2008, the patent application on the NVP hemihydrate
was rejected by the Indian patent office, allowing for unrestricted competition on thepaediatric formulation. This constitutes an important victory for Indian civil society, as
this is the first patent application related to a HIV medicine to have been rejected as aresult of a pre-grant opposition.213

Paediatrics NVP is approved for use and is widely used in children.
To give clinicians flexibility in prescribing ARV regimens, there is a need for a simple
adapted formulation of NVP. The Paediatric Aids Working Group at WHO has given“urgent” priority to the development of a 50mg tablet.
In addition, with the increased prevalence of TB/HIV co-infection, there is a need forfurther studies into the interactions between NVP and the TB drugs, rifampicin andrifabutin in children.214
BI has a NVP donation programme for the prevention of mother-to-child transmission.
This, however, does not cover treatment for children. When BI announced a reduction of
50% for NVP in mid 2007, it did not include the NVP 10mg/ml solution, where a pricedrop would have had a considerable impact. It therefore costs more to treat a 10kg
child with NVP, than an adult.
Generic manufacturers have been developing triple fixed-dose combinations including
NVP, and today three paediatric triple FDCs that include NVP are listed on the WHO
Prequalification List of Medicinal Products.

28 • Médecins Sans Frontières • January 2010 • Untangling the Web of ARV Price Reductions • Please check utw.msfaccess.org

ABACAVIR (ABC)
General information• Therapeutic class: nucleoside reverse
transcriptase inhibitor (NRTI).
• Indicated for first- and second-line for
adults, adolescents and children (WHO2006 guidelines).21,22• Originator company, and productbrand name: GlaxoSmithKline (GSK),
Ziagen. In April 2009, Pfizer and GSK
jointly announced the creation of ViiV, a
new joint venture focusing solely on the
R&D and commercialisation of HIV
medicines.
• First approval by U.S. Food and Drug
Administration (FDA): 17 December
1998.23

NRTI
Price information: Prices in US$ quoted by companies for eligible developing countries
Daily dose
Eligibility restrictions• The basic patents on ABC wereapplied for by GSK in 198930 and 1990,31
and these are due to expire in 2009
and 2010, respectively. GSK
subsequently applied for an additional
patent on the hemisulfate salt of ABC in
199832 and on compositions of ABC
particularly relevant for paediatric use in
1999,33 which are due to expire in 2018and 2019, respectively.

Aurobindo (CF)Cipla (CF)Matrix (CF)Ranbaxy

Stridessee annex 2

None

None

None

None

None

243 (0.333)

341 (0.467)

ABC 300mg tablet

2437 (0.599)

261 (0.358)

237 (0.325)

ABC 20mg/ml oral solution

10ml

230 (0.063)

230 (0.063/ml)

204(0.056/ml)

ABC 60mg tablet

4

183 (0.125)

134 (0.092)

183 (0.125)

730 (0.500)(CF) The Clinton Foundation has negotiated with this manufacturer for reduced prices on some formulations for countries in their consortium.
See Annex 13 for details.
Products included in the WHO List of Prequalified Medicinal Products (as of December 2009) are in BOLD in the table.

ABC 300mg tablet

generic price2500

As of December 2009, there were four generic sources of ABC 300mg listedon the WHO List of Prequalified Medicinal Products and the lowest-priced
product on the List is shown here.

2628

2000
US$ ppy

Evolution of the lowest price quoted for eligible developing countries
since 2001:

lowest originator price3000• Included in the 16th Edition of the
WHO Model List of Essential Medicines(EML).24• World sales of originator product for
2008: US$ 175 million; 2007: US$ 215
million; 2006: US$ 230 million; 2005:
US$ 268 million; 2004: US$ 290
million.25,26,27,28,29

GSK

1500

Since 2001, the originator price has decreased by 68%, while the generic pricehas decreased by 91%.

1000 1387
500

437

0

237
Oct Jun Dec May Dec Apr Feb Jun
01 02 02 03 03 04 05 05

Jun
06

Jun
07

Jun Dec
08 09

Month/Year

Médecins Sans Frontières • January 2010 • Untangling the Web of ARV Price Reductions • Please check utw.msfaccess.org • 29

ABACAVIR (ABC)
Spotlight on access issues:
In December 2009, WHO released new recommendations for antiretroviral therapy for
HIV in adults and adolescents. Recommendations for second-line treatment include PIs
such as ritonavir-boosted atazanavir (ATV) or LPV/r, and simplified NRTI options.
Abacavir (ABC) and didonasine (ddI) are no longer recommended as the backbones of
NRTI in second-line therapy.375

NRTI
ABC in October 2007 after it was opposed by civil society groups in July 2006 in a pregrant opposition procedure.34 However, the patent more specifically related to paediatricformulations was granted in December 2007.35 This recently-granted patent raises
concerns over the continued generic availability of the ABC paediatric formulation, which
is an important option for young children with HIV/TB co-infection.
Paediatrics ABC is approved for use in children.

Even though the price of ABC has fallen by almost 91% in generic pricing since 2001,
the current lowest generic price is more than two times the lowest price of tenofovir(TDF) or zidovudine (AZT). Additionally, GSK's differential pricing structure (see annex 2)
excludes non-African countries that are not funded by the Global Fund. This structure
leaves these countries paying more than US$ 4,300 per patient per year.38
Patents As shown in the graph, the price of ABC decreased significantly with the arrivalof generic competition. This was possible because GSK could not apply for the basic
patents on ABC in countries with generic production capacity such as India, which did
not grant patents on pharmaceuticals at the time. However, GSK has applied for patentson the hemisulfate salt of ABC and on compositions of ABC particularly relevant for
paediatric use in India. GSK withdrew its patent application on the hemisulfate salt of

There is a liquid formulation and today, two generic sources of ABC oral solution, andtwo generic sources of ABC 60mg paediatric tablet are listed in the WHO List ofPrequalified Medicinal Products.
ABC will continue to be an important drug for HIV/TB co-infected small children, whohave limited choices of ARVs because of drug interactions between TB drugs andnevirapine (NVP), and because of the lack of dosage data on efavirenz (EFV) for children
under three.
Today, once-daily dosing of ABC is only recommended for patients over 12 years of age;more studies are needed to confirm the safety of daily dosing of ABC in children.36

30 • Médecins Sans Frontières • January 2010 • Untangling the Web of ARV Price Reductions • Please check utw.msfaccess.org

DIDANOSINE (ddI)
General information

NRTI
Price information: Prices in US$ quoted by companies for eligible developing countries
Bristol-Myers Squibb• Therapeutic class: nucleoside reverse
transcriptase inhibitor (NRTI).
• Indicated for second-line for adults,
adolescents and children.75• Originator company and product brand
name: Bristol-Myers Squibb (BMS), Videx,
Videx EC.
• First approval by U.S. Food and Drug
Administration (FDA): October 1991 forchewable tablets; October 2000 for entericcoated capsules.76• Included in the 16th Edition of the WHO
Model List of Essential Medicines (EML).77• World sales of originator product: In 2005:
US$ 174 million; 2004: US$ 274 million;
2003: US$ 354 million. After 2005, there areno sales figures listed in the company's
annual report.78• The basic patent on ddI filed in 1985 by the
National Institutes of Health (NIH), a U.S.
government research institute, has expired,
but BMS holds patents on improved
formulations in some countries, which run
until 2012 and 2018.

Daily
dose

Category 1

Category 2

see annexes 2 and 7

Eligibility restrictions

Aurobindo
(CF)

Cipla

Ranbaxy

None

None

None

ddI 25mg tablet

5

212 (0.116)

433 (0.237)

115 (0.063)

228 (0.125)

ddI 50mg tablet--(0.158)(0.237)(0.079)(0.115)

ddI 100mg tablet

4

310 (0.212)

366 (0.251)

207 (0.142)

188 (0.129)

242 (0.166)

ddI 150mg tablet--(0.308)(0.348)(0.225)(0.167)

ddI 200mg tablet--(0.283)(0.257)

ddI 125mg enteric-coated -capsule(0.186)

ddI 200mg entericcoated capsule(0.224)--

ddI 250mg entericcoated capsule1

223 (0.611)

249 (0.683)

172 (0.471)

103 (0.283)

ddI 400mg entericcoated capsule1288 (0.789)

322 (0.881)

270 (0.740)

132 (0.363)

12ml

276
(12.590/2g)

308(14.057/2g)

88(4.000/2g)

ddI 2g powder forreconstitution (Finalconcentration 10mg/ml)(CF) The Clinton Foundation has negotiated with this manufacturer for reduced prices on some formulations for countries
in their consortium. See Annex 13 for details.
Products included in the WHO List of Prequalified Medicinal Products (as of December 2009) are in bold.

Médecins Sans Frontières • January 2010 • Untangling the Web of ARV Price Reductions • Please check utw.msfaccess.org • 31

DIDANOSINE (ddI)
ddl EC 400mg capsule

NRTI
generic pricelowest originator price

350
300

271

288

270

270

US$ ppy250

Spotlight on access issues:
In December 2009, WHO released new recommendations for antiretroviral therapy for HIV in adults
and adolescents. For second-line treatment, protease inhibitors such as ritonavir-boosted ATV or LPV/r,and simplified NRTI options are recommended. Abacavir (ABC) and didanosine (ddI) are no longer
recommended as one of the NRTI backbones in second-line therapy.375

200

BMS's differential pricing structure limits the prices quoted above to sub-Saharan Africa and lowincome countries. This structure leaves middle-income countries paying more than US$ 3,200 per
patient per year for ddI enteric-coated (EC) 400mg capsules, which is prohibitive for many of thesecountries.369

150
100
50
0
May Dec April Feb June June June June Dec
2003 2003 2004 2005 2005 2006 2007 2008 2009

Month/Year

Evolution of the lowest price quoted for developing countries since2003:
As of December 2009, there was one generic source of ddI 400mg
EC listed on the WHO List of Prequalified Medicinal Products and thelowest-priced product on the List is shown here.

In 2006, BMS discontinued the sale of the chewable / dispersible buffered tablets in the U.S. The
enteric-coated capsules are more adaptable as they can be taken once daily and, unlike the tablets,
do not contain a buffer. The buffer has been associated with stomach upsets and a bitter and chalkytaste.
In December 2009, BMS discontinued the sale and manufacturing of ddl 200mg globally due to low
demand for the product.
Today, four generic ddI EC formulations are listed in the WHO List of Prequalified Medicinal Products.
Patents The patent on enteric-coated capsules was granted in Brazil, China and ARIPO and OAPI
countries. No application claiming a patent on enteric-coated capsules has been published in India,
allowing a generic version to be launched. However, where the patent has been granted in otherdeveloping countries, the importation of the more affordable version from India is blocked.
Paediatrics For younger children, the only options are buffered tablets that come with a high pillburden, or the ddI powder for reconstitution, which requires multiple dilutions, first with water andthen with an antacid, to obtain the final concentration. Once reconstituted, the solution must be
refrigerated and must be discarded after 30 days.
BMS offers no differential price for the ddI EC 125mg, which is the best-adapted option for older
children who can swallow. The price in the developed world, at more than US$ 1,000 per patient year,
is prohibitive for the developing world.

32 • Médecins Sans Frontières • January 2010 • Untangling the Web of ARV Price Reductions • Please check utw.msfaccess.org

EMTRICITABINE (FTC)
General information• Therapeutic class: nucleoside reverse
transcriptase inhibitor (NRTI).
• Indicated for first- and second-line for
adults.97

NRTI
Price information: Prices in US$ quoted by companies for eligible developing countries
Daily dose
Eligibility restrictions
FTC 200mg capsule1

Aurobindo

MatrixNone

None

67 (0.183)

79 (0.217)

Products included in the List of WHO prequalified Medicinal Products (as ofDecember 2009) are in bold.

• First approval by U.S. Food and Drug
Administration (FDA): July 2003.98• Included in the 16th Edition of the
WHO Model List of Essential Medicines(EML).99• World sales of originator product:
2008: US$ 31.1 million; 2007: US$ 31.5
million; 2006: US$ 36.3 million; 2005:
US$ 47.4 million; 2004: US$ 57.6
million.100,101,102• The basic patent on FTC andlamivudine (3TC) was filed by IAF
Biochem in 1990 and is due to expire in2010. As the molecular structure of FTC
and 3TC are very closely related, thesame patent covers both these drugs.103,104• Emory University also applied for aseries of patents that relate to FTC
between 1990 and 1992.105,106 These are
due to expire between 2010 and 2012. In
2005, Gilead acquired the royalty interest
for FTC under a US$ 525 million
agreement with Emory University.107

Spotlight on access issues:
Emtricitabine (FTC) produced by Gilead is not offered as part of the company's “Access Program” and is also neither
registered nor marketed in developing countries. It is, however, available in co-formulation with tenofovir (TDF).
According to the WHO treatment guidelines, “FTC is an equivalent alternative to lamivudine (3TC) as it is structurally
related to 3TC, shares the same efficacy against HIV and hepatitis B virus and has the same resistance profile.”111
The new WHO 2009 guidelines recommend using TDF with either FTC- or 3TC-containing antiretroviral regimens in all
HIV/HBV co-infected individuals needing treatment.375
Patents Although basic patents on FTC could not be applied for in India because the country did not grant patents
on pharmaceuticals at the time, Gilead reported holding patent rights on FTC in 45 other developing countries.108
In mid 2006, Gilead signed licensing agreements with ten generic manufacturers in India, allowing them tomanufacture and export generic versions of Gilead's products to a limited list of countries, in return for the paymentof a 5% royalty.109
Paediatrics FTC is approved for use in children and has the advantage of once-daily dosing.
The paediatric formulation produced by Gilead is a solution that requires refrigeration prior to dispensing and must
be used within three months and stored at temperatures below 25°C. This is not adapted to developing world
needs.
The Paediatric AIDS Working Group at WHO has given “important” priority to the development of a 35mg tablet.110

Médecins Sans Frontières • January 2010 • Untangling the Web of ARV Price Reductions • Please check utw.msfaccess.org • 33

LAMIVUDINE (3TC)
General information

NRTI
Price information: Prices in US$ quoted by companies for eligible developing countries• Therapeutic class: nucleoside reverse
transcriptase inhibitor (NRTI).

Daily
dose

• Indicated for first- and second-line for
adults and adolescents, and for first-line only
for children (WHO 2006 guidelines)142

Eligibility restrictions• Originator company and product brand
name: GlaxoSmithKline (GSK), Epivir. In April
2009, Pfizer and GSK jointly announced thecreation of ViiV, a new joint venture focusing
solely on the R&D and commercialisationof HIV medicines.

3TC 150mg tablet

2

3TC 300mg tablet

1

3TC 10mg/ml oral solution

10ml

GSK

Aurobindo
(CF)

Cipla
(CF)

Matrix(CF)

Ranbaxy(CF)

Strides(CF)

see annex 2

None

None

None

None

None

64 (0.087)

39 (0.053)

35 (0.048)

34 (0.046) 39 (0.054) 37 (0.050)

24 (0.067)

41 (0.113)

34 (0.092)

84 (0.023/ml)

29 (0.008/ml) 37 (0.010/ml)(CF) The Clinton Foundation has negotiated with this manufacturer for reduced prices on some formulations for countries in theirconsortium. See annex 13 for details.
Products included in the WHO List of Prequalified Medicinal Products (as of December 2009) are in bold.

• First approval by U.S. Food and Drug
Administration (FDA): November 1995.143• Included in the 16th Edition of the WHO
Model List of Essential Medicines (EML).144
3TC 150mg tablet• World sales of originator product: 2008:
US$ 225 million; 2007: US$ 309 million;
2006: US$ 398 million; 2005: US$ 398
million; 2004: US$ 549 million.145,146,147• GSK obtained a license from IAF to
manufacture 3TC and filed additional patents
on new forms of 3TC in 1992, which are due
to expire around 2012.150

lowest originator price250

As of December 2009, there were nine generic sources of 3TC 150mg
listed on the WHO List of Prequalified Medicinal Products and thelowest -priced product on the List is shown here.

234

200
US$ ppy• The basic patent on emtricitabine (FTC) and
3TC was filed by IAF Biochem in 1990 and isdue to expire in 2010. As the molecular
structure of FTC and 3TC are very closely
related, the same patent covers both thesedrugs.148,149

Evolution of the lowest price quoted for eligible developing countries
since 2001:

generic price

150
91

100

64
50
34

0
Oct
2001

June Dec May Dec Apr Feb June June June June Dec
2002 2002 2003 2003 2004 2005 2005 2006 2007 2008 2009
Month/Year• GSK also applied for a new formulation
patent in 1998. This patent was granted in
Brazil, China and in ARIPO countries.151

34 • Médecins Sans Frontières • January 2010 • Untangling the Web of ARV Price Reductions • Please check utw.msfaccess.org

Spotlight on access issues:
3TC is a widely-used ARV both in first- and second-line
regimens. It has been an important component of fixed-dose
combinations that have fostered treatment scale-up inresource-limited settings.

patient per year. GSK is using its monopoly rights to block local
production or importation of more affordable generic versions of
3TC.

3TC is also active against hepatitis B, and hence plays animportant role in co-infected patients.

Paediatrics 3TC is approved for use and is widely used inchildren.

The 2009 revision of the WHO guidelines recommend using
TDF with either emtricitabine (FTC) or 3TC-containing
antiretroviral regimens in all HIV/HBV co-infected individuals
needing treatment.375

Generic manufacturers have been developing both double andtriple fixed-dose combinations containing 3TC. As of December
2009 there were four paediatric triple FDCs containing 3TC listed
in the WHO Prequalification List of Medicinal Products.

Patents As the graph illustrates, the price of 3TC decreased
dramatically after the onset of generic competition. Genericcompetition for 3TC originated in countries with
manufacturing capacity where the drug is not under patent,such as India, Thailand and Brazil.

To give clinicians flexibility in prescribing ARV regimens, there is aneed for a single simple adapted formulation of 3TC. The
Paediatric AIDS Working Group at WHO has given “important”
priority to the development of a 30mg tablet.

In China, where GSK still owns exclusive rights on 3TC, the priceof the medicine remains very high, at around US$ 1,839 per

Today, once-daily dosing of 3TC is only recommended for patientsover 16; more studies are needed to confirm the safety of daily
dosing of 3TC in children.152

Médecins Sans Frontières • January 2010 • Untangling the Web of ARV Price Reductions • Please check utw.msfaccess.org • 35

STAVUDINE (d4T)
General information

NRTI
Price information: Prices in US$ quoted by companies for eligible developing countries• Therapeutic class: nucleoside reverse
transcriptase inhibitor (NRTI).
• Indicated for first-line for adults,
adolescents and children (WHO 2006
guidelines).236,237• WHO updated the 2006 guidelines torecommend a reduction in dose of d4T 40mg
to 30mg for all weight categories ofpatients.155

Bristol-Myers Squibb
Daily
dose

Category 1

Category 2

see annexes 2 and 7

Eligibility restrictions

Aurobindo
(CF)

Cipla
(CF)

Matrix(CF)

Ranbaxy(CF)

Strides
(CF)

None

None

None

None

None

24 (0.033)

26 (0.035)

22 (0.030)

d4T 15mg capsule--(0.082)(0.093)(0.029)(0.024)

d4T 20mg capsule--(0.089)(0.093)(0.030)(0.025)

d4T 30mg capsule2

48 (0.066)

68 (0.093)

22 (0.030)

26 (0.035)

51 (0.007/ml)

58 (0.008/ml) 66 (0.009/ml) 44 (0.006/ml)• Originator company and product brand
name: Bristol-Myers Squibb (BMS), Zerit.

d4T 1mg/ml powder for syrup 20ml

• First approval by U.S. Food and Drug
Administration (FDA): December 1994.238(CF) The Clinton Foundation has negotiated with this manufacturer for reduced prices on some formulations for countries in theirconsortium. See annex 13 for details.

• Included in the 16th Edition WHO Model Listof Essential Medicines (EML).239

Products included in the WHO List of Prequalified Medicinal Products (as of December 2009) are in bold.

• World sales of originator product: 2006:
US$ 155 million; 2005: US$ 216 million; 2004:
US$ 272 million; 2003: US$ 354 million. After
2006, there are no sales figures listed in thecompany's annual report.240,241

d4T 30mg capsulegeneric price

Evolution of the lowest price quoted for eligible
developing countries since 2003:

lowest originator price

US$ ppy• d4T was the result of U.S. public sector
research. It was originally synthesised by theMichigan Cancer Foundation in 1966 under agrant from the National Cancer Institute.242
Researchers from Yale University thendiscovered its antiretroviral activity andapplied for a patent in December 1987,
mostly in developed countries, for the use ofd4T to treat patients infected withretroviruses.243 This patent should have
expired in December 2007, but the protection
was extended until the end of 2008 in the
U.S. and until 2011 in most European
countries. BMS markets d4T under amarketing and distribution license from Yale
University.

60
50
40
30
20
10
0

49
48

As of December 2009, there were six generic sources ofd4T 30mg listed on the WHO List of Prequalified
Medicinal Products and the lowest-priced product on the
List is shown here.

36
22
May Dec Apr Feb June June June June Dec
2003 2003 2004 2005 2005 2006 2007 2008 2009

Month/Year• Patents have expired in most countries atthis point.

36 • Médecins Sans Frontières • January 2010 • Untangling the Web of ARV Price Reductions • Please check utw.msfaccess.org

STAVUDINE (d4T)

NRTI

Spotlight on access issues:
For many years, the stavudine (d4T)-containing regimen has
played a crucial role in ART scale-up in resource-limited
settings, due to its availability in a fixed-dose combination
and, most importantly, its low cost. d4T remains a widelyused ARV in first-line regimens.
In December 2009, WHO released new recommendations for
antiretroviral therapy for HIV in adults and adolescents. These
new recommendations advise countries to phase out
stavudine-based regimens because of their long-term
irreversible side effects and to move towards zidovudine(AZT) or tenofovir (TDF)-based first-line regimens.375
Patents Yale University did not apply for patents in mostdeveloping countries except for South Africa. Therefore,
generic manufacturers from countries with manufacturing
capacity, such as Brazil, China, India or Thailand could legally
manufacture and export affordable generic versions of d4T.
In South Africa, where BMS marketed d4T under an exclusive

license from Yale, the drug was 34 times more expensive than
generic versions available in other countries. This prompted apatent controversy in March 2001, particularly as the medicine
had been developed with public funds. After pressure fromresearchers, students, and access advocates, Yalerenegotiated its license with BMS to allow the importation of
more affordable generic versions of d4T to South Africa.244
Paediatrics d4T is approved for use in children.
The paediatric formulation of d4T is not adapted for resourcelimited settings as it is supplied as a powder that requires
reconstitution with clean, safe water, and once reconstituted,
must be refrigerated.
Generic manufacturers have been developing both double andtriple fixed-dose combinations including d4T. For paediatricuse, two d4t-containing triple FDCs are listed on the WHO Listof Prequalified Medicinal Products.

Médecins Sans Frontières • January 2010 • Untangling the Web of ARV Price Reductions • Please check utw.msfaccess.org • 37

TENOFOVIR DISOPROXIL FUMARATE (TDF)
General information

Price information: Prices in US$ quoted by companies for eligible developing countries• Originator company and product brand
name: Gilead, Viread.
• First approval by U.S. Food and Drug
Administration (FDA): October 2001.248

Aurobindo

Gilead• Therapeutic class: nucleotide reverse
transcriptase inhibitor (NtRTI).
• Indicated for first- and second-line for
adults and adolescents (WHO 2006
guidelines).246,247

NtRTI

Daily dose Category 1
Eligibility restrictions
TDF 300mg tablet

207 (0.567)

Matrix(CF)

Strides (CF)

None

None

None

100 (0.275)

116 (0.317)

149 (0.408)

Category 2

see annexes 2 and 9
1

Cipla (CF)365 (1.000)

None
116 (0.317)(CF) The Clinton Foundation has negotiated with this manufacturer for reduced prices on some formulations for countries in theirconsortium. See annex 13 for details.
Products included in the WHO List of Prequalified Medicinal Products (as of December 2009) are in bold.

• Included in the 16th Edition of the WHO
Model List of Essential Medicines (EML).249• The basic patent on tenofovir was applied
for by the Academy of Sciences of the former
Czechoslovakia in 1986. It has now expired inmost countries.255 Gilead subsequently applied
for additional patents related to tenofovir
disoproxil in 1997.256 and for the fumarate saltof tenofovir disoproxil in 1998.257 These are
due to expire in 2017 and 2018, respectively.
In addition, Gilead and BMS have applied forpatents on fixed-dose combinations of
TDF/FTC and TDF/FTC/EFV which, if granted indeveloping countries, will expire not earlier
than 2024 and 2026 respectively.258,259

TDF 300mg tablet

Evolution of the lowest price quoted for eligible developing countries
since 2003:

generic pricelowest originator priceAs of December 2009, there were three generic sources of TDF 300mg
listed on the WHO List of Prequalified Medicinal Products and thelowest-priced product on the List is shown here.

500
400
US$ ppy• World sales of originator product: 2008:
US$ 621 million; 2007: US$ 613 million;
2006: US$ 689 million; 2005: US$ 778
million; 2004: US$ 783 million.250,251,252,253,254

475

There has been a 73% decrease in the generic price since 2006, and a
56% decrease in the lowest originator price since 2003.

365

300
207

200
100
0

100
May Dec Apr Feb June
2003 2003 2004 2005 2005

June June June Dec
2006 2007 2008 2009

Month/Year38 • Médecins Sans Frontières • January 2010 • Untangling the Web of ARV Price Reductions • Please check utw.msfaccess.org

TENOFOVIR DISOPROXIL FUMARATE (TDF)

NtRTI

Spotlight on access issues:
For many years, a regimen containing stavudine (d4T) has played a crucial role in ART
scale-up in resource-limited settings, due to its availability in a fixed-dose combination,
most importantly, its low cost. d4T remains a widely-used ARV in first-line regimens.
In December 2009, WHO released new recommendations for antiretroviral therapy for HIV
in adults and adolescents. These new recommendations advise countries to phase out
stavudine-based regimens because of its long-term irreversible side effects and to movetowards zidovudine or tenofovir-based first-line regimens. It is time for countries to invest
in a more robust, TDF-containing first-line regimen, such as TDF/3TC/EFV or TDF/FTC/EFV,
which is one pill, once a day. While the price today is still higher than a d4T-containing
regimen, there is a need to generate greater demand which will, in turn, increase thecompetition needed to further decrease prices.375
For second-line treatment, TDF in combination with lamivudine (3TC) or emtricitabine(FTC) are the recommended NRTI backbones to be added to a boosted protease inhibitor,
if stavudine or zidovudine have been used in the first-line regimen.
TDF is also active against hepatitis B and therefore plays an important role in co-infectedpatients.
For HIV patients requiring treatment for hepatitis B, the first- and second-line treatment
should contain TDF and either 3TC or FTC.
Gilead has a differential pricing structure (see annex 9) that has been expanded toinclude lower-middle-income countries not included in its Access Program.
Patents Gilead has applied for patents related to TDF in many developing countries,
including India, Brazil and China. In Brazil and India, these patent applications have been
opposed by civil society groups, as well as by some generic manufacturers.
In a major victory for access to medicines, the Indian patent office rejected several patentapplications relating to TDF in September 2009. The patents were rejected on the
grounds that they lack an inventive step - they do not meet the requirement of enhanced
efficacy stipulated under Section 3(d) of India's patent law. Further, combinations ofknown molecules are not patentable under Indian patent law.260,261,262

Nevertheless, divisional applications (a type of patent application which contains matterfrom a previously filed application) have been filed by Gilead for this and other patentapplications. This means that although the patent was not granted, the patent applications
are still pending before the patent office.
The same is true in Brazil, where an estimated 37,000 PLHA are on TDF-based therapies. In
April 2008, the government declared tenofovir as a medicine of public interest for priority
examination purposes. The National Institute on Industrial Property (INPI – Brazilian patentoffice) published the patent rejection for TDF on 30 June 2009. However, Gilead has
requested a divisional patent, which has been opposed by civil society groups.
Following oppositions (by members of Indian and Brazilian civil society) to the grant of its
patents in India, Gilead signed licensing agreements with ten generic manufacturers in India,
allowing them to manufacture and export generic versions of Gilead's products to a limited
pre-defined list of countries, against the payment of a 5% royalty.263
Manufacturers that have signed these agreements are unable to supply countries such as
Brazil and China, leaving these countries unable to benefit from competitive prices andimprove access. After negotiation with Gilead, Brazil is today paying US$ 927 per patient
per year, over ten times the best available generic price.
Such licensing agreements can contribute to increased competition and improved accessto affordable medicines, but should also be offered to manufacturers outside India, andshould not include geographic market limitations.
Paediatrics TDF is currently not approved for children younger than 18 years in the U.S.
Gilead is currently sponsoring two Phase III trials, the first involving adolescents (12-18
years) and the second involving children (2-12 years), using an oral powder formulation.
Results from these studies are expected in 2010 and will contribute to the urgent needfor dosing information and information on medium- and long-term toxicity in children.
In March 2009, U.S. FDA granted TDF an Orphan Drug designation for treatment of
paediatric HIV infections.370 Gilead is now entitled to seven years of marketing exclusivity
for the designated paediatric indication, tax credits for clinical research and can apply for
grants to defray the cost of clinical trials.371

Médecins Sans Frontières • January 2010 • Untangling the Web of ARV Price Reductions • Please check utw.msfaccess.org • 39

ZIDOVUDINE (AZT or ZDV)General information

NRTI
Price information: Prices in US$ quoted by companies for eligible developing countries
Daily
dose

• Therapeutic class: nucleoside reverse
transcriptase inhibitor (NRTI).
• Indicated for first- and second-line for
adults, adolescents and children (WHO 2006
guidelines).320,321• Originator company and product brand
name: GlaxoSmithKline (GSK), Retrovir. In April
2009, Pfizer and GSK jointly announced thecreation of ViiV, a new joint venture focusing
solely on the R&D and commercialisationof HIV medicines.
• First approval by U.S. Food and Drug
Administration (FDA): March 1987.322

Eligibility restrictions• AZT was first discovered in 1964 as an anticancer medicine. The U.S. National Institutesof Health did the majority of the research thatshowed the drug's effectiveness as anantiretroviral. Glaxo Wellcome filed for patents
on AZT for the treatment of AIDS and brought
the drug onto the market in 1987 as one of
the most expensive ever sold. Patents have
expired in most countries at this point.

Aurobindo
(CF)

Cipla
(CF)

Matrix(CF)

Ranbaxy

see annex 2

None

None

None

None

97 (0.133)

99 (0.135)

AZT 300mg tablet

2

161 (0.221)

110 (0.150)

97 (0.133)

AZT 100mg capsule--(0.122)(0.092)(0.050)AZT 250mg capsule--(0.276)AZT 10mg/ml syrup

20ml

234 (0.032/ml)

73 (0.010/ml) 80 (0.011/ml)(CF) The Clinton Foundation has negotiated with this manufacturer for reduced prices on some formulations forcountries in their consortium. See annex 13 for details.
Products included in the WHO List of Prequalified Medicinal Products (as of December 2009) are in bold.
AZT 300mg tablet

US$ ppy• Included in the 16th Edition of the WHO
Model List of Essential Medicines (EML).323• World sales of originator product: 2005:
US$ 84 million; 2004: US$ 80 million. After
2005, there are no sales figures for thisproduct listed in the company's annual
report.324,325

GSK

800
700
600
500
400
300
200
100
0

generic priceSpotlight on access issues:

lowest originator priceFor many years, the stavudine (d4T)-containing regimen has played a crucial rolein ART scale-up in resource-limited settings, due to its availability in a fixed-dose
combination and, most importantly, its low cost. d4T remains a widely-used ARV
in first-line regimens.

684

193

161
97

Oct June Dec May Dec Apr Feb June June June June Dec
2001 2002 20022003 2003 2004 2005 2005 2006 2007 20082009

Month/Year

Evolution of the lowest price quoted for eligible developing
countries since 2001:
As of December 2009, there were seven generic sources of
AZT 300mg listed on the WHO List of Prequalified
Medicinal Products and the lowest-priced product on the
List is shown here.

In December 2009, WHO released new recommendations for antiretroviraltherapy for HIV in adults and adolescents. These new recommendations advise
countries to phase out stavudine-based regimens because of its long term
irreversible side effects and to move towards zidovudine or tenofovir (TDF)based first-line regimens.375
For second-line treatment, and if tenofovir has been used in the first-line, AZT in
combination with lamivudine (3TC) is the recommended NRTI backbone, towhich a boosted protease inhibitor (PI) should be added.
Paediatrics AZT is approved for use and is widely used in children.
Generic manufacturers have been developing both double and triple paediatricfixed-dose combinations including AZT. Today, however, there are four paediatric
FDCs containing AZT that are listed on WHO Prequalification List of Medicinal
Product. To give clinicians flexibility in prescribing ARV regimens, there is a needfor a simple adapted formulation of AZT. The Paediatric AIDS Working Group of
WHO has given “important” priority to the development of a 60mg tablet. Today
there is one generic version of AZT 60mg which is prequalified by WHO.326

40 • Médecins Sans Frontières • January 2010 • Untangling the Web of ARV Price Reductions • Please check utw.msfaccess.org

ATAZANAVIR (ATV)
General information

PROTEASE INHIBITORS
Price information: Prices in US$ quoted by companies for eligible developing countries
Bristol-Myers Squibb

Daily dose

• Therapeutic class: protease inhibitor(PI).

Category 1• Indicated for second-line, for adults
and adolescents (WHO 2006 guidelines).50• Originator company and product brand
name: Bristol-Myers Squibb (BMS),
Reyataz.
• First approval by U.S. Food and Drug
Administration (FDA): 20 June 2003.51• Included in the 16th edition of the
WHO Model List of Essential Medicines(EML).52• World sales of originator product for
2008: US$ 1.29 billion; 2007: US$ 1.12
billion; 2006: US$ 931 million; 2005: US$
696 million; 2004: US$ 369 million;
2003: US$ 81 million.53,54,55,56• The basic patent was filed in April 1997
by Novartis and is expected to expire in
April 2017.57 Bristol-Myers Squibb ismanufacturing ATV under licence from
Novartis. BMS also applied for patents on
the crystalline bisulfate salt of ATV in
December 199858 and on a process for
preparing the bisulfate salt and novel
forms in 2005.59

Category 2

see annexes 2 and 7

Eligibility restrictions

Emcure (CF)none
373 (0.341)

ATV 100mg capsule3*

ATV 150mg capsule2*353 (0.484)

431 (0.590)

318 (0.435)

ATV 200mg capsule--(0.602)(0.743)(0.518)*The dose of ATV must be boosted with RTV 100mg once a day.
(CF) The Clinton Foundation has negotiated with thismanufacturer for reduced prices on some formulations forcountries in their consortium. See annex 13 for details.
Products included in the WHO list of Prequalified Medicinal
Products (as of December 2009) are in bold.
Note: BMS second category pricing is provided in South African
Rand (ZAR). These were converted to US$ on the date theprices were received, hence fluctuations in the US$/ZAR rate will
impact these prices.

Spotlight on access issues:
In December 2009, WHO recommended that for second-line therapy,
the preferred protease inhibitors to be taken in combination with
two NRTIs are atazanavir (ATV) boosted with ritonavir (RTV) andlopinavir/ritonavir (LPV/r). Of the two, ATV is the most patientfriendly PI, as it requires the patient to take only two 150mg pills
once a day.375

BMS in February 2006 granted technology transfer and voluntary
licences to two generic manufacturers (Emcure and Aspen) to
manufacture and sell ATV. In February 2008, Emcure received U.S.
FDA tentative approval for the 100mg, 150mg and 200mg ATV
capsules. Under the terms of the licenses, however, sales of theseproducts are royalty-free but are restricted to sub-Saharan Africa.

ATV, like all PIs (with the exception of nelfinavir (NFV)), requires
boosting with RTV. Abbott's monopoly on RTV and the temperaturesensitive nature of the currently available formulation of RTV may
limit the use of this product in the developing world.

BMS has a separate agreement with Emcure that covers India.61
Licensing agreements in India should not be necessary if patent
oppositions are successful. If the patent is granted, the only
alternative for India and other countries will be to use
compulsory licenses to enable unrestricted competition fromgeneric manufacturers, in order to bring prices down and increase
access.

The required addition of RTV as a booster must also be consideredin the final cost of using ATV. As ATV is one of the two PIs
recommended by WHO, there is an urgent need for genericmanufacturers to supply a heat-stable ATV/r fixed-dose combination.
Patents Patent applications related to ATV have been filed by
Novartis and BMS in most developing countries with genericpharmaceutical production capacity, including Brazil, China andIndia. Some of these patents have already been granted in Brazil
and China. In India, where the patent applications are still under
examination, civil society organisations filed a pre-grant opposition
to Novartis's basic patent application on the grounds of lack ofnovelty,60 but the other patent applications warrant additional pregrant oppositions.
In addition, Abbott has filed patent applications on RTV in India
and other developing countries, which, if granted, will block thedevelopment of and access to generic ATV/r fixed-dose
combinations.

BMS's differential pricing structure is limited to sub-Saharan Africa
and low-income countries. This structure leaves middle-income
countries paying more than US$ 1,591 per patient per year, which
is prohibitive for many of these countries.62
Paediatrics In March 2008, ATV was approved for use in children
between six and 18 years of age. In 2008, WHO recommended
early treatment for all HIV-positive children, and children who
have been exposed to nevirapine either through their mother or
through a single dose in a PMTCT programme. WHO recommends
these children should be started on a PI-based regimen.63 Today,
the only option for these children is the LPV/r formulation. To
simplify treatment for all children, there is an urgent need forstudies on ATV to be completed down to infants, and childadapted formulations to be made available.

Médecins Sans Frontières • January 2010 • Untangling the Web of ARV Price Reductions • Please check utw.msfaccess.org • 41

DARUNAVIR (DRV)
General information

PROTEASE INHIBITORS
Price information:
Prices in US$ quoted by companies for eligible developing countries• Therapeutic class: protease inhibitor (PI).
Daily dose

Tibotec• Not currently included in WHO guidelines.
• Indicated for treatment-experienced
patients, such as those with HIV-1 strains
resistant to more than one protease inhibitor(adults). It is also indicated in developed
countries for treatment-naïve patients.65

see annex 2

Eligibility restrictions
DRV 300mg tablet

4*1095 (0.750)* The dose of DVR must be boosted with RTV 100mg twice a day.

• Originator company and product name:Tibotec (a division of Johnson&Johnson),Prezista.
• First approved by the U.S. Food and Drug
Administration (FDA): 23 June 2006.66• Not included in the WHO Model List of
Essential Medicines (EML).67• Darunavir basic patent applied for by Searleand Monsanto in August 1993,68 and due toexpire in 2013. Subsequently, NIH and the
University of Illinois applied for patents more
specifically related to darunavir in 199969 andlicensed them to Tibotec for development.70
Tibotec later applied for patents related to
improved forms and combinations ofdarunavir.71,72

Spotlight on access issues:

available formulation of RTV may limit the use of thisproduct in the developing world.

In December 2009, WHO released new recommendations
which for the first time call for the need of third-line therapy.
As many studies are ongoing, drugs likely to have anti-HIV
activity in third-line regimens are boosted darunavir,
etravirine and raltegravir.375

The required addition of RTV as a booster must also be
considered in the final cost of using DRV.

Tibotec signed a royalty-free, non-exclusive license agreementwith South African firm Aspen on 4 April 2007. This grants
Aspen the right to register, package and distribute darunavir(DRV) in sub-Saharan Africa.73 This agreement excludes otherlow- and middle-income countries, for which the price paid in
wealthy countries, at over US$ 12,000 per patient per year, isprohibitive.74

Patents Even though basic patents related to DRV could not
be applied for in India before 1995, Tibotec has applied forseveral patents in India related to new forms andcombinations of DRV with tenofovir (TDF) and ritonavir (RTV),
some of which have been opposed by generic manufacturers.
Most of these patent applications remain under review at the
Indian patent office. The Indian patent office recently rejected
the DRV patent related to pseudopolymorph (which would
have been due to expire in 2023). A voluntary license for the
DRV pseudopolymorph has been granted in South Africa.

In Brazil, DRV was included in the government's guidelines in
2008, but at US$ 8,018 per patient per year, it is very
expensive.

In addition, a number of patents related to DRV exist in
Brazil.

DRV, like all PIs (with the exception of nelfinavir (NFV)),
requires boosting with ritonavir (RTV). Abbott's monopoly on
RTV and the temperature-sensitive nature of the currently-

Paediatrics In December 2008, DRV was approved for use inchildren between six and 18 years of age. Paediatricformulations are available, but Tibotec has not provided priceinformation for those products.

42 • Médecins Sans Frontières • January 2010 • Untangling the Web of ARV Price Reductions • Please check utw.msfaccess.org

FOSAMPRENAVIR (FPV or f-APV)
General information• Therapeutic class: protease inhibitor (PI).
• Indicated for second-line, for adults (WHO2006 guidelines)129.
• Originator company and product brand
name: GlaxoSmithKline and Vertex
Pharmaceuticals, Lexiva. In April 2009, Pfizer
and GSK jointly announced the creation of
ViiV, a new joint venture focusing solely on
the R&D and commercialisationof HIV medicines.
• First approved by the U.S. Food and Drug
Administration(FDA): 20 October 2003.130• Not included in the WHO Model List of
Essential Medicines (EML).131• Basic patent applied for by Vertex
Pharmaceuticals in March 1998,132 and due toexpire in 2018. Fosamprenavir, a phosphateester prodrug of amprenavir,133 was developed
and launched by GSK, under license from
Vertex.

PROTEASE INHIBITORS

Price information: Prices in US$ quoted by companies for eligible developing countries
Daily dose
Eligibility restrictions

GSK
see annex 2

FPV 700mg tablet

2*

1222 (1.674)

FPV 50mg/ml suspension

12ml

648 (0.148/ml)*The dose of FPV must be boosted with RTV 100mg twice a day.

Spotlight on access issues:
In December 2009, WHO recommended that for second-line
therapy, the preferred protease inhibitors to be taken in
combination with two NRTIs are atazanavir (ATV) boosted
with ritonavir (RTV) and lopinavir/ritonavir (LPV/r). As
fosamprenavir (FPV) was not identified as one of the priority
products, its use will be limited in the developing world.375
While FPV/r based regimens show good antiviral efficacy andare generally well tolerated in therapy-naïve patients, theexperience of this drug in developed countries is limited andlittle comparative data is available in treatment-experienced
patients.135
FPV, like all PIs (with the exception of nelfinavir (NFV)),
requires boosting with ritonavir (RTV). Abbott's monopoly on
RTV and the temperature-sensitive nature of the currentlyavailable formulation of RTV may limit the use of thisproduct in the developing world.

The required addition of RTV as a booster must also be
considered in the final cost of using FPV.
Patents Patent applications have been filed for in many
developing countries. In Brazil, the basic patent has been
rejected by the patent office, but there is a patent on the
calcium salt that will expire in 2019. In China, South Africa
and OAPI countries,134 both of these patents have been
granted. In India, patent applications on the FPV salts,
including calcium, have been filed and are pending review
by the patent office.
There are no generic formulations of this product available
today.
Paediatrics FPV is approved for use in children and apaediatric formulation is available.

Médecins Sans Frontières • January 2010 • Untangling the Web of ARV Price Reductions • Please check utw.msfaccess.org • 43

INDINAVIR (IDV)
General information

PROTEASE INHIBITORS
Price information: Prices in US$ quoted by companies for eligible developing countries
Merck• Therapeutic class: protease inhibitor (PI).
• Indicated for second-line for adults (WHO2006 guidelines)136• Originator company and product brand
name: Merck, Crixivan.

Daily dose Category 1
Eligibility restrictions
IDV 400mg capsule

Cipla

Ranbaxy

None

None

None

Category 2

see annexes 2 and 10
4*

Aurobindo

394 (0.270) 686 (0.470) 365 (0.250) 422 (0.289) 426 (0.292)*The dose of IDV must be boosted with RTV 100mg twice a day.
Products included in the WHO list of Prequalified Medicinal Products (as of December 2009) are in BOLD in the table.

• First approval by U.S. Food and Drug
Administration (FDA): March 1996.137• Included in the 16th edition of the WHO
Model List of Essential Medicines (EML)138

Spotlight on access issues:• There are no sales figures for this productlisted in the company annual report.

In December 2009, WHO recommended that for second-line
therapy, the preferred protease inhibitors to be taken in
combination with two NRTIs are atazanavir (ATV) boosted withritonavir (RTV) and lopinavir/ritonavir (LPV/r).64 As IDV was not
identified as one of the priority products, its use will be limitedin the developing world.375• The basic patent was filed for by Merck in1991 and is due to expire in 2012 incountries granting 20-year patents.139

The main concern was that at a standard dose of 800mg IDV
with 100mg ritonavir (RTV) twice a day, it was less well tolerated
than other PIs, particularly in hot climates.141 There have beensome small studies to support a lower dose of IDV + RTV 400 +100mg twice a day with the aim to reduce toxicity. The U.S. FDA
has also approved the use of IDV at 800mg every eight hours
without RTV.

44 • Médecins Sans Frontières • January 2010 • Untangling the Web of ARV Price Reductions • Please check utw.msfaccess.org

IDV, like all PIs (with the exception of nelfinavir (NFV)), requires
boosting with ritonavir (RTV). Abbott's monopoly on RTV and thetemperature-sensitive nature of the currently-available formulationof RTV may limit the use of this product in the developing world.
The required addition of RTV as a booster must also be
considered in the final cost of using IDV. Some genericmanufacturers have stopped production of IDV, or only
manufacture it for specific orders, because of a decrease indemand for this product.
Paediatrics The optimal dosing regimen for the use of IDV in
paediatric patients has not been established and no paediatricformulation exists.140

LOPINAVIR/RITONAVIR (LPV/r)
General information

PROTEASE INHIBITORS
Price information: Prices in US$ quoted by companies for eligible developing countries
Abbott• Therapeutic class: boosted Protease
Inhibitor (PI) in a double fixed-dose
combination.
• Indicated for second-line, for adults,
adolescents and children (WHO 2006
guidelines).172,173• First approval by U.S. Food and Drug
Administration (FDA): September 2000 (softgel capsules); October 2005 (heat-stable
tablets).174

Daily dose

Category 1

see annexes 2 and 8

Eligibility restrictions
LPV/r 133/33mg
soft gel capsule

Category 2

6500 (0.228)1000 (0.457)

LPV/r 200/50mg
tablet (heat-stable)4

440 (0.301)

1000 (0.685)

LPV/r 80/20mg/ml
oral solution

4ml

176 (0.121/ml)

400 (0.274/ml)

3165 (0.151)

376 (0.343)

LPV/r 100/25mg
tablet (heat-stable)

Aurobindo
(CF)

Cipla
(CF)

Matrix
(CF)

None

None

None

1218 (0.556)
511 (0.350)

329 (0.300)

486 (0.333)

486 (0.333)

228 (0.208)• Originator company and product brand
name: Abbott Laboratories, Kaletra, Aluvia.

(CF) The Clinton Foundation has negotiated with this manufacturer for reduced prices on some formulations for countries in theirconsortium. See annex 13 for details.

• Included in the 16th edition of the WHO
Model List of Essential Medicines (EML).175

Products included in the WHO List of Prequalified Medicinal Products (as of December 2009) are in bold.

• Most patents related to ritonavir (RTV) also
cover LPV/r. The basic patent related to LPV
was applied for by Abbott in 1996.178• In addition, Abbott applied for patents more
specifically related to LPV/r soft-gel capsulesin 1997179 which are due to expire in 2017. An
application for a patent on the heat-stable
tablet formulation was also filed in 2004,180
which, if granted, would run until 2024.

generic price (133/33mg non heat-stable)
lowest originator price (133/33mg or 200/50mg)
generic price (200/50mg heat-stable)

LPV/rlowest originator price (200/50mg heat-stable)

US$ ppy• World sales of originator product: 2008:
US$ 1.47 billion; 2007: US$ 1.32 billion;
2004: US$ 897 million; 2003: US$ 754
million; 2002: US$ 551 million; 2001: US$ 292
million.176,177

4500
4000
3500
3000
2500
2000
1500
1000
500
0

3833

Evolution of the lowest quoted price for eligible
developing countries since 2002:
As of December 2009, there were two generic sourcesof lopinavir/ritonavir 200/50mg listed on the WHO Listof Prequalified Medicinal Products. The lowest
available generic price for both the heat-stable tablet
and soft-gel capsule are considered for the graph.
The generic price has decreased by 53% since 2007.

1024
1034
500

500

1218
500
486
440

Jun Dec May Dec Apr Feb June June June June Dec
2002 2002 2003 2003 2004 2005 2005 2006 2007 2008 2009

Month/Year

Médecins Sans Frontières • January 2010 • Untangling the Web of ARV Price Reductions • Please check utw.msfaccess.org • 45

LOPINAVIR/RITONAVIR (LPV/r)

PROTEASE INHIBITORS

Spotlight on access issues:
In December 2009, WHO recommended that for second-line therapy, the preferred
protease inhibitors to be taken in combination with two NRTIs are atazanavir (ATV)
boosted with ritonavir (RTV) and lopinavir/ritonavir (LPV/r).375

India.182 Thailand faced fierce criticism from developed countries and multinational
pharmaceutical companies and Abbott's response was to withdraw all registration
applications in Thailand for its new products, including the heat-stable LPV/r.
Thailand today imports generic LPV/r from India for US$ 748 ppy.183

The heat-stable formulation of LPV/r manufactured by Abbott and Indian genericcompanies (Aurobindo, Cipla, Matrix) is now marketed in developing countries. In
comparison to the older, soft-gel capsule formulation, the new formulation has alower pill count (reducing the burden from six to four pills per day), there is noneed for refrigeration, and there are no dietary restrictions.

In response to Thailand's compulsory license, Abbott reduced the price for 40
middle-income countries for both the soft gel and the heat-stable version to
US$ 1000 ppy, including Brazil which at the time was paying US$ 1,380.373
Paediatrics LPV/r is approved for use in children.

The entry of generic manufacturers is having a positive effect on the market, andprices are declining. The Clinton Foundation's most recent announcement has some
generic manufacturers offering prices of US$ 470 ppy. For the first time, the quoted
generic price is lower than the originator price for this fixed-dose combination.
Since the initial online publication of Untangling the Web in December 2009, Abbott
has indicated a price decrease for LPV/r 200/50mg from US$ 500 to US$ 440 ppy,
bringing the price below that of generic manufacturers.
Patents In India, Abbott has applied for several patents on the solid dosage
formulation and polymorph forms of lopinavir (LPV), ritonavir (RTV) and on theheat-stable combination of LPV/r, a number of which have been opposed by civilsociety organisations181 and generic companies. Following a pre-grant opposition to
the application related to the soft-gel formulation of LPV/r, the company withdrew
the application. Other oppositions are pending decisions by the Indian patentoffice.
If one of these patent applications is granted, current generic competition, which isbringing prices substantially down as demand increases, will be under threat.
In Thailand, where Abbott holds patents, the price of LPV/r was US$ 2,200 per
patient per year (ppy) in 2007. In January 2007, the Ministry of Public Health issued
a compulsory license to import more affordable generic versions of the drug from

In early 2007, Abbott released a heat-stable paediatric tablet. While this new
formulation is welcome, it does not help the youngest patients, as the tablet is15mm long and cannot be crushed, leaving this formulation unsuitable for children
who cannot swallow tablets.
The alternative for these small children is a solution that requires refrigeration until
dispensing, after which it must be stored below 25°C for no more than six weeks.
Furthermore, the solution consists of 42% alcohol and has a very unpleasant taste.
A heat-stable sprinkle in a paediatric dose is under development by genericcompanies.
Today there are two generic sources of heat-stable LPV/r 100/25mg that appear on
the WHO List of Prequalified Medicinal Products.
Recent changes in WHO guidelines recommending that all HIV-positive children
under one year of age start ARV therapy as soon as possible regardless of clinicalstate, combined with the recommendation to start all children exposed tonevirapine on a PI-based regimen, should result in an increased demand for thiscombination for very young children.
There is an urgent need for a more adapted formulation for young children.

46 • Médecins Sans Frontières • January 2010 • Untangling the Web of ARV Price Reductions • Please check utw.msfaccess.org

NELFINAVIR (NFV)
General information

PROTEASE INHIBITORS
Price information: Prices in US$ quoted by companies for eligible developing countries
Cipla

Roche
• Therapeutic class: protease inhibitor (PI).
• Indicated only for second-line in adults,
adolescents and children (WHO 2006
guidelines).194,195• Originator company and product brand
name: Roche, Viracept.
• First approval by U.S. Food and Drug
Administration (FDA): 14 March 1997.196

Daily dose

Category 2

Category 1

see annex 2

Eligibility restrictions

None

NFV 250mg tablet

10

1612 (0.442)

2501 (0.685)

NFV 50mg/g oral
powder24g

2189 (0.250/g)

2533 (0.289/g)

945 (0.259)

Products included in the WHO list of Prequalified Medicinal Products (as of December 2009) arein BOLD in the table.

• Deleted from the 16th edition of the WHO
Model List of Essential Medicines (EML).197• World sales of originator product: 2004:
US$ 259 million. After 2004, there are nosales figures listed in the company's annual
report.198

NFV 250mg capsule

Evolution of the lowest price quoted for eligible
developing countries since 2001:

generic pricelowest originator priceAs of December 2009, there were no WHO
prequalified generic sources of NFV. The lowest
available generic price is therefore shown here.

3139

3000
2500
US$ ppy• Basic patent applied for in 1994 by Agouron
Pharmaceuticals Inc.,199 and due to expire in
2014. Agouron Pharmaceuticals is now asubsidiary of Pfizer. NFV was developed by
Agouron as part of a joint venture with Japan
Tobacco, Inc. NFV is supplied by Rocheoutside U.S., Canada and Japan.200

3500

2924

2000

1612

1500
1000

945

500

Roche quotes prices in Swiss Francs (CHF), whichhave been converted to US$ on the date received.
Fluctuations in the US$/CHF rate will thus have an
impact on prices used in the graph.

0
Oct June Dec May Dec April Feb June June June June Dec
2001 2002 2002 2003 2003 2004 2005 2005 2006 2007 2008 2009

Month/Year

Médecins Sans Frontières • January 2010 • Untangling the Web of ARV Price Reductions • Please check utw.msfaccess.org • 47

NELFINAVIR (NFV)

PROTEASE INHIBITORS

Spotlight on access issues:
Nelfinavir (NFV) is the only protease inhibitor (PI) that does
not require boosting with ritonavir (RTV).
The large pill burden (10 tablets a day for an adult) and thehigh price make it a less-desirable option when selecting aPI. However, the fact that it does not need to be given with
RTV means that the heat-sensitive nature of the current RTV
formulation does not need to be a consideration. This had
made the drug an attractive option for some developing
countries in the past.
In June 2007, Roche recalled all batches of NFV due to highlevels of Ethyl Methane Sulphonate (EMS), a by-product ofthe manufacturing process and a known carcinogen inanimals. Roche's marketing licence for NFV was suspended inEurope and the WHO prequalification project temporarilysuspended the product. In September 2007, the suspensions
were lifted and marketing licences reinstated.201
As a result of the recall, many patients were changed toanother PI. It is unknown if there will continue to be demand

for the NFV formulation in the future. NFV was also deleted
from the 16th edition of the WHO Model List of Essential
Medicines (EML).
Patents Even though patents could not be applied for in
India prior to 1995, Agouron applied for patents on NFV inmany other developing countries. This factor contributes tothe high price of the drug, together with the small demand.
The recall of Roche's NFV in 2007 highlights the risk
associated with relying on a single producer for a medicine.
Paediatrics The use of NFV oral powder in children is
extremely complex. To obtain the correct dose for a 10kg
child, 12g of the oral powder must be mixed with water.
Access to clean, safe water is often not ensured in all
developing countries.
Not only is the paediatric NFV formulation ill-adapted, but its
price remains prohibitive, as is the case with other proteaseinhibitors.

48 • Médecins Sans Frontières • January 2010 • Untangling the Web of ARV Price Reductions • Please check utw.msfaccess.org

RITONAVIR (r or RTV)
General information

PROTEASE INHIBITORS
Price information: Prices in US$ quoted by companies for eligible developing countries
Daily dose usedas booster• Therapeutic class: protease inhibitor (PI).
• Indicated for second-line as a booster, foradults, adolescents and children (WHO 2006
guidelines).220,221• Originator company and product brand
name: Abbott Laboratories, Norvir.
• First approval by U.S. Food and Drug
Administration (FDA): March 1996 for the oral
solution and 29 June 1999 for capsules.222

Eligibility restrictions

AbbottCipla

Stridessee annexes 2 and 8

None

None

313 (0.429)

219 (0.300)

RTV 100mg capsule2

83 (0.114)

RTV 80mg/ml oral
solution--(0.093/ml)

Products included in the WHO list of Prequalified Medicinal Products (as of December 2009) are in BOLD
in the table.

• Included in the 16th edition of the WHO
Model List of Essential Medicines (EML).223• World sales of originator product: 2004:
US$ 194 million; 2003: US$ 93 million; and2002: US$ 122 million.224

Evolution of the lowest price quoted for
eligible developing countries since 2001:

Ritonavir 100mg capsule (non heat-stable)
generic pricelowest originator price

US$ ppy• Basic patent applied for by Abbott in
1993.225,226,227 These are due to expire in
2018-2019.

4000
3500 3504
3000
2500
2000
1500
1000 650
5000

As of December 2009, there was no
generic source of RTV listed on the
WHO List of Prequalified Medicinal
Products. The lowest available genericprice is therefore shown here.

219
83

Oct June Dec May Dec April Feb June June June June Dec
2001 2002 2002 2003 2003 2004 2005 2005 2006 2007 2008 2009

Month/Year

Médecins Sans Frontières • January 2010 • Untangling the Web of ARV Price Reductions • Please check utw.msfaccess.org • 49

RITONAVIR (r or RTV)PROTEASE INHIBITORS

Spotlight on access issues:
Ritonavir (RTV) is of crucial importance for the scaling-up andmanagement of second-line treatment, as all proteaseinhibitors, (with the exception of nelfinavir (NFV)), must beboosted with this drug. RTV today is only available from
Abbott as a soft-gel capsule that requires refrigeration. The
heat-sensitive nature of the formulation makes it extremely
ill-adapted for use in developing countries.

and divisional applications on new forms of RTV are
pending before the Indian patent office. A pre-grant
opposition to an application related to a polymorph of RTV
was filed by civil society organisations in India in September
2006.228

Abbott has developed a heat-stable fixed-dose combinationof lopinavir and RTV (LPV/r) that was approved in the U.S. in
2005, but today the heat-stable RTV alone is not yet
available. Abbott has filed for registration of the heat-stableversion of RTV with U.S. FDA and EMEA. The development
and marketing of a heat-stable RTV formulation would becritical to eliminating the heat-stable boosted PI monopolythat Abbott currently has with LPV/r.

The outcome of this opposition will be crucial to the
management of PI-based second-line treatment.

Patents Although the basic patent disclosing RTV could not
be applied for in India, Abbott's original patent applications

The decision of the Indian patent office is pending.

Paediatrics RTV is approved for use in children and there is aliquid formulation available. The solution has a bitter
aftertaste and is 43% alcohol, and hence not adapted forchildren.
The Paediatric Antiretroviral Working Group of WHO has given“important” priority to the development of a 25mg heatstable RTV tablet.229

50 • Médecins Sans Frontières • January 2010 • Untangling the Web of ARV Price Reductions • Please check utw.msfaccess.org

SAQUINAVIR (SQV)
General information

PROTEASE INHIBITORS
Price information: Prices in US$ quoted by companies for eligible developing countries• Indicated for second-line, to be usedboosted by ritonavir, for adults, adolescentsand children (WHO 2006 guidelines).230• Originator company and product brand
name: Roche, Invirase.
• First approval by U.S. Food and Drug
Administration (FDA): December 1995.231

Roche

Daily dose

• Therapeutic class: protease inhibitor (PI).

Category 1

Cipla
Category 2

see annex 2

Eligibility restrictions
SQV 200mg hard
capsule10*1249 (0.342)

2501 (0.685)

SQV 500mg tablet

4*1146 (0.785)

2499 (1.712)

None1621 (0.444)* The dose of SQV must be boosted with RTV 100mg twice a day.
Products included in the WHO list of Prequalified Medicinal Products (as of December 2009) are in BOLD in the table.

• Included in the 16th edition of the WHO
Model List of Essential Medicines (EML).232• The basic patent was applied for by Rochein 1990233 and is due to expire in 2010.
SQV 200mg hard capsule

Evolution of the lowest price quoted for eligible
developing countries since 2001:

generic pricelowest originator price

US$ ppy• The patent related to oral dosage form wasapplied by Roche in 2004 and is due toexpire in 2024.234

2000
1800
1600
1400
1200
1000
800
600
400
200
0

1342

1621

1335

As of December 2009, there was no generic source of
SQV listed on the WHO List of Prequalified Medicinal
Products. The lowest available generic price is therefore
shown here.

1249

Oct Jun Dec May Dec Apr Feb June June June June Dec
2001 2002 2002 2003 2003 2004 2005 2005 2006 2007 2008 2009

Month/Year

Médecins Sans Frontières • January 2010 • Untangling the Web of ARV Price Reductions • Please check utw.msfaccess.org • 51

Spotlight on access issues:
In December 2009, WHO recommended that for second-line
therapy, the preferred protease inhibitors to be taken in
combination with two NRTIs are atazanavir (ATV) boosted
with ritonavir (RTV) and lopinavir/ritonavir (LPV/r). As
saquinavir (SQV) was not identified as one of the priority
products, its use in the developing world will be limited.375
SQV/r appears to be slightly less potent than the otherboosted PIs and in the original formulation has a high pillcount (10 capsules).235
In 2004, Roche marketed in the U.S. a 500mg tablet of SQVthat reduced the pill count from 10 tablets to four. While thisnew formulation should improve adherence, it is only
registered and marketed in selected developing countries.
As with other protease inhibitors, SQV's high price continues
to be a barrier. Solid competition and economies of scale
among producers are minimal, as its use is fairly limited.

SQV, like all PIs (with the exception of nelfinavir (NFV)),
requires boosting with ritonavir (RTV). Abbott's monopoly on
RTV and the temperature-sensitive nature of the currentlyavailable formulation of RTV may limit the use of this productin the developing world.
The required addition of RTV as a booster must also be
considered in the final cost of using SQV.
Patents The basic patent was rejected in Brazil. But thepatent related to the oral dosage form was granted in Indiaand in OAPI countries.
Paediatrics SQV has not been approved for use in children in
the U.S. and there is no paediatric formulation available.

52 • Médecins Sans Frontières • January 2010 • Untangling the Web of ARV Price Reductions • Please check utw.msfaccess.org

TIPRANAVIR (TPV)
General information• Therapeutic class: Protease Inhibitor (PI).

PROTEASE INHIBITORS
Price information:
Prices in US$ quoted by companies for eligible developing countries
No reduced pricing available for developing countries.

• Not currently included in WHO guidelines.
• TPV is indicated for combination treatment
of HIV-1 infected adult patients who aretreatment-experienced and infected with HIV-1
strains resistant to more than one proteaseinhibitor.312• Originator company and product brand
name: Boehringer Ingelheim, Aptivus.
• First approved by the U.S. Food and Drug
Administration (FDA): 23 June 2005.
• Not included in the WHO Model List of
Essential Medicines (EML).313• Basic patent applied for by Upjohn in May
1995,314 and due to expire in 2015. In 1998,
Pharmacia & Upjohn applied for additional
patents related to pharmaceutical formulations
suitable for the oral administration of TPV.315,316
In January 2000, BI acquired worldwide rights
for TPV.

Spotlight on access issues:
In December 2009, WHO recommended that for second-line
therapy, the preferred protease inhibitors to be taken in
combination with two NRTIs are atazanavir (ATV) boosted
with ritonavir (RTV) and lopinavir/ritonavir (LPV/r). As
tipranavir (TPV) was not identified as one of the priority
products, its use in the developing world will be limited.375
Boehringer Ingelheim was invited to contribute a price forthis publication and has communicated that tipranavir (TPV)
is available through its Compassionate Use Program and thatthe company is currently filing for registration in various
countries.
TPV, like all PIs (with the exception of nelfinavir (NFV)),
requires boosting with ritonavir (RTV). Abbott's monopoly on
RTV and the temperature sensitivity of current formulations of
RTV may limit the use of this product in the developingworld. TPV capsules also require refrigeration until
dispensing.
The required addition of RTV as a booster must also be
considered in the final cost of using TPV.

Patents TPV patents have been filed for widely in developing
countries with generic production capacity, such as Brazil. In
Brazil, where the patent applications are under review, thedrug regulatory agency (ANVISA), which has to give “priorconsent” for any patent application related to a medicine,
has advised for the rejection of the basic patentapplication.317
In early 2007, civil society expressed concerns over thedelays to the registration procedure of TPV in Brazil (themedicine had been tested in Brazilian patients in 14 research
centres since February 2004, but the drug was not actuallyregistered in the country). After considerable civil society
pressure, the registration was eventually filed with ANVISA at
the end of February 2008, almost three years after U.S. FDA
and EMEA approvals. The intervention by Brazilian civilsociety was partly based in response to suspicions that
Boeringer Ingelheim did not want to register the product in
the country, unless they had the guarantee that the patent
would be granted by the patent office.318,319
Paediatrics TPV is currently approved for use in children fromtwo years of age and older, and a paediatric oral solution
exists.

Médecins Sans Frontières • January 2010 • Untangling the Web of ARV Price Reductions • Please check utw.msfaccess.org • 53

ABACAVIR/LAMIVUDINE (ABC/3TC)• Therapeutic class: double fixed-dose
combination of two NRTIs.
• Indicated for first-line for adults, adolescentsand children.39,40• Originator company and product brand
name: GlaxoSmithKline (GSK), Kivexa (EU),
Epzicom (U.S.). In April 2009, Pfizer and GSK
jointly announced the creation of ViiV, a new
joint venture focusing solely on the R&D andcommercialisation of HIV medicines.
• First approval by U.S. Food and Drug
Administration (FDA): August 2004.41• The WHO Expert Committee on the
Selection and Use of Essential Medicines
recommends and endorses the use of fixeddose combinations and the development ofappropriate new fixed-dose combinations.42• World sales of originator product: 2008:
US$ 721 million; 2007: US$ 641 million; 2006:
US$ 475 million; 2005: US$ 233 million.43,44,45,46• Most patents on abacavir (ABC) or
lamivudine (3TC) also affect this combination.
In addition, GSK applied for patents more
specifically related to the combination.47 The
patent expiry dates related to thiscombination are 2016 in the U.S. and 2019
in EU.48
For information on the individual ARVs
contained in this fixed-dose combination
please refer to the individual drug productcards.

Price information: Prices in US$ quoted by companies for eligible developing countries
Daily dose
Eligibility restrictions
ABC/3TC 600/300mg tablet

1

ABC/3TC 60/30mg tablet

4

GSK

Aurobindo (CF)Cipla

Matrix (CF)see annex 2

None

None

None

484 (1.326)

157 (0.429)

152 (0.417)

194 (0.133)

244 (0.167)(CF) The Clinton Foundation has negotiated with this manufacturer for reduced prices on some formulations forcountries in their consortium. See Annex 13 for details.
Products included in the WHO List of Prequalified Medicinal Products (as of December 2009) are in BOLD in the table.

ABC/3TC 600/300mg tablet

generic pricelowest originator price

US$ ppy

General information

FIXED-DOSE COMBINATIONS & CO-PACKS

800
700 678
600
500
400
300
255
200
100
0
June 2006

484

157
June 2007

June 2008

Spotlight on access issues:
Patents GSK could not apply for basic patents related
to abacavir (ABC) or lamivudine (3TC) in somedeveloping countries such as India, that did not grant
patents on pharmaceutical products at the time. This
allowed Indian drug manufacturers to develop genericversions of each medicine, and of the combination of
the two.
However, GlaxoSmithKline widely applied for patents inother developing countries where possible.

Dec 2009

Month/Year

Evolution of the lowest price quoted for eligible developing countries
since 2006:
As of December 2009, there was one generic source of ABC/3TC
600/300mg listed on the WHO List of Prequalified Medicinal Products
and the lowest-priced product on the List is shown here.
There has been a decrease of 38% in the generic price since 2006.

54 • Médecins Sans Frontières • January 2010 • Untangling the Web of ARV Price Reductions • Please check utw.msfaccess.org

Paediatrics The Paediatric Antiretroviral Working Group
at WHO classed the development of a paediatricformulation of ABC/3TC fixed-dose combination a “high”
priority.49
Yet GSK does not produce a fixed-dose combination ofthese drugs for children – even though the same is
produced for adults. Nevertheless for children who needthis combination, there are now two generic sources
which appear on the WHO List of Prequalified Medicinal
Products.

LAMIVUDINE/STAVUDINE (3TC/d4T)
General information

FIXED-DOSE COMBINATIONS & CO-PACKS

Price information: Prices in US$ quoted by companies for eligible developing countries
Daily
dose

• Therapeutic class: double fixed-dose
combination of two NRTIs.

• WHO updated the 2006 guidelines torecommend a reduction in dose of d4T from40 to 30mg for all weight categories ofpatients.155• The WHO Expert Committee on the
Selection and Use of Essential Medicines
recommends and endorses the use of fixeddose combinations and the development ofappropriate new fixed-dose combinations.156• Not included in the WHO Model List of
Essential Medicines (EML) as a fixed-dose
combination, but the individual drugs areincluded in the EML.157• Individual patents on lamivudine (3TC) or
stavudine (d4T) also affect this combination.
In addition, other patents may have been
applied for more specifically related to theuse of both medicines in combination, or to
the FDC.
For information on the individual ARVs
contained in this fixed-dose combination,please refer to the individual drug profiles.

Eligibility restrictions

Cipla
(CF)

Matrix(CF)

Ranbaxy(CF)

Strides
(CF)

None

None

None

None

None

53 (0.072)

50 (0.068)

49 (0.067)

55 (0.075)

46 (0.063)

3TC/d4T 150/30mg tablet

2

3TC/d4T 30/6mg
dispersible tablet

4

47 (0.032)

3TC/d4T 60/12mg
dispersible tablet

2

40 (0.055)(CF) The Clinton Foundation has negotiated with this manufacturer for reduced prices on some formulations for countries in theirconsortium. See Annex 13 for details.
Products included in the WHO List of Prequalified Medicinal Products (as of December 2009) are in BOLD in the table.

3TC/d4T 150/30mg tablet

Evolution of the lowest price quoted for eligible developing
countries since 2003:

generic pricelowest originator price

200

183

As of December 2009, there were six generic sources of 3TC/d4T
150/30mg on the WHO List of Prequalified Medicinal Products
and the lowest-priced product on the List is shown here.

150
US$ ppy• Indicated for first-line for adults,
adolescents and children (WHO 2006
guidelines).153,154

Aurobindo(CF)112
100 125

As there is no originator fixed-dose combination, the price shownfor the originator is for the combination of the two individual
originator products.

50
46
0
May
2003

Dec
2003

Apr
2004

Feb
2005

June
2005

June
2006

June
2007

June
2008

Dec
2009

There has been a 39% decrease in the originator price and a
63% decrease in generic price since 2003.

Month/Year

Médecins Sans Frontières • January 2010 • Untangling the Web of ARV Price Reductions • Please check utw.msfaccess.org • 55

LAMIVUDINE/STAVUDINE (3TC/d4T)

FIXED-DOSE COMBINATIONS & CO-PACKS

Spotlight on access issues:This combination has been an important formulation that has
fostered treatment scale-up in resource-limited settings.
In December 2009, WHO released new recommendations for
antiretroviral therapy for HIV in adults and adolescents.
These new recommendations advise countries to phase out
stavudine-based regimens because of their long-term
irreversible side effects and to move towards zidovudine(AZT) or tenofovir- (TDF) based first-line regimens. We cantherefore expect to see a decrease in the use of thisformulation in the future.375

Paediatrics The most commonly used first-line regimens forchildren today are either 3TC+d4T+NVP or AZT+3TC+NVP. With
both of these regimens, there is a need to start nevirapine(NVP) at a lower dose for the first two weeks to minimise
the side effects.
The Paediatric Antiretroviral Working Group at WHO classed
the development of a paediatric formulation of 3TC/d4T fixeddose combination an “urgent” priority.368 For children who
need this double 3TC/d4T FDC, there are two genericproducts which are listed on the WHO List of Prequalified
Medicinal Products.

Patents Generic companies in certain developing countries
were able to develop these fixed-dose combinations because
patents on the individual products did not exist.
The FDC is not available in developed countries or incountries such as China, however, where one or both
medicines is under patent.

56 • Médecins Sans Frontières • January 2010 • Untangling the Web of ARV Price Reductions • Please check utw.msfaccess.org

LAMIVUDINE/STAVUDINE/NEVIRAPINE (3TC/d4T/NVP)
General information

FIXED-DOSE COMBINATIONS & CO-PACKS

Price information: Prices in US$ quoted by companies for eligible developing countries
Aurobindo (CF) Cipla (CF)

Daily
dose

• Therapeutic class: triple fixed-dose
combination of two NRTIs and a NNRTI.
Eligibility restrictions• Indicated for first-line for adults,
adolescents and children (WHO 2006
guidelines).164,165• WHO updated the 2006 guidelines torecommend a reduction in dose of d4T from40 to 30mg for all weight categories ofpatients.166

EmcureMatrix (CF) Ranbaxy

Strides (CF)

None

None

None

None

None

None

82 (0.113)

80 (0.110)

88 (0.121)

85 (0.117)

93 (0.128)

91 (0.125)

3TC/d4T/NVP 150/30/200mg tablet

2

3TC/d4T/NVP 30/6/50mg dispersible tablet

4

61 (0.042)

3TC/d4T/NVP 60/12/100mg dispersible tablet

2

55 (0.076)(CF) The Clinton Foundation has negotiated with this manufacturer for reduced prices on some formulations for countries in theirconsortium. See Annex 13 for details.
Products included in the WHO List of Prequalified Medicinal Products (as of December 2009) are in BOLD in the table.

• Included in the 16th edition of the WHO
Model List of Essential Medicines (EML) – only
the d4T 30mg presentation.167• The WHO Expert Committee on the
Selection and Use of Essential Medicines
recommends and endorses the use of fixeddose combinations and the development ofappropriate new fixed-dose combinations.168

3TC/d4T/NVP 150/30/200mg tablet

generic price

Evolution of the lowest price quoted for eligible
developing countries since 2002:

lowest originator price

For information on the individual ARVs
contained in this fixed-dose combination
please refer to the individual drug profiles.

700

As of December 2009, there were eight genericsources of 3TC/d4T/NVP 150/30/200mg listed in the
WHO List of Prequalified Medicinal Products andthe lowest-priced product on the List is shown here.

615

600
500
US$ ppy• Individual patents on lamivudine (3TC),
stavudine (d4T) or nevirapine (NVP) also
affect this combination. In addition, otherpatents may have been applied for more
specifically relating to the use of the
medicines in combination or to the fixed-dose
combination. Cipla first developed the FDC
and applied for patents in several Africancountries.

400
300

331
281

200
80

100
0

June Dec May Dec Apr Feb June June June Dec
2002 2002 2003 2003 2004 2005 2005 2006 2007 2009

As there is no originator fixed-dose combination, theprice shown for the originator is for the combinationof the three individual originator products.
There has been a decrease of 72% in the genericprice since 2002.

Month/Year

Médecins Sans Frontières • January 2010 • Untangling the Web of ARV Price Reductions • Please check utw.msfaccess.org • 57

LAMIVUDINE/STAVUDINE/NEVIRAPINE (3TC/d4T/NVP)

FIXED-DOSE COMBINATIONS & CO-PACKS

Spotlight on access issues:This combination has played a major role in the scaling upof antiretroviral therapy in the developing world and remains
the most-commonly prescribed therapy in resource-limited
settings for first-line treatment in adults.
In December 2009, WHO released new recommendations for
antiretroviral therapy for HIV in adults and adolescents.
These new recommendations advise countries to phase out
stavudine-based regimens because of its long-term
irreversible side effects and develop a plan to move towards
zidovudine (AZT) or tenofovir (TDF)-based first-line regimens.
We can therefore expect to see a decrease in the use of thisformulation in the future.375
Patents Cipla was able to develop this combination because
none of the individual components were patented in India.

Many other generic manufacturers have followed suit in otherdeveloping countries, such as Thailand, where the medicines
were not patented.
Extensive competition from numerous generic manufacturers
has made this combination the most affordable ARV
treatment to date.
Paediatrics This is one of the most-commonly used first-line
regimens for children today.
The Paediatric Working Group at WHO has now released clear
guidance on the ideal strength of each of the individual ARVs
in these fixed-dose combinations, and today there are two
formulations listed on the WHO List of Prequalified Medicinal
Products.169

58 • Médecins Sans Frontières • January 2010 • Untangling the Web of ARV Price Reductions • Please check utw.msfaccess.org

LAMIVUDINE/STAVUDINE + EFAVIRENZ (3TC/d4T + EFV)
General information• Therapeutic class: two NRTIs + one NNRTI in
a co-blister.

FIXED-DOSE COMBINATIONS & CO-PACKS

Price information: Prices in US$ quoted by companies for eligible developing countries
Daily dose
Eligibility restrictions
1 kit(3 tablets)

Cipla

Ranbaxy

Strides

None

None

None

274 (0.751)

345 (0.945)

176 (0.483)• Indicated for first-line for adults,
adolescents and children (WHO 2006
guidelines).159,160

3TC/d4T + EFV
150/30 + 600mg
tablets (Co-pack)• WHO updated the 2006 guidelines torecommend a reduction in dose of d4T from40 to 30mg for all weight categories ofpatients.161

Products included in the WHO List of Prequalified Medicinal Products (as of December 2009) arein BOLD in the table.

• Not included in the WHO Model List of
Essential Medicines (EML) as a co-pack, but
the individual drugs are included in the
EML.162

Spotlight on access issues:• The WHO Expert Committee on the
Selection and Use of Essential Medicines
recommends and endorses the use of fixeddose combinations and the development ofappropriate new fixed-dose combinations.163

In December 2009, WHO released new recommendations for antiretroviral therapy
for HIV in adults and adolescents. These new recommendations advise countries tophase out stavudine-based regimens because of their long term irreversible side
effects and to move towards zidovudine (AZT) or tenofovir (TDF)-based first-line
regimens. We can therefore expect to see a decrease in the use of this formulationin the future.375• Individual patents on lamivudine (3TC),
stavudine (d4T) or efavirenz (EFV) also affectthis combination. In addition, other patents
may have been applied for more specificallyrelated to the use of the medicines incombination, or to the FDC.

Generic companies in certain developing countries were able to develop this coblister because patents on the individual components contained in the
combination did not exist. This product is not available in developed countries orin China because of various patents on lamivudine (3TC), stavudine (d4T) and/or
efavirenz (EFV).

For information on the individual ARVs
contained in this fixed-dose combination,please refer to the individual drug profiles.

Médecins Sans Frontières • January 2010 • Untangling the Web of ARV Price Reductions • Please check utw.msfaccess.org • 59

TENOFOVIR DISOPROXIL FUMARATE/EMTRICITABINE (TDF/FTC)
General information

Price information: Prices in US$ quoted by companies for eligible developing countries• Therapeutic class: one NtRTI + one NRTI in
a double fixed-dose combination.
• Indicated for first-line and second-line for
adults and adolescents (WHO 2006
guidelines).266,267

FIXED-DOSE COMBINATIONS & CO-PACKS

GileadDaily dosesee annexes 2 and 9

Eligibility restrictions
TDF/FTC
300/200mg tablet

Aurobindo (CF) Cipla (CF)1319 (0.875)

Matrix (CF)Category 2

Category 1

548 (1.500)

None

None

None

164 (0.450)

152 (0.417)

158 (0.433)• Originator company and product brand
name: Gilead, Truvada.

(CF) The Clinton Foundation has negotiated with this manufacturer for reduced prices on some formulations forcountries in their consortium. See Annex 13 for details.

• First approval by U.S. Food and Drug
Administration (FDA): August 2004.268

Products included in the WHO List of Prequalified Medicinal Products (as of December 2009) are in BOLD in thetable.

• Included in the 16th edition of the WHO
Model List of Essential Medicines (EML).269• World sales of originator product: 2008:
US$ 2.11 billion; 2007: US$ 1.59 billion;
2006: US$ 1.19 billion; 2005: US$ 568
million; 2004: US$ 68 million.271• Most patents related to tenofovir (TDF) or
to emtricitabine (FTC) also affect thiscombination. In addition, Gilead applied forpatents specifically related to thiscombination in 2004, which are due to expire
in 2024.272

TDF/FTC 300/200mg

Evolution of the lowest price quoted for
eligible developing countries since 2005:

generic pricelowest originator price

US$ ppy• The WHO Expert Committee on the
Selection and Use of Essential Medicines
recommends and endorses the use of fixeddose combinations and the development ofappropriate new fixed-dose combinations.270

400
350
300
250
200
150
100
50
0

319

362
274

158

Feb
2005

June
2005

June
2006

June
2007

June
2008

Dec
2009

Month/YearFor information on the individual ARVs
contained in this fixed-dose combination,please refer to the individual drug profiles.

60 • Médecins Sans Frontières • January 2010 • Untangling the Web of ARV Price Reductions • Please check utw.msfaccess.org

As of December 2009, there were twogeneric sources of TDF/FTC 300/200mg listedon the WHO List of Prequalified Medicinal
Products and the lowest-priced product on
the List is shown here.
Since 2007, there has been a 45% decreasein the generic price.

TENOFOVIR DISOPROXIL FUMARATE/EMTRICITABINE (TDF/FTC)
Spotlight on access issues:This combination is likely to be widely used in developing countries as a backbone
in first- and second-line regimens. In December 2009, WHO released newrecommendations for antiretroviral therapy for HIV in adults and adolescents. These
new recommendations advise countries to phase out stavudine-based regimens
because of their long term irreversible side effects and to move towards zidovudine(AZT) or tenofovir (TDF)-based first-line regimens.375
For many years, the stavudine (d4T)-containing regimen has played a crucial role in
ART scale-up in resource-limited settings, due to its availability in a fixed-dose
combination and most importantly its low cost. d4T remains a widely-used ARV in
first-line regimens.
It is however time for countries to invest in a more robust, TDF-containing first-line
regimen, such as TDF/3TC/EFV or TDF/FTC/EFV, which is one pill once a day. While
the price today is still higher than a d4T-containing regimen, there is a need togenerate greater demand which will, in turn, increase the competition needed tofurther decrease prices.
For second-line treatment, TDF in combination with lamivudine (3TC) or emtricitabine(FTC) are the recommended NRTI backbones to be added to a boosted proteaseinhibitor, if stavudine or zidovudine have been used in the first-line regimen.
For HIV patients requiring treatment for hepatitis B, the first- and second-line
treatment should contain TDF and 3TC or FTC.
Today, there are two generic sources listed on the WHO List of Prequalified
Medicinal Products.
Patents This combination is being developed by Indian generic companies because
neither of the individual components is patented in India today. However, Gilead has
applied for patents related to TDF. If these patents are granted in India, genericcompetition for this product may be affected.

FIXED-DOSE COMBINATIONS & CO-PACKS

In a major victory for access to medicines, the Indian patent office rejected several
patent applications relating to TDF in September 2009. The patents were rejected on
the grounds that they lack an inventive step - they do not meet the requirement ofenhanced efficacy stipulated under Section 3(d) of India's patent law. Further,
combinations of known molecules are not patentable under Indian patent law.273,274,275
Nevertheless, divisional applications (a type of patent application which contains
matter from a previously filed application) have been filed by Gilead for this andother patent applications. This means that although the patent was not granted, thepatent applications are still pending before the patent office.
The same is true in Brazil, where the government declared its public interest in TDF
in April 2008, considering it to be an essential drug. The National Institute on
Industrial Property (INPI) published the patent rejection for TDF on 30 June 2009.
However, Gilead has also requested a divisional patent for the previously rejected
patent.
Following oppositions to the grant of its patents in India, Gilead signed licensing
agreements with ten generic manufacturers in India, allowing them to manufactureand export generic versions of Gilead's products to a limited pre-defined list of
countries, against the payment of a 5% royalty.276
Manufacturers that have signed these agreements are unable to supply countries
such as Brazil and China, leaving these countries unable to benefit from competitive
prices and improve access. After negotiation with Gilead, Brazil is today paying
US$ 927 per patient per year, over ten times the best available generic price.
Such licensing agreements can contribute to increased competition and improved
access to affordable medicines, but should also be offered to manufacturers outside
India, and should not include geographic market limitations.
Paediatrics TDF is not currently approved for children younger than 18 years.

Médecins Sans Frontières • January 2010 • Untangling the Web of ARV Price Reductions • Please check utw.msfaccess.org • 61

TENOFOVIR DISOPROXIL FUMARATE/EMTRICITABINE/EFAVIRENZ (TDF/FTC/EFV) FIXED-DOSE COMBINATIONS & CO-PACKS
General information

Price information: Prices in US$ quoted by companies for eligible developing countries• Therapeutic class: one NtRTI + one NRTI +one NNRTI in a triple fixed-dose combination.

Gilead/BMS/Merck• Indicated for first-line for adults (WHO 2006
guidelines).279,280

Daily dose

Category 1

Matrix
(CF)

Cipla

None

None

Category 2

see annexes 2 and 10• Originator company and product brand
name: Gilead/Bristol-Myers Squibb/Merck,
Atripla.

Eligibility restrictions• First approval by U.S. Food and Drug
Administration (FDA): July 2006.281(CF) The Clinton Foundation has negotiated with this manufacturer for reduced prices on some formulations forcountries in their consortium. See Annex 13 for details.

• Included in the 16th edition of the WHO
Model List of Essential Medicines (EML).282

Products included in the WHO List of Prequalified Medicinal Products (as of December 2009) are in BOLD in the table.

• The WHO Expert Committee on the Selection
and Use of Essential Medicines recommends
and endorses the use of fixed-dose
combinations and the development ofappropriate new fixed-dose combinations.283

TDF/FTC/EFV 300/200/600mg tablet

TDF/FTC/EFV 300/200/600mg• World sales of the originator: 2008: US$
1.572 billion; 2007: US$ 903 million; 2006,
US$ 164 million (the product entered themarket in the third quarter of the year).284• Gilead pays royalties to BMS (andconsequently Merck) for the EFV portion,
originally owned by Dupont Merck, which was
subsequently acquired by BMS.

613 (1.680)

generic price1033 (2.830) 268 (0.733)

268 (0.733)

Evolution of the lowest price quoted for eligible developing countries
since 2007:

lowest originator price

700

613

613

600
500
US$ ppy• Most patents related to tenofovir (TDF),
emtricitabine (FTC), TDF/FTC or to efavirenz(EFV) also affect this combination. In addition,
Gilead and BMS jointly applied for patents
specifically related to this combination in
2006,285,286 which would last until 2026.

1

487

400

As of December 2009, there was no generic source of TDF/FTC/EFV
300/200/600mg listed on the WHO List of Prequalified Medicinal
Products. The lowest available generic price is shown here.
Since 2007, the generic price has decreased by 45%, while originator
price has remained the same.

300
268

200
100
0
June 2007

June 2008

Dec 2009

Month/Year• This is the first one-pill-a-day fixed-dose
combination, which makes it well-adapted toresource-poor settings.
For information on the individual ARVs
contained in this fixed-dose combination
please refer to the individual drug profiles.

62 • Médecins Sans Frontières • January 2010 • Untangling the Web of ARV Price Reductions • Please check utw.msfaccess.org

TENOFOVIR DISOPROXIL FUMARATE/EMTRICITABINE/EFAVIRENZ (TDF/FTC/EFV) FIXED-DOSE COMBINATIONS & CO-PACKS
Spotlight on access issues:This is the first one-pill-a-day fixed-dose combination, which makes it well-adapted
to resource-poor settings.
For many years, the stavudine (d4T)-containing regimen has played a crucial role in
ART scale-up in resource-limited settings, due to its availability in a fixed-dose
combination and most importantly its low cost. d4T remains a widely-used ARV in
first-line regimens.

the grounds that they lack an inventive step – they do not meet the requirement ofenhanced efficacy stipulated under Section 3(d) of India's patent law. Further,
combinations of known molecules are not patentable under Indian patent law.287,288,289
Nevertheless, divisional applications (a type of patent application which contains
matter from a previously filed application) have been filed by Gilead for this andother patent applications. This means that although the patent was not granted, thepatent applications are still pending before the patent office.

In December 2009, WHO released new recommendations for antiretroviral therapy for
HIV in adults and adolescents. These new recommendations advise countries tophase out stavudine-based regimens because of their long term irreversible side
effects and to move towards zidovudine or tenofovir-based first-line regimens.
Efavirenz (EFV) is the preferred NNRTI for use in patients starting ART while on TB
treatment.375

The same is true in Brazil, where the government declared its public interest in TDF
in April 2008, considering it to be an essential drug. The National Institute on
Industrial Property (INPI) published the patent rejection for TDF on 30 June 2009.
However, Gilead has also requested a divisional patent for the previously rejected
patent.

It is time for countries to invest in a more robust, first-line regimen containing TDF,
such as TDF/FTC/EFV (or TDF/3TC/EFV). While the price today is still higher than ad4T-containing regimen, there is a need to generate greater demand which will, in
turn, increase the competition needed to further decrease prices.

Following oppositions to the grant of its patents in India, Gilead signed licensing
agreements with ten generic manufacturers in India, allowing them to manufactureand export generic versions of Gilead's products to a limited pre-defined list of
countries, against the payment of a 5% royalty.290

Today, there is one generic source which is tentatively approved by the U.S. FDA, but
it is not prequalified by WHO.

Manufacturers that have signed these agreements are unable to supply countries
such as Brazil and China, leaving these countries unable to benefit from competitive
prices and improve access. After negotiation with Gilead, Brazil is today paying
US$ 927 per patient per year, over ten times the best available generic price.

Patents This combination is being developed by Indian generic companies because
none of the individual components is patented in India today. However, Gilead has
applied for patents related to TDF. If these patents are granted in India, genericcompetition for this product may be affected.
In a major victory for access to medicines, the Indian patent office rejected several
patent applications relating to TDF in September 2009. The patents were rejected on

Such licensing agreements can contribute to increased competition and improved
access to affordable medicines, but should also be offered to manufacturers outside
India, and should not include geographic market limitations.
Paediatrics TDF is not currently approved for children younger than 18 years.

Médecins Sans Frontières • January 2010 • Untangling the Web of ARV Price Reductions • Please check utw.msfaccess.org • 63

TENOFOVIR DISOPROXIL FUMARATE/LAMIVUDINE (TDF/3TC)
General information

FIXED-DOSE COMBINATIONS & CO-PACKS

Price information: Prices in US$ quoted by companies for eligible developing countries• Therapeutic class: NtRTI + NRTI in a double
fixed-dose combination.

Daily dose

Cipla
None

Matrix (CF)None

1

134 (0.367)

134 (0.367)

Eligibility restrictions• Indicated for first-line and second-line for
adults and adolescents (2006 WHO
guidelines).292,293

TDF/3TC
300/300mg tablet• Not included in the WHO Model List of
Essential Medicines (EML) as a fixed-dose
combination, but the individual drugs areincluded in the EML.294(CF) The Clinton Foundation has negotiated with this manufacturer for reduced prices
on some formulations for countries in their consortium. See Annex 13 for details.

• Most patents related to tenofovir (TDF) or
to lamivudine (3TC) also affect thiscombination. In addition, other patents may
have been applied for, more specificallyrelated to the use of these medicines incombination, or to this specific FDC. Cipla
applied for patents more specifically related
to this combination.296
For information on the individual ARVs
contained in this fixed-dose combination
please refer to the individual drug profiles.

Products included in the WHO List of Prequalified Medicinal Products (as of December2009) are in BOLD in the table.

TDF/3TC 300/300mg

Evolution of the lowest quoted price for
eligible developing countries since 2006:

generic pricelowest originator price1200

As of December 2009, there were twogeneric sources of TDF/3TC 300/300mg
listed on the WHO List of Prequalified
Medicinal Products and the lowest-priced
product on the List is shown here.

1034
1000
800
US$ ppy• The WHO Expert Committee on the
Selection and Use of Essential Medicines
recommends and endorses the use of fixeddose combinations and the development ofappropriate new fixed-dose combinations.295

600
400

276

271

200

134

0
June 2006

June 2007

June 2008

Month/YearDec 2009

As there is no originator fixed-dose
combination, the price shown for theoriginator is for the combination of thetwo individual originator products.
Since 2006, the generic price has
dropped by 87%.

64 • Médecins Sans Frontières • January 2010 • Untangling the Web of ARV Price Reductions • Please check utw.msfaccess.org

TENOFOVIR DISOPROXIL FUMARATE/LAMIVUDINE (TDF/3TC)
Spotlight on access issues:

FIXED-DOSE COMBINATIONS & CO-PACKS

For many years, the stavudine (d4T)-containing regimen has played a crucial role in
ART scale-up in resource-limited settings, due to its availability in a fixed-dose
combination and, most importantly, its low cost. d4T remains a widely-used ARV in
first-line regimens.

In a major victory for access to medicines, the Indian patent office rejected several
patent applications relating to TDF in September 2009. The patents were rejectedon the grounds that they lack an inventive step – they do not meet the requirementof enhanced efficacy stipulated under Section 3(d) of India's patent law. Further,
combinations of known molecules are not patentable under Indian patent law.297,298,299

In December 2009, WHO released new recommendations for antiretroviral therapy
for HIV in adults and adolescents. These new recommendations advise countries tophase out stavudine-based regimens because of their long-term irreversible side
effects and to move towards zidovudine or tenofovir-based first-line regimens.375

Nevertheless, divisional applications (a type of patent application which contains
matter from a previously filed application) have been filed by Gilead for this andother patent applications. This means that although the patent was not granted, thepatent applications are still pending before the patent office.

It is time for countries to invest in a more robust, TDF-containing first-line regimen,
such as TDF/3TC/EFV or TDF/FTC/EFV, which is one pill, once a day. While the pricetoday is still higher than a d4T-containing regimen, there is a need to generate
greater demand which will, in turn, increase the competition needed to further
decrease prices.

The same is true in Brazil, where the government declared its public interest in TDF
in April 2008, considering it to be an essential drug. The National Institute on
Industrial Property (INPI) published the patent rejection for TDF on 30 June 2009.
However, Gilead has also requested a divisional patent for the previously rejected
patent.

For second-line treatment, TDF in combination with lamivudine (3TC) or
emtricitabine (FTC) are the recommended NRTI backbones to be added to a boosted
protease inhibitor, if stavudine or zidovudine have been used in the first-line
regimen.

Following oppositions to the grant of its patents in India, Gilead signed licensing
agreements with ten generic manufacturers in India, allowing them to manufactureand export generic versions of Gilead's products to a limited pre-defined list of
countries, against the payment of a 5% royalty.300

For HIV patients requiring treatment for hepatitis B, the first- and second-line
treatment should contain TDF and 3TC or FTC.

Manufacturers that have signed these agreements are unable to supply countries
such as Brazil and China, leaving these countries unable to benefit from competitive
prices and improve access. After negotiation with Gilead, Brazil is today paying
US$ 927 per patient per year, over ten times the best available generic price.

Today there are two generic sources of TDF/3TC listed on the WHO List ofPrequalified Medicinal Products.
Patents This combination is being developed by Indian generic companies because
none of the individual components is patented in India today. However, Gilead has
applied for patents related to TDF. If these patents are granted in India, genericcompetition for this product may be affected.

Such licensing agreements can contribute to increased competition and improved
access to affordable medicines, but should also be offered to manufacturers outside
India, and should not include geographic market limitations.
Paediatrics TDF is not currently approved for children younger than 18 years.

Médecins Sans Frontières • January 2010 • Untangling the Web of ARV Price Reductions • Please check utw.msfaccess.org • 65

TENOFOVIR DISOPROXIL FUMARATE/LAMIVUDINE/EFAVIRENZ (TDF/3TC/EFV)
General information

Price information: Prices in US$ quoted by companies for eligible
developing countries• Therapeutic class: one NtRTI + one NRTI +one NNRTI in a triple fixed-dose
combination.

Eligibility restrictions• Indicated for first-line for adults (WHO2006 guidelines).303,304

TDF/3TC/EFV
300/150/600mg tablet (FDC)1

TDF/3TC 300/150 mg + EFV
600mg (Co-Pack)

1 kit(2 tabs)• Not included in the WHO Model List of
Essential Medicines (EML) as a fixed-dose
combination, but the individual drugs areincluded in the EML.305

Daily dose

Cipla

Matrix (CF)

None

None
243 (0.667)

350 (0.959)(CF) The Clinton Foundation has negotiated with this manufacturer for reduced prices
on some formulations for countries in their consortium. See Annex 13 for details.

• The WHO Expert Committee on the
Selection and Use of Essential Medicines
recommends and endorses the use of fixeddose combinations and the development ofappropriate new fixed-dose combinations.306
TDF/3TC/EFV 300/300mg

For information on the individual ARVs
contained in this fixed-dose combinationand co-pack please refer to the individual
drug profiles.

generic price

Evolution of the lowest quoted price for eligible
developing countries since 2007:

lowest originator price

600
500
400
US$ ppy• Most patents related to tenofovir (TDF),
lamivudine (3TC) or to efavirenz (EFV) also
affect this combination. In addition, otherpatents may have been applied for more
specifically related to the use of these
medicines in combination, or to this specific
FDC.

FIXED-DOSE COMBINATIONS & CO-PACKS

513

508

426

300
Month/Year

200

243

100
0
June 2007

June 2008

December 2009

As of December 2009, there was no genericsource of TDF/3TC/EFV 300/300/600mg listed on
the WHO List of Prequalified Medicinal Products.
The lowest available generic price is therefore
shown in the graph.
As there is no originator fixed-dose combination,
the price shown for the originator is for the
combination of the three individual originatorproducts.
Since 2007, the generic price has dropped by
43%.

66 • Médecins Sans Frontières • January 2010 • Untangling the Web of ARV Price Reductions • Please check utw.msfaccess.org

TENOFOVIR DISOPROXIL FUMARATE/LAMIVUDINE/EFAVIRENZ (TDF/3TC/EFV)
Spotlight on access issues:
For many years, the stavudine (d4T)-containing regimen has played acrucial role in ART scale-up in resource-limited settings, due to its
availability in a fixed-dose combination and, most importantly, its low
cost. d4T remains a widely-used ARV in first-line regimens.
In December 2009, WHO released new recommendations for
antiretroviral therapy for HIV in adults and adolescents. These newrecommendations advise countries to phase out stavudine-based
regimens because of their long-term irreversible side effects and to movetowards zidovudine or tenofovir-based first-line regimens. Efavirenz (EFV)
is the preferred NNRTI for use in patients starting ART while on TB
treatment.375
It is time for countries to invest in a more robust, TDF-containing firstline regimen, such as TDF/3TC/EFV or TDF/FTC/EFV, which is one pill oncea day. While the price today is still higher than a d4T-containing
regimen, there is a need to generate greater demand which will, in turn,increase the competition needed to further decrease prices.
Today there is one generic source of TDF/3TC/EFV tentatively approvedby the U.S. FDA but it is not yet listed on the WHO Prequalification Listof Medicinal Products.
Patents This combination is being developed by Indian genericcompanies because none of the individual components is patented inIndia today. However, Gilead has applied for patents related to TDF. Ifthese patents are granted in India, generic competition for this productmay be affected.
In a major victory for access to medicines, the Indian patent office
rejected several patent applications relating to TDF in September 2009.
The patents were rejected on the grounds that they lack an inventive
step – they do not meet the requirement of enhanced efficacy stipulated

FIXED-DOSE COMBINATIONS & CO-PACKS

under Section 3(d) of India's patent law. Further, combinations of known
molecules are not patentable under Indian patent law.307,308,309
Nevertheless, divisional applications (a type of patent application whichcontains matter from a previously filed application) have been filed by
Gilead for this and other patent applications. This means that although
the patent was not granted, the patent applications are still pending
before the patent office.
The same is true in Brazil, where the government declared its public
interest in TDF in April 2008, considering it to be an essential drug. The
National Institute on Industrial Property (INPI) published the patent
rejection for TDF on 30 June 2009. However, Gilead has also requested adivisional patent for the previously rejected patent.
Following oppositions to the grant of its patents in India, Gilead signed
licensing agreements with ten generic manufacturers in India, allowing
them to manufacture and export generic versions of Gilead's products toa limited pre-defined list of countries, against the payment of a 5%
royalty.310
Manufacturers that have signed these agreements are unable to supply
countries such as Brazil and China, leaving these countries unable tobenefit from competitive prices and improve access. After negotiation
with Gilead, Brazil is today paying US$ 927 per patient per year, overten times the best available generic price.
Such licensing agreements can contribute to increased competition andimproved access to affordable medicines, but should also be offered to
manufacturers outside India, and should not include geographic market
limitations.
Paediatrics TDF is not currently approved for children younger than 18
years.

Médecins Sans Frontières • January 2010 • Untangling the Web of ARV Price Reductions • Please check utw.msfaccess.org • 67

ZIDOVUDINE/LAMIVUDINE (AZT/3TC)
General information

FIXED-DOSE COMBINATIONS & CO-PACKS

Price information: Prices in US$ quoted by companies for eligible developing countries• Therapeutic class: two NRTIs in double
fixed-dose combination.
• Indicated for first- and second-line for
adults and adolescents, and only for first-line
for children (WHO 2006 guidelines).329,330• Originator company and product brand
name: GlaxoSmithKline (GSK), Combivir. In
April 2009, Pfizer and GSK jointly announced
the creation of ViiV, a new joint venture
focusing solely on the R&D andcommercialisation of HIV medicines.

EmcureMatrix (CF)Ranbaxy

Strides (CF)

None

None

None

None

None

117 (0.160)

91 (0.125)

122 (0.167) 124 (0.170) 146 (0.200)

GSK

Aurobindo (CF) Cipla (CF)Eligibility restrictions

see annex 2

None

AZT/3TC 300/150mg tablet 2

197 (0.270)

122 (0.167)

Daily
dose

AZT/3TC 60/30mg tablet

4

146 (0.100)

121 (0.083)(CF) The Clinton Foundation has negotiated with this manufacturer for reduced prices on some formulations for countries in theirconsortium. See Annex 13 for details.
Products included in the WHO List of Prequalified Medicinal Products (as of December 2009) are in BOLD in the table.

• First approval by U.S. Food and Drug
Administration (FDA): September 1997.331• Included in the 16th edition of the WHO
Model List of Essential Medicines (EML).332• World sales of the originator: 2008:
US$ 713 million; 2007: US$ 888 million;
2006: US$ 1,042 million; 2005: US$ 1,150
million; 2004: US$ 1,125 million.334,335,336,337,338• Most patents related to zidovudine (AZT) or
to lamivudine (3TC) also affect thiscombination. In addition, GSK applied forpatents specifically related to the use of AZTand 3TC in combination,339 and for the tablet
formulation of the FDC,340 which are due toexpire in 2012 and 2017, respectively.

AZT/3TC 300/150mg tablet

Evolution of the lowest price quoted for eligible developing countries
since 2002:

generic pricelowest originator price700

As of December 2009, there were nine generic sources of AZT/3TC
300/150mg listed on the WHO List of Prequalified Medicinal Products
and the lowest-priced product on the List is shown here.

730

600
500
US$ ppy• The WHO Expert Committee on the
Selection and Use of Essential Medicines
recommends and endorses the use of fixeddose combinations and the development ofappropriate new fixed-dose combinations.333

Competition among WHO prequalified sources continues, and has led toa steady decrease in prices of the originator product by 73% and thegeneric by 66% since 2001.

400
300

270

197

200
100

91

0

June Dec May Dec Apr Feb June June June June Dec
2002 2002 2003 2003 2004 2005 2005 2006 2007 2008 2009

Month/YearFor information on the individual ARVs
contained in this fixed-dose combination
please refer to the individual drug profiles.

68 • Médecins Sans Frontières • January 2010 • Untangling the Web of ARV Price Reductions • Please check utw.msfaccess.org

ZIDOVUDINE/LAMIVUDINE (AZT/3TC)
Spotlight on access issues:
There will be a continued need for this important FDC.
For many years, the stavudine (d4T)-containing regimen has
played a crucial role in ART scale-up in resource-limited
settings, due to its availability in a fixed-dose combination
and, most importantly, its low cost. d4T remains a widelyused ARV in first-line regimens.
In December 2009, WHO released new recommendations for
antiretroviral therapy for HIV in adults and adolescents. These
new recommendations advise countries to phase out
stavudine-based regimens because of their long-term
irreversible side effects and to move towards zidovudine or
tenofovir-based first-line regimens.375
For second-line treatment, AZT in combination with 3TC is therecommended NRTI backbone to be added to a boosted
protease inhibitor (PI) if tenofovir has been used in the firstline regimen.
Patents Generic versions of this combination were developedin countries where neither of the molecules, nor their
combination, were patented. However, the generic versions of
the medicine produced in India came under threat when India
began granting patents on pharmaceuticals in 2005, as GSK
had applied for a patent on the combination.

FIXED-DOSE COMBINATIONS & CO-PACKS
Civil society organisations in India opposed the patentapplication in March 2006,341 which resulted in GSK
communicating in August 2006 that patents specificallyrelated to the fixed-dose combination were being withdrawn
in all countries.342
Yet in some countries, generic versions of the FDC are notavailable because of GSK patent rights. In China, for example,
GSK's exclusive rights on lamivudine (3TC) alone have led to
the fact that only the originator product is available at
US$ 1,839 per patient per year.
Paediatrics The most commonly used first-line regimens forchildren today are either AZT+3TC+NVP or d4T+3TC+NVP. With
both of these regimens, there is a need to start the NVP at alower dose for the first two weeks to minimise the side
effects.
For simplification, there is an urgent need for a qualityassured double FDC to allow children to be safely andaccurately dosed while starting treatment. The alternative is
to use two different syrups, which can be difficult toadminister. Today, there are two paediatric AZT/3TC FDC
tablets listed on the WHO List of Prequalified Medicinal
Products. The Paediatric Antiretroviral Working Group at WHO
has classed the development of a paediatric AZT/3TC FDC asan “urgent” priority.343

Médecins Sans Frontières • January 2010 • Untangling the Web of ARV Price Reductions • Please check utw.msfaccess.org • 69

ZIDOVUDINE/LAMIVUDINE/ABACAVIR (AZT/3TC/ABC)
General information

FIXED-DOSE COMBINATIONS & CO-PACKS

Price information: Prices in US$ quoted by companies for eligible developing countries
Daily dose

• Therapeutic class: three NRTIs in triple
fixed-dose combination.
Eligibility restrictions• Indicated for first-line for adults,
adolescents and children (WHO 2006
guidelines).350,351• The WHO Expert Committee on the
Selection and Use of Essential Medicines
recommends and endorses the use of fixeddose combinations and the development ofappropriate new fixed-dose combinations.352• Originator company and product brand
name: GlaxoSmithKline (GSK), Trizivir. In April
2009, Pfizer and GSK jointly announced thecreation of ViiV, a new joint venture focusing
solely on the R&D and commercialisationof HIV medicines.

AZT/3TC/ABC 300/150/300mg tablet (FDC)

2

Cipla

MatrixRanbaxy

see annex 2

None

None

None

None

414 (0.567)

365 (0.500)

639 (0.875)

653 (0.895)

AZT/3TC/ABC 60/30/60mg tablet (FDC)

402 (1.100)

4244 (0.167)

Products included in the WHO List of Prequalified Medicinal Products (as of December 2009) are in BOLD in the table.

AZT/3TC/ABC 300/150/300mg tablet

Evolution of the lowest price quoted for eligible
developing countries since 2001:

generic pricelowest originator price3000

As of December 2009, there was one genericsource of AZT/3TC/ABC 300/150/300mg listed on
the WHO List of Prequalified Medicinal Products
and the lowest-priced product on the List is
shown here.

2500 2409
US$ ppy2000• Most patents on zidovudine (AZT),
lamivudine (3TC), AZT/3TCa or abacavir (ABC)also affect this combination. In addition, GSK
applied for patents more specifically related
to the combination.359

Aurobindo

AZT/3TC + ABC 300/150 + 300mg tablets (co-pack) 1 kit (4 tabs)• First approval by U.S. Food and Drug
Administration (FDA): November 2000.353• World sales of originator product: 2008:
US$ 350 million; 2007: US$ 455 million;
2006: US$ 529 million; 2005: US$ 598
million; 2004: US$ 635 million.354,355,356,357,358

GSK

1500

1648

1000

653

50

639

0

There has been a decrease of 61% in thegeneric price and 73 % in the originator pricesince 2001.

Oct Jun Dec May Dec Apr Feb June June June June Dec
2001 2002 2002 2003 2003 2004 2005 2005 2006 2007 2008 2009

Month/YearFor information on the individual ARVs
contained in this fixed-dose combination,please refer to the individual drug profiles.

70 • Médecins Sans Frontières • January 2010 • Untangling the Web of ARV Price Reductions • Please check utw.msfaccess.org

Spotlight on access issues:This FDC is the only triple NRTI formulation
available. It is one of the most-commonlyprescribed regimens in the developed world,
but the market is very small in developing
countries. This combination at best costs morethan three times what the most commonly used
fixed-dose combination (3TC/d4T/NVP) costs
today. This is predominately because of thehigh cost of abacavir (ABC).
Patents GlaxoSmithKline (GSK) could not apply
for basic patents related to abacavir (ABC),
zidovudine (AZT) or lamivudine (3TC) in somedeveloping countries such as India, which did
not grant patents on pharmaceuticals at thetime. This allowed Indian generic companies todevelop generic versions of each medicine, andof the combination. However, GSK widely
applied for patents in other developing
countries, where possible. In India, GSK had
applied for patents more specifically related to
the fixed-dose combination. The company
withdrew the patent application after a pre-grant
opposition was filed in 2006.360
Paediatrics The paediatric formulation of
AZT/3TC/ABC is a generic version and is now
listed on the WHO Prequalification List of
Medicinal Products. However, this product is notcommercially available yet because there is notenough market demand to make the productcommercially viable.

Médecins Sans Frontières • January 2010 • Untangling the Web of ARV Price Reductions • Please check utw.msfaccess.org • 71

ZIDOVUDINE/LAMIVUDINE/NEVIRAPINE (AZT/3TC/NVP)
General information• Therapeutic class: two NRTI + one NNRTI in
triple fixed-dose combination.
• Indicated for first-line for adults,
adolescents and children (WHO 2006
guidelines).361,362• Included in the 16th edition of the WHO
Model List of Essential Medicines (EML).363

FIXED-DOSE COMBINATIONS & CO-PACKS

Price information: Prices in US$ quoted by companies for eligible developing countries
Daily dose

Aurobindo (CF) Cipla (CF)None

Eligibility restrictions
AZT/3TC/NVP 300/150/200mg tablet

2

AZT/3TC/NVP 60/30/50mg tablet

4

158 (0.217)

None

Matrix (CF) Ranbaxy
None

None

151 (0.207) 158 (0.217) 183 (0.250)
158 (0.108)(CF) The Clinton Foundation has negotiated with this manufacturer for reduced prices on some formulations for countries intheir consortium. See Annex 13 for details.
Products included in the WHO List of Prequalified Medicinal Products (as of December 2009) are in BOLD in the table.

• The WHO Expert Committee on the
Selection and Use of Essential Medicines
recommends and endorses the use of fixeddose combinations and the development ofappropriate new fixed-dose combinations.364

For information on the individual ARVs
contained in this fixed-dose combination,please refer to the individual drug profiles.

AZT/3TC/NVP 300/300/200mg tablet

Evolution of the lowest price quoted for eligible
developing countries since 2001:

generic pricelowest originator price

US$ ppy• Most patents related to zidovudine (AZT),
lamivudine (3TC), AZT/3TC or to nevirapine(NVP) also affect this combination. In
addition, other patents may have been
applied for more specifically related to theuse of these medicines in combination, or forthis specific FDC.

1600
1400
1200
1000
800
600
400
200
0

As of December 2009, there were six generic sources of
AZT/3TC/NVP 300/300/200mg listed on the WHO List ofPrequalified Medicinal Products and the lowest-priced
product on the List is shown here.

1356

444

419

151
Oct June Dec May Dec Apr Feb June June June June Dec
2001 2002 2002 2003 2003 2004 2005 2005 2006 2007 2008 2009

As there is no originator fixed-dose combination, the priceshown for the originator is for the combination of thethree individual originator products.
Generic prices have steadily decreased by 64% since
2001.

Month/Year72 • Médecins Sans Frontières • January 2010 • Untangling the Web of ARV Price Reductions • Please check utw.msfaccess.org

ZIDOVUDINE/LAMIVUDINE/NEVIRAPINE (AZT/3TC/NVP)

FIXED-DOSE COMBINATIONS & CO-PACKS

Spotlight on access issues:
For many years, the stavudine (d4T)-containing regimen has
played a crucial role in ART scale-up in resource-limited
settings, due to its availability in a fixed-dose combination
and, most importantly, its low cost. d4T remains a widelyused ARV in first-line regimens.
In December 2009, WHO released new recommendations for
antiretroviral therapy for HIV in adults and adolescents.
These new recommendations advise countries to phase out
stavudine-based regimens because of their long term
irreversible side effects and to move towards zidovudine or
tenofovir-based first-line regimens.375
Patents In addition to the generic manufacturers referenced
above, Apotex also manufactures an AZT/3TC/NVP fixed-dose
combination374 for export to developing countries under the
30 August 2003 World Trade Organization decision on
compulsory licensing (CL) for export.365

In early 2004, MSF made the original request for thedevelopment of this FDC to Apotex, as no generic versions of
the FDC were available at the time.366
MSF, however, ultimately ended up procuring the FDC frommanufacturers in India, which reached the market earlier
because the Indian manufacturers were not hampered by theprocedural requirements of the new WTO rules on CL for
export.
Paediatrics The most-commonly used first-line regimens forchildren today are either AZT+3TC+NVP or d4T+3TC+NVP.
Today, there is one paediatric AZT/3TC/NVP FDC tablet listedon the WHO List of Prequalified Medicinal Products.
For simplification, there is an urgent need for more sourcesof quality-assured triple FDCs, to allow children to be safely
and accurately dosed.

Médecins Sans Frontières • January 2010 • Untangling the Web of ARV Price Reductions • Please check utw.msfaccess.org • 73

ZIDOVUDINE/LAMIVUDINE + EFAVIRENZ (AZT/3TC + EFV)
General information• Therapeutic class: two NRTI + one NNRTI in
a co-blister.
• Indicated for first-line for adults,
adolescents and children (WHO 2006
guidelines).346,347

FIXED-DOSE COMBINATIONS & CO-PACKS

Price information: Prices in US$ quoted by companies for eligible developing countries
Daily dose
Eligibility restrictions
AZT/3TC + EFV
300/150 + 600mg tablets (co-pack)

1 kit(3 tabs)

Aurobindo

Cipla

Ranbaxy

Strides

None

None

None

None

286 (0.783)

320 (0.877)

434 (1.190)

249 (0.682)

Products included in the WHO List of Prequalified Medicinal Products (as of December 2009) are in BOLD in the table.
• The WHO Expert Committee on the
Selection and Use of Essential Medicines
recommends and endorses the use of fixeddose combinations and the development ofappropriate new fixed-dose combinations.348• Most patents related to zidovudine (AZT),
lamivudine (3TC), AZT/3TC or to efavirenz(EFV) also affect this combination. In addition,
Cipla applied for patents specifically related
to the use of AZT, 3TC and EFV in
combination.349
For information on the individual ARVs
contained in this fixed-dose combination,please refer to the individual drug profiles.

Spotlight on access issues:
For many years, the d4T-containing regimen has played a crucial role in ART scale-up in resource-limited
settings, due to its availability in a fixed-dose combination and most importantly its low cost. d4T
remains a widely-used ARV in first-line regimens.
In December 2009, WHO released new recommendations for antiretroviral therapy for HIV in adults andadolescents. These new recommendations advise countries to phase out stavudine-based regimens
because of their long term irreversible side effects and to move towards zidovudine or tenofovir-based
first-line regimens. Efavirenz (EFV) is the preferred NNRTI for use in patients starting ART while on TB
treatment.375
Patents Basic patents related to zidovudine (AZT), lamivudine (3TC) or efavirenz (EFV) could not be
obtained in some developing countries such as India, which did not grant product patents on
pharmaceuticals at the time.
This allowed Indian drug companies to manufacture generic versions of the medicines and to develop
this product.
However, GlaxoSmithKline and Merck may hold patents in other developing countries, which could
prevent the importation and use of this fixed-dose combination.

74 • Médecins Sans Frontières • January 2010 • Untangling the Web of ARV Price Reductions • Please check utw.msfaccess.org

Annex 1: Summary of prices in US$ quoted by companies for eligible developing countries
Prices are quoted as per patient year followed in brackets by the smallest unit price.

ABC
300mg tablet
20mg oral solution
60mg tablet
ATV

Daily dose
2
10ml
4

100mg capsule
150mg capsule
200mg capsule
ddl

3
2
--

25mg tablet
50mg tablet
100mg tablet
150mg tablet
200mg tablet
125mg EC capsule
200mg EC capsule
250mg EC capsule
400mg EC capsule
2g powder for reconstitution
DRV
300mg tablet
EFV

5
-4
----1
1
12ml

50mg capsule
50mg tablet
100mg capsule
200mg capsule
200mg tablet
600mg tablet
30mg/ml suspension

---3
3
1
--

4

Cipla
Aurobindo
GSK
261 (0.358)
237 (0.325)
437 (0.599)
230 (0.063/ml) 204 (0.056/ml) 230 (0.063)
183 (0.125)
134 (0.092)
BMS
Emcure
Cat 1

Cat 2

353 (0.484)(0.602)
Aurobindo

431 (0.590)(0.743)207 (0.142)(0.225)(0.283)(0.186)(0.224)172 (0.471)
270 (0.740)
88 (4.000/2g)
Tibotec
1095(0.750)
Aurobindo

Cat 1
212 (0.116)(0.158)310 (0.212)(0.308)(0.425)373 (0.341)
318 (0.435)
378 (0.518)
BMS
Cat 2
433 (0.237)(0.237)366 (0.251)(0.348)Matrix243 (0.333)

Ranbaxy
341 (0.467)

Strides

730 (0.500)

183 (0.125)

Cipla

Ranbaxy

115 (0.063)(0.079)188 (0.129)(0.167)(0.257)228 (0.125)(0.115)242 (0.166)

223 (0.611)
249 (0.683)
103 (0.283)
288 (0.789)
322 (0.881)
132 (0.363)
276(12.590/2g) 308(14.057/2g)

Cipla

EmcureMatrix(0.087)(0.150)152 (0.139)

146 (0.133)

97 (0.267)

107 (0.292)

97 (0.267)

107 (0.292)

Merck
Cat 1
(0.120)(0.120)394 (0.360)
394 (0.360)
237 (0.650)(0.094/ml)

Merck
Merck
Cat 2
(0.210)(0.210)821 (0.750)
821 (0.750)
657 (1.800)(0.151/ml)

Ranbaxy

Strides171 (0.156)
145 (0.397)

128 (0.117)
103 (0.281)

Médecins Sans Frontières • January 2010 • Untangling the Web of ARV Price Reductions • Please check utw.msfaccess.org • 75

FPV
700mg tablet
50mg/ml suspension
FTC
200mg capsule
IDV

Daily dose2
12ml

400mg capsule3TC
150mg tablet
300mg tablet
10mg/ml suspension
NFV

4
2
1
10ml

365 (0.250)
Aurobindo
39 (0.053)
24 (0.067)
29 (0.008/ml)
Cipla

250mg tablet
50mg/g oral powder
NVP

10
24g

945 (0.259)

200mg tablet
10mg/ml suspension
RAL

2
20ml

400mg tablet
RTV
100mg capsule
80mg/ml oral solution
SQV

2200mg hard-capsule
500mg tablet
d4T

10
4

15mg capsule
20mg capsule
30mg capsule
1mg powder for suspension

--2
20ml

1

GSK
1222 (1.674)
648 (0.148/ml)
Aurobindo
67 (0.183)
Aurobindo

Aurobindo2--

42 (0.058)
66 (0.009/ml)
Merck
Cat 1
1113 (1.525)
Abbott83 (0.114)(0.093/ml)
Cipla1621 (0.444)
Aurobindo(0.029)(0.030)22 (0.030)
66 (0.009/ml)

Matrix79 (0.217)
Cipla

MerckMerck
Cat 1
Cat 2
Cat 1
686 (0.470)
394 (0.270)
MatrixGSK
34 (0.046)
64 (0.087)
34 (0.092)422 (0.289)
Cipla
35 (0.048)
41 (0.113)
37 (0.010/ml)
84 (0.023/ml)
Roche
Cat 1
Cat 2
1612 (0.442)
2501 (0.685)
2189 (0.250/g)
2533 (0.289/g)
Boehringer
Cipla
Boehringer
Cat 1
Cat 2
35 (0.048)
219 (0.300)
438 (0.600)
380 (0.052/ml)
533 (0.073/ml) 73 (0.010/ml)

Cipla
313 (0.429)

Ranbaxy
426 (0.292)
Ranbaxy
39 (0.054)

Strides37 (0.050)

EmcureHuahaiMatrixRanbaxy

42 (0.058)

35 (0.048)

42 (0.058)

47 (0.065) 42 (0.057)

MatrixRanbaxy

Strides24 (0.033)

26 (0.035)

22 (0.050)

Strides219 (0.300)

RocheRoche
Cat 1
Cat 2
1249 (0.342)
2501 (0.685)
1146 (0.785)
2499 (1.712)
1533 (1.050) BMSBMS
Cat 1
Cat 2
(0.082)(0.093)(0.089)(0.093)48 (0.066)
68 (0.093)
51 (0.007/ml)
58 (0.008/ml)

Cipla(0.024)(0.025)26 (0.035)
44 (0.006/ml)

76 • Médecins Sans Frontières • January 2010 • Untangling the Web of ARV Price Reductions • Please check utw.msfaccess.org

StridesTDF

Daily dose

Aurobindo

Cipla

300mg tablet
AZT
300mg tablet
100mg capsule
250mg capsule
10mg/ml suspension
ABC/3TC
600/300mg tablet
60/30mg tablet
3TC/d4T
150/30mg tablet
30/6mg dispersible tablet
60/12mg dispersible tablet
LPV/r

1

116 (0.317)
Aurobindo
110 (0.150)(0.092)100 (0.275)
Cipla
97 (0.133)(0.050)73 (0.010/ml)
Aurobindo
157 (0.429)
194 (0.133)
Aurobindo
53 (0.072)

80 (0.011/ml)
Cipla
152 (0.417)

133/33mg soft-gel capsule
200/50mg tablet (heat-stable)
80/20mg solution
100/25mg tablet (heat-stable)
TDF/FTC

644ml
3

300/200mg tablet
TDF/3TC
300/300mg tablet
AZT/3TC
300/150mg tablet
60/30mg tablet
3Tc/d4T/NVP
30/6/50mg dispersible tablet
60/12/100mg dispersible tablet
150/30/200mg tablet
TDF/FTC/EFV

1

300/200/600mg tablet

1

2--20ml
1
4
2
4
2

1
2
4
4
2
2

Cipla
50 (0.068)
47 (0.032)
40 (0.055)
AbbottCat 2
Cat 1
1000 (0.457)
500 (0.228)1000 (0.685)
400 (0.307)
176 (0.121/ml) 400 (0.274/ml)
376 (0.343)
165 (0.151)
Cipla
Aurobindo
164 (0.450)
Cipla
134 (0.367)
Aurobindo
122 (0.167)
146 (0.100)
Aurobindo

152 (0.417)
Matrix134 (0.367)
Cipla
117 (0.160)

82 (0.113)
Cipla

Cipla
61 (0.042)
55 (0.076)
80 (0.110)
Matrix268 (0.733)

268 (0.733)

GileadCat 2
Cat 1
207 (0.567) 365 (1.000)
MatrixGSK
97 (0.133)
161 (0.221)(0.122)(0.276)234 (0.032/ml)
MatrixGSK
484 (1.326)
244 (0.167)
Ranbaxy
Matrix55 (0.075)
49 (0.067)

MatrixStrides116 (0.317)
Ranbaxy
99 (0.135)

149 (0.408)

Strides46 (0.063)

Aurobindo

Cipla

Matrix511 (0.350)

1218 (0.556)
486 (0.353)

486 (0.333)

329 (0.300)
GileadHeteroCat 1
Cat 2
319 (0.875)
548 (1.500)

228 (0.208)
MatrixEmcure91 (0.125)

GSK
197 (0.270)

Ranbaxy
124 (0.170)

EmcureMatrixMatrix122 (0.167)
121 (0.083)
Ranbaxy

93 (0.128)

91 (0.125)

88 (0.121)
85 (0.117)
BMS/Gilead/Merck
110 (0.175)
Cat 1
Cat 2
1033 (2.830)
613 (1.680)

158 (0.433)

Strides146 (0.200)

StridesMédecins Sans Frontières • January 2010 • Untangling the Web of ARV Price Reductions • Please check utw.msfaccess.org • 77

TDF/3TC/EFV
300/300/600mg tablet (FDC)
300/300 + 600mg (Co-pack)
AZT/3TC/ABC
300/150/300mg tablet (FDC)
300/150 + 300mg (Co-pack)
60/30/60mg tablet (FDC)
AZT/3TC/NVP
300/150/200mg tablet
60/30/50mg tablet
3TC/d4T + EFV
150/30 + 600mg (Co-pack)
AZT/3TC + EFV
150/300 + 600mg (Co-pack)

Daily dose
1
1 kit (2 tabs)
2
1 kit (4 tabs)
4
2
4
1 kit (3 tabs)
1 kit (3 tabs)

Cipla
350 (0.959)
Aurobindo

Matrix243 (0.667)
Cipla
414 (0.567)

GSK
653 (0.895)

Aurobindo
158 (0.217)

Cipla
151 (0.207)

Cipla
274 (0.751)
Aurobindo
286 (0.783)

Ranbaxy
345 (0.945)
Cipla
320 (0.877)

Matrix158 (0.217)
158 (0.108)
Strides176 (0.483)
Ranbaxy
434 (1.190)

Matrix365 (0.500)

402 (1.100)
244 (0.167)
Ranbaxy183 (0.250)

Strides249 (0.683

78 • Médecins Sans Frontières • January 2010 • Untangling the Web of ARV Price Reductions • Please check utw.msfaccess.org

Ranbaxy
639 (0.875)

Annex 2: Conditions of offer by company
Company

Eligibility (countries)

Eligibility (bodies)

AbbottCategory 1 countries:
All African countries and all United Nations
defined least developed countries outside
Africa.
Category 2 countries:
See Annex 8 for more details.

Governments and programs fully funded bygovernments, UN systems organizations,
NGOs and other not-for-profit institutional
providers in low and low-middle-income
countries.

Aurobindo

No reported restrictions.

NGOs and governmental organisations.

Additional comments

Delivery of goods
FOB.

FOB prices, freight & insurance extra
as per country & mode - Air or Sea

Payment by letter of credit orAdvance payment.

Prices available for above 300,000
units for tablet packs and above 3,000
packs for oral solutions.

FOB Hyderabad (India).

Delivery of goods 4-6 weeks from thedate of confirmed orders.
Bristol-Myers Squibb

Category 1 countries:
Sub-Saharan African countries (except southern
African countries) plus countries classified as
low-income by the World Bank (except Korea,
Kyrgyzstan, Moldova and Uzbekistan).

Both private and public sector
organisations that are able to provide
effective, sustainable and medically-soundcare and treatment of HIV/AIDS.

Category 1 countries are invoiced in
US$.

CIP incoterm.

Category 2 countries are invoiced inSouth African Rand.

Category 2 countries:
Southern African countries
See annex 7 for more details.
For other developing countries, prices arenegotiated on a case-by-case basis with BMS
local representatives.
Boehringer Ingelheim

Category 1 countries:
All LDCs, all low income countries and all of
AfricaGovernments, NGOs and other partners
who can guarantee that the programme is
run in a responsible manner.

CIF.

Category 2 countries:
All middle-income countries not included in
category 1
Cipla

No reported restrictions but higher prices havebeen negotiated separately for ten Latin
American countries.

No restrictions.

No quantity-related conditions. Prices
for larger quantities are negotiable.

FOB Mumbai (India) or CIF Freight charges separately on
actual.

Médecins Sans Frontières • January 2010 • Untangling the Web of ARV Price Reductions • Please check utw.msfaccess.org • 79

Company

Eligibility (countries)

Eligibility (bodies)

GileadOver 125 countries are eligible, including all
African countries and additional countries
classified as low- or lower-middle-income by
the World Bank. See Annex 9 for more details.

Organisations that provide HIV treatment
The programme is managed throughin the more than 125 countries are covered Gilead International Access Operations
by the Gilead Access Program.
and Gilead's local distribution partners.
Please note that local taxes, tariffs,
For organisations in Africa enquiries should and limited distributor mark-ups may
be directed to Jennifer Watt:be added to the ex-factory prices.
jwatt@gilead.com or +44 20 8587 2228.

For other developing countries, prices arenegotiated on a case-by-case basis.

Additional comments

Delivery of goods
Shipping terms vary by local
distributor.

All other enquiries should be directed toAccess@gilead.com or via telephone at+1 650 522 5101.
Additional information is available at:www.gilead.com.
GlaxoSmithKline

Least Developed Countries (LDCs) plus subSaharan Africa.
All Country Coordination Mechanisms (CCM)
projects fully financed by the Global Fund toFight AIDS, TB and Malaria, as well as projects
funded by PEPFAR.
For other low- and middle-income countries,
public sector prices are negotiated on a caseby-case basis, either bilaterally or through the
Accelerating Access Initiative.

Governments, aid organisations, charities,
UN agencies, other not-for-profit
organisations and international
procurement agencies.

Supply Agreement required (for NGOs
requiring fewer than ten patient packs
per month, this requirement may be
waived).

In sub-Saharan Africa, employers offering
HIV/AIDS care and treatment directly totheir uninsured staff through workplaceclinics or similar arrangements.

All organisations must supply thepreferentially priced products on a notfor-profit basis.

CIP.

HuahaiNo reported restrictions.

Governments, non-profit institutional
providers of HIV care, NGOs, and otherprivate and public organisations that areable to provide responsible, sustainable
and medically sound care.

For final purchase, price will be further
negotiated, considering the factors likechanges in exchange rate.

FCA Shanghai.

MatrixNo reported restrictions except Belarus, Cuba,
Democratic Republic of Congo, Iran, Liberia,
Sudan and Syria for which prior approval from
Mylan Labs Inc is required

No restrictions.

None.

Ex-works Nashik, India or as
specified by customers.

Merck

Please refer to Annex 10 for the individual drug
country eligibility.

Governments, international organisations,NGOs, private sector organisations (e.g.
employers, hospitals and insurers).

Merck may under certain circumstances
supply ARVs to patients through retailpharmacies.

CIP.

Ranbaxy

No reported restrictions, but higher prices werenegotiated separately for ten Latin Americancountries.

NGOs and governments or programmes
supported by them.

Confirmed letter of credit or advancepayment preferred for new customers.

FCA Delhi (India).

80 • Médecins Sans Frontières • January 2010 • Untangling the Web of ARV Price Reductions • Please check utw.msfaccess.org

Company

Eligibility (countries)

Eligibility (bodies)

Additional comments

Delivery of goods

Roche

Category 1 countries:
All countries in sub-Saharan Africa and all
countries classified as Least Developed Countries
by the United Nations.

Governments, non-profit institutional
providers of HIV care, NGOs.

CAD (Cash Against Documents) 30
days at sight. Minimum order anddelivery amount per shipment is CHF
10,000.

FCA Basel airport (Switzerland)or CIP airport of destination.

Governments, non-profit institutional
providers of HIV treatment, NGOs.

Payment by signed letter of credit.

FOB Bangalore (India).

Category 2 countries:
Low-income and lower middle-income countries,
as classified by the World Bank.
Strides

No reported restrictions.

Notes:
The conditions detailed in the table above were those quoted directly by the companies. Definitions of eligibility vary from company to company. Each originator company establishes different restrictions to their offer of reduced
prices, and classifies countries according to different categories. Some companies resort to Least Developed Country (LDC) criteria developed by the United Nations, others to the UN Development Programme's Human
Development Index (UNDP HDI), and others still to World Bank classifications concerning country income.
This lack of uniformity leads to significant differences in the eligibility of a country for different products.
For complete details please refer to annexes 3-10.

Médecins Sans Frontières • January 2010 • Untangling the Web of ARV Price Reductions • Please check utw.msfaccess.org • 81

Annex 3: Least Developed
Countries (LDCs)
Source: United Nations
http://www.un.org/special-rep/ohrlls/ldc/list.htm
Fifty countries are currently designated by theUnited Nations as least-developed countries(LDCs).
Afghanistan; Angola; Bangladesh; Benin;
Bhutan; Burkina Faso; Burundi; Cambodia;
Central African Republic; Chad; Comoros;
Congo (Democratic Republic); Djibouti;
Equatorial Guinea; Eritrea; Ethiopia; Gambia;
Guinea; Guinea-Bissau; Haiti; Kiribati; Lao PDR;
Lesotho; Liberia; Madagascar; Malawi;
Maldives; Mali; Mauritania; Mozambique;
Myanmar; Nepal; Niger; Rwanda; Samoa; São
Tomé and Principe; Senegal; Sierra Leone;
Solomon Islands; Somalia; Sudan; Tanzania;
Timor-Leste; Togo; Tuvalu; Uganda; Vanuatu;
Yemen; Zambia.

Annex 4: Human Development
Index (HDI)
Source: United Nations Development
Programme (UNDP)
http://hdr.undp.org/en/media/hdr_20072008_en_complete.pdf
The Human Development Index is publishedannually as a part of UNDP's annual Human
Development Report.
Low human development:
Afghanistan, Angola; Benin; Burkina Faso;
Burundi; Central African Republic; Chad; Congo(Democratic Republic); Côte d'Ivoire; Eritrea;
Ethiopia; Gambia; Guinea; Guinea-Bissau;

Liberia; Malawi; Mali; Mozambique; Niger;
Nigeria; Rwanda; Senegal; Sierra Leone;
Tanzania; Timor-Leste; Togo; Zambia.
Medium human development:
Algeria; Angola; Armenia; Azerbaijan;
Bangladesh; Belize; Bhutan; Bolivia; Botswana;
Cambodia; Cameroon; Cape Verde; China;
Comoros; Congo; Djibouti; Dominican Republic;
Egypt; El Salvador; Equatorial Guinea; Fiji;
Gabon; Georgia; Ghana; Guatemala; Guyana;
Haiti; Honduras; India; Indonesia; Iran; Jamaica;
Jordan; Kenya; Kyrgyzstan; Lao PDR; Lesotho;
Madagascar; Maldives; Mauritania; Moldova;
Mongolia; Morocco; Myanmar; Namibia; Nepal;
Nicaragua; Nigeria; Pakistan; Occupied
Palestinian Territories; Papua New Guinea;
Paraguay; Philippines; St. Vincent and the
Grenadines; Samoa; São Tomé and Principe;
Solomon Islands; South Africa; Sri Lanka;
Sudan; Suriname; Swaziland; Syrian Arab
Republic; Tanzania; Tajikistan; Thailand; Tonga;
Tunisia; Turkmenistan; Uganda; Ukraine;
Uzbekistan; Vanuatu; Viet Nam; Yemen.

Annex 5: Sub-Saharan countries
Source: World Bank country classification
http://web.worldbank.org/WBSITE/EXTERNAL/DATASTATISTICS/0,,contentMDK:20421402~pageP
K:64133150~piPK:64133175~theSitePK:239419,
00.html#Sub_Saharan_Africa
Angola; Benin; Botswana; Burkina Faso;
Burundi; Cameroon; Cape Verde; Central
African Republic; Chad; Comoros; Congo;
Congo (Democratic Republic); Côte d'Ivoire;
Eritrea; Ethiopia; Gabon; Gambia; Ghana;
Guinea; Guinea-Bissau; Kenya; Lesotho;
Liberia; Madagascar; Malawi; Mali; Mauritania;
Mauritius; Mayotte; Mozambique; Namibia;
Niger; Nigeria; Rwanda; São Tomé andPrincipe; Senegal; Seychelles; Sierra Leone;
Somalia; South Africa; Sudan; Swaziland;
Tanzania; Togo; Uganda; Zambia; Zimbabwe.

Annex 6: World Bank classificationof economies
Source: World Bank
http://web.worldbank.org/WBSITE/EXTERNAL/D
ATASTATISTICS/0,,contentMDK:20421402~page
PK:64133150~piPK:64133175~theSitePK:23941
9,00.html
The list is updated every year on 1st July. Thisversion is effective from 1st July 2009.
Low-income economies:
Afghanistan; Bangladesh; Benin; Burkina Faso;
Burundi; Cambodia; Central African Republic;
Chad; Comoros; Congo (Democratic Republic);
Côte d'Ivoire; Eritrea; Ethiopia; Gambia;
Ghana; Guinea; Guinea-Bissau; Haiti; Kenya;
Korea (Democratic Republic); Kyrgyzstan; Lao
PDR; Liberia; Madagascar; Malawi; Mali;
Mauritania; Mozambique; Myanmar; Nepal;
Niger; Nigeria; Pakistan; Papua New Guinea;
Rwanda; São Tomé and Principe; Senegal;
Sierra Leone; Solomon Islands; Somalia;
Tajikistan; Tanzania; Togo; Uganda;
Uzbekistan; Vietnam; Yemen; Zambia;
Zimbabwe.
Lower middle-income economies:
Albania; Algeria; Angola; Armenia; Azerbaijan;
Bhutan; Bolivia; Bosnia and Herzegovina;
Cameroon; Cape Verde; China; Colombia;
Congo; Djibouti; Dominican Republic;
Ecuador; Egypt; El Salvador; Georgia;
Guatemala; Guyana; Honduras; India;
Indonesia; Iran; Iraq; Jordan; Kiribati; Lesotho;
Macedonia; Maldives; Marshall Islands;
Micronesia; Moldova; Mongolia; Morocco;

82 • Médecins Sans Frontières • January 2010 • Untangling the Web of ARV Price Reductions • Please check utw.msfaccess.org

Namibia; Nicaragua; Paraguay; Peru;
Philippines; Samoa; Sri Lanka; Sudan;
Swaziland; Syria; Thailand; Timor-Leste; Tonga;
Tunisia; Turkmenistan; Ukraine; Vanuatu; WestBank and Gaza.
Upper middle-income economies:
American Samoa; Argentina; Belarus; Belize;
Botswana; Brazil; Bulgaria; Chile; Costa Rica;
Croatia; Cuba; Dominica; Fiji; Gabon; Grenada;
Jamaica; Kazakhstan; Latvia; Lebanon; Libya;
Lithuania; Malaysia; Mauritius; Mayotte;
Mexico; Palau; Panama; Poland; Romania;
Russian Federation; Serbia and Montenegro;
Seychelles; South Africa; St. Kitts and Nevis;
St. Lucia; St. Vincent and the Grenadines;
Suriname; Turkey; Uruguay; Venezuela.

Annex 7: Bristol-Myers Squibb
eligible countries
1st Category Countries:
Afghanistan; Angola; Bangladesh; Benin;
Bhutan; Burkina Faso; Burundi; Cambodia;
Cameroon; Cape Verde; Central African
Republic; Chad; Comoros; Congo; Congo(Democratic Republic); Côte d'Ivoire; Djibouti;
Equatorial Guinea; Eritrea; Ethiopia; Gabon;
Gambia; Ghana; Guinea; Guinea-Bissau; Haiti;
India; Kenya; Lao PDR; Liberia; Madagascar;
Mali; Mauritania; Mauritius; Mongolia;
Myanmar; Nepal; Nicaragua; Niger; Nigeria;
Pakistan; Papua New Guinea; Rwanda; São
Tomé and Principe; Senegal; Seychelles; Sierra
Leone; Solomon Islands; Somalia; Sudan;
Tanzania; Timor-Leste; Togo; Tuvalu; Uganda;
Viet Nam; Yemen.

2nd Category Countries: Southern Africancountries
Botswana; Lesotho; Malawi; Mozambique;
Namibia; South Africa; Swaziland; Zambia;
Zimbabwe.

Kazakhstan; Marshall Islands; Micronesia;
Moldova; Nicaragua; Paraguay; Peru;
Philippines; Serbia and Montenegro; Sri Lanka;
Suriname; Syria; Thailand; The FYR-Macedonia;
Tonga; Turkmenistan; Ukraine

Annex 8: Abbott eligible countries
Source: Abbott's Access to HIV Care Program
1st Category Countries: Africa and Leastdeveloped countries
Afghanistan; Algeria; Angola; Bangladesh;
Benin; Bhutan; Botswana; Burkina Faso;
Burundi; Cambodia; Cameroon; Cape Verde;Central African Republic; Chad; Comoros;
Congo-Brazzaville; Côte d'Ivoire; Dem Rep ofCongo; Djibouti; East Timor; Egypt; Equatorial
Guinea; Eritrea; Ethiopia; Gabon; Gambia;
Ghana; Guinea; Guinea-Bissau; Haiti; Kiribati;
Kenya; Laos; Lesotho; Liberia; Libya;
Madagascar; Malawi; Maldives; Mali;
Mauritania; Mauritius; Morocco; Mozambique;
Myanmar; Namibia; Nepal; Niger; Nigeria;
Rwanda; Samoa; São Tomé and Principe;
Senegal; Seychelles; Sierra Leone; Solomon
Islands; Somalia; South Africa; Sudan;
Swaziland; Tanzania; Togo; Tunisia; Tuvalu;
Uganda; Vanuatu; Yemen; Zambia; Zimbabwe.
2nd Category Countries:
Low Income economies (excluding Africa andthe LDC as defined by the UN) India;
Kyrgyzstan; Mongolia; Pakistan; Papua New
Guinea; Tajikistan; Uzbekistan; Vietnam
Lower Middle Income economies (excluding
Africa and the LDC as defined by the UN)
Albania; Armenia; Azerbaijan; Belarus; Bolivia;
Bosnia and Herzegovina; Brazil; China;
Colombia; Dominican Republic; Ecuador, El
Salvador; Fiji; Georgia; Guatemala; Guyana;
Honduras; Indonesia; Jamaica; Jordan;

Annex 9: Gilead eligible countries
Source: Gilead Access Program
http://www.gilead.com
1st Category Countries: Low-Income Pricing
Tier
Afghanistan; Algeria; Angola; Anguilla; Antigua
and Barbuda; Bahamas; Bangladesh;
Barbados; Belize; Benin; Bhutan; Bolivia;
Botswana; British Virgin Islands; Burkina
Faso; Burundi; Cambodia; Cameroon; Cape
Verde; Central African Republic; Chad;
Comoros; Congo; Congo, Dem. Rep. of; Côte
d'Ivoire; Cuba; Djibouti; Dominica; Dominican
Republic; Egypt; Equatorial Guinea; Eritrea;
Ethiopia; Gabon; Gambia; Ghana; Grenada;
Guatemala; Guinea; Guinea-Bissau; Guyana;
Haiti; Honduras; India; Indonesia; Jamaica;
Kenya; Kiribati; Kyrgyzstan; Lao, People'sDem. Rep.; Lesotho; Liberia; Libya;
Madagascar; Malawi; Maldives; Mali;
Mauritania; Mauritius; Moldova; Mongolia;
Montserrat; Morocco; Mozambique; Myanmar;
Namibia; Nauru; Nepal; Nicaragua; Niger;
Nigeria; Pakistan; Palau; Panama; Papua New
Guinea; Rwanda; St. Kitts and Nevis; St.
Lucia; St. Vincent and the Grenadines;
Samoa; São Tomé and Principe; Senegal;
Seychelles; Sierra Leone; Solomon Islands;
Somalia; South Africa; Sudan; Suriname;
Swaziland; Syria; Tajikistan; Tanzania, U. Rep.
of; Timor-Leste; Togo; Trinidad and Tobago;
Tunisia; Turks and Caicos; Tuvalu; Uganda;
Ukraine; Uzbekistan; Vanuatu; Vietnam;
Yemen; Zambia; Zimbabwe.

2nd Category Countries: Lower Middle-Income
Pricing Tier
Albania; Armenia; Azerbaijan; Belarus; Bosnia
and Herzegovina; China; Ecuador; El Salvador;
Fiji; Georgia; Iran; Iraq; Jordan; Kazakhstan;Montenegro; Paraguay; Peru; Philippines;
Serbia; Sri Lanka; Thailand; Tonga;
Turkmenistan.

Annex 10: Merck eligible countries
Source: The following lists and notes are fromcorrespondence with Merck & Co.
Merck's Pricing Policy for efavirenz andindinavir
1st Category Countries:
Afghanistan; Angola; Anguilla; Antigua andBarbuda; Bangladesh; Belize; Benin; Bhutan;
Botswana*; Burkina Faso; Burundi; Cambodia;
Cameroon; Cape Verde; Central African
Republic; Chad; Comoros; Congo; Congo DRC;
Côte d'Ivoire; Djibouti; Dominica; DominicanRep.; Equatorial Guinea; Eritrea; Ethiopia;
Gabon; Gambia; Ghana; Grenada; Guatemala;Guinea-Bissau; Guinea; Guyana; Haiti;
Honduras; Jamaica; Kenya; Kiribati; Lao PDR.;
Lesotho; Liberia; Madagascar; Malawi;
Maldives; Mali; Mauritania; Moldova;
Mozambique; Myanmar; Namibia; Nepal;
Niger; Nigeria; Pakistan; Panama; Papua New
Guinea; Romania**; Russia; Rwanda; São
Tomé and Principe; Senegal; Sierra Leone;
Solomon Islands; Somalia; South Africa; St.
Kitts and Nevis; St. Lucia; St. Vincent and the
Grenadines; Sudan; Suriname; Swaziland;
Tanzania; Thailand; Timor-Leste; Togo;
Trinidad and Tobago; Tuvalu; Uganda;
Ukraine; Vanuatu; Western Samoa; Yemen;Zambia; Zimbabwe.

2nd Category Countries:
Albania; Algeria; Armenia; Azerbaijan; Belarus;
Bolivia; Bosnia Herzegovina; Brazil; Bulgaria;
China; Colombia; Costa Rica; Ecuador; Egypt;
El Salvador; Estonia; Fiji; Georgia; India;
Indonesia; Iran; Jordan; Kazakhstan;
Kyrgyzstan; Latvia; Lebanon; Libya; Lithuania;
Macedonia; Malaysia; Mauritius; Mexico;
Mongolia; Morocco; Nicaragua; Oman;
Palestinian Territories; Paraguay; Peru;
Philippines; Saudi Arabia; Seychelles; Sri
Lanka; Syria; Tajikistan; Tunisia; Turkey;
Turkmenistan; Uzbekistan; Venezuela; VietNam.

NOTES:
Both the UNCTAD and UNDP HDI lists are themost current. UNCTAD list was most recently
updated and published in June 2007. UNDP
HDI was last updated and published in
November 2007.
* In Botswana, Merck provides indinavir andefavirenz free of charge.
** Due to a special partnership in Romania,
Merck provides indinavir and efavirenz at a
'no-profit price'.
The following countries are neither on the
UNCTAD LDC list nor located in Sub-SaharanAfrica. They have not been given a country
classification (low, medium or high) by the
UNDP. Inquiries about pricing for thesecountries will be handled on a case-by-casebasis: Iraq, Marshall Islands, Micronesia,
Montenegro, Nauru, North Korea (DPR) and
Palau.
Merck's Pricing Policy for raltegravir
1st Category Countries:
Afghanistan; Angola; Bangladesh; Benin;
Bhutan; Botswana; Burkina Faso; Burundi;
Cambodia; Cameroon; Cape Verde; Central
African Republic; Chad; Comoros; Congo;

Médecins Sans Frontières • January 2010 • Untangling the Web of ARV Price Reductions • Please check utw.msfaccess.org • 83

Congo DRC; Côte d'Ivoire; Djibouti; Equatorial
Guinea; Eritrea; Ethiopia; Gabon; Gambia;
Ghana; Guinea-Bissau; Guinea; Haiti; Kenya;
Kiribati; Lao PDR.; Lesotho; Liberia;
Madagascar; Malawi; Maldives; Mali;
Mauritania; Mozambique; Myanmar; Namibia;
Nepal; Niger; Nigeria; Rwanda; São Tomé andPrincipe; Senegal; Sierra Leone; Solomon
Islands; Somalia; South Africa; Sudan;
Swaziland; Tanzania; Timor-Leste; Togo; Tuvalu;
Uganda; Vanuatu; Western Samoa; Yemen;Zambia; Zimbabwe.
2nd Category Countries:
Algeria; Armenia; Azerbaijan; Belize; Bolivia;
Brazil**; China; Colombia; Dominica;
Dominican Rep.; Ecuador; Egypt; El Salvador;
Fiji; Georgia; Grenada; Guatemala; Guyana;
Honduras; India; Indonesia; Iran; Jamaica;
Jordan; Kazakhstan; Kyrgyzstan; Lebanon;
Moldova; Mongolia; Morocco; Nicaragua;
Pakistan; Palestinian Territories; Peru;
Philippines; St. Lucia; St. Vincent and the
Grenadines; Sri Lanka; Suriname; Syria;
Tajikistan; Thailand; Tunisia; Turkey;
Turkmenistan; Ukraine; Uzbekistan; Venezuela;
Viet Nam.

NOTES:
Both the UNCTAD and UNDP HDI lists are themost current. UNCTAD list was most recently
updated and published in June 2007. UNDP
HDI was last updated and published in
November 2007. Countries in Sub-SaharanAfrica not on the UNCTAD list of Least
Developed Countries (LDC) but whose public
sectors are eligible for Tier I pricing.
* In Botswana, Merck provides raltegravir freeof charge.
** Merck notes that Brazil "receives significant
reduced pricing due to extraordinarycommitment in treating HIV/AIDS patients."

The following countries are neither on the
UNCTAD LDC list nor located in Sub-SaharanAfrica. They have not been given a country
classification (low, medium or high) by the
UNDP. Inquiries about pricing for thesecountries will be handled on a case-by-casebasis: Iraq, Marshall Islands, Micronesia,
Montenegro, Nauru, North Korea (DPR) and
Palau.
Merck's Pricing Policy for TDF/FTC/EFV
300/200/600mg
1st Category Countries:
Afghanistan; Angola; Antigua and Barbuda;
Bangladesh; Belize; Benin; Bhutan; Botswana*;
Burkina Faso; Burundi; Cambodia; Cameroon;
Cape Verde; Central African Republic; Chad;
Comoros; Congo; Congo DRC; Côte d'Ivoire;
Djibouti; Dominica; Dominican Rep.; Equatorial
Guinea; Eritrea; Ethiopia; Gabon; Gambia;
Ghana; Grenada; Guatemala; Guinea-Bissau;
Guinea; Guyana; Haiti; Honduras; Jamaica;
Kenya; Kiribati; Lao PDR; Lesotho; Liberia;
Madagascar; Malawi; Maldives; Mali;
Mauritania; Moldova; Mozambique; Myanmar;
Namibia; Nepal; Niger; Nigeria; Pakistan;
Panama; Papua New Guinea; Rwanda; São
Tomé and Principe; Senegal; Sierra Leone;
Solomon Islands; Somalia; South Africa; St.
Kitts and Nevis; St. Lucia; St. Vincent and the
Grenadines; Sudan; Suriname; Swaziland;
Tanzania; Timor-Leste; Togo; Trinidad andTobago; Tuvalu; Uganda; Ukraine; Vanuatu;
Western Samoa; Yemen; Zambia; Zimbabwe.

NOTES:
Both the UNCTAD and UNDP HDI lists are themost current. UNCTAD list was most recently
updated and published in June 2007. UNDP
HDI was last updated and published in
November 2007.
* In Botswana, Merck provides TDF/FTC/EFV freeof charge.
The following countries are neither on the
UNCTAD LDC list nor located in Sub-SaharanAfrica. They have not been given a country
classification (low, medium or high) by the
UNDP. Inquiries about pricing for thesecountries will be handled on a case-by-casebasis: Iraq, Marshall Islands, Micronesia,
Montenegro, Nauru, North Korea (DPR) and
Palau.

2nd Category Countries:
Bolivia; Indonesia; Kyrgyzstan; Mauritius;
Mongolia; Nicaragua; Seychelles; Syria;
Tajikistan; Uzbekistan; Viet Nam.

84 • Médecins Sans Frontières • January 2010 • Untangling the Web of ARV Price Reductions • Please check utw.msfaccess.org

Annex 11: Suggested resources for further information:• WHO Registration http://ftp.who.int/htm/AMDS/drugsdatabase.pdf

For documentation on prices quoted by companies:• WHO Antiretroviral Therapy for HIV Infection in Adults and Adolescents: Recommendations for a
public http://www.who.int/hiv/pub/guidelines/artadultguidelines.pdf• Back issues of Untangling the web of price reductions: a pricing guide for the purchase of ARVs
for developing countries, can be found at: www.msfaccess.org• Sources and Prices of Selected Medicines and Diagnostics for People Living with HIV/AIDS (June2005) http://www.who.int/medicines/areas/access/med_prices_hiv_aids/en/index.html• Global HIV/Aids Epidemic Selection of Antiretroviral Medications Provided under U.S. Emergency
Plan Is Limited, January 2005: http://pdf.dec.org/pdf_docs/Pcaab266.pdf
For documentation on prices reported by countries:• WHO Global Price Reporting Mechanism http://www.who.int/3by5/amds/price/hdd/• Antiretroviral Therapy for HIV Infection in Infants and Children:Towards Universal Access:Recommendations for a public health approach 2007.
http://www.who.int/hiv/pub/guidelines/paediatric020907.pdf• UNICEF Procurement of HIV/AIDS Related Supplies. September 2007
http://www.unicef.org/supply/files/Procurement_of_HA_supplies(1).pdf• Biotechnology/Pharmaceuticals HIV/AIDS Industry Report - April 2005
http://www.aethlonmedical.com/pdfs/IndustryReport.pdf• Clinton Foundation Antiretroviral Price List
http://www.clintonfoundation.org/pdf/chai-arv-price-list-050807.pdf• Access Campaign web site http://www.msfaccess.org• The Global Fund Price Reporting Mechanism
http://www.theglobalfund.org/en/funds_raised/price_reporting/default.asp• Management Sciences for Health (MSH) International Drug Price Indicator Guide
http://erc.msh.org/mainpage.cfm?file=1.0.htm&id=1&temptitle=Introduction&module=DMP&languag
e=English#top• WHO AFRO region Essential Medicines Price Indicator
http://www.who.int/medicines/publications/afro-essential_med_price_indicator_nocover.pdf
For documentation on patents:• “Determining the patent status of essential medicines in developing countries”, Health Economies andDrugs, EDM Series No. 17, UNAIDS/WHO/MSF, 2004.
http://mednet2.who.int/sourcesprices/DeterminingEssMedPatentStatusW_Depliant.pdf• HIV/AIDS medicines and related supplies: Contemporary context and procurement. Technical guide.
Chapter 2 and Annex B. World Bank, Washington, DC, 2004
http://siteresources.worldbank.org/INTPROCUREMENT/Resources/Technical-Guide-HIV-AIDS.pdf• “Drug patents under the spotlight. Sharing practical knowledge about pharmaceutical patents” MSF,
June 2004. http://www.who.int/3by5/en/patents_2003.pdf• Knowledge Ecology International http://www.keionline.org, or http://www.cptech.org/ip/health/
For documentation on quality:• Prequalification Programme managed by the World Health Organization (WHO)http://mednet3.who.int/prequal/• US Food and Drug Administration (FDA) Tentative Approvals http://www.fda.gov/cder/ogd/approvals/
Other useful websites referenced in this document:• International Dispensary Association (IDA) Price Indicator
http://www.idafoundation.org/documents/ida_hiv_aids_aug_07_zondersnijlijnen.pdf• US Food and Drug Administration Orange Book http://www.fda.gov/cder/ob/

utw.msfaccess.org
We're delighted to announce the launch of an online version of Untangling
the Web of Antiretroviral Price Reductions, Médecins Sans Frontières' guideto the prices of AIDS medicines, now in its 12th edition.
The online version reproduces the features of Untangling the Web - ananalysis of the access to antiretrovirals environment, individual drug profile
pages with prices quoted by companies, charts representing the evolution
in price in previous years, and a spotlight on access issues including a lookat patents and paediatrics - in a clear, user-friendly and free-flowing design.

• Catalogue of US Food and Drug Administration Approved Drug Products
http://www.accessdata.fda.gov/scripts/cder/drugsatfda/
Médecins Sans Frontières • January 2010 • Untangling the Web of ARV Price Reductions • Please check utw.msfaccess.org • 85

Annex 12: Company contacts
Abbott:Rob Dintruff
HIV/Access Department
Abbott Laboratories, Abbott Place
219 Golf Club Terrace, Constantia Kloof 1719,
Johannesburg, South Africa
Tel: +27 11 858 2000
E-mail: rob.dintruff@abbott.com
Aurobindo:
Sharadd Jain
GM International Sales (Formulation)
Aurobindo Pharma Limited
Survey # 313, Bachupally, Qutubullapur Mandal
Hyderabad-500072, India
Tel: +91 40 23044060 Ext 515 (Office)E-mail: jainsharadd@aurobindo.com
Website: http://www.aurobindo.com
Boehringer Ingelheim:
Philip BaumCD Communications
Tel: +49 6132 77-2459
Fax: +49 6132 77-3829
E-mail: philipp.baum@ing.boehringeringelheim.com
Michael Rabbow
HIV Policy and Public Affairs
CD Communications
Tel: + 49 6132 77- 92701
Fax: + 49 6132 77-38 29
E-mail: michael.rabbow@ing.boehringeringelheim.com
Bristol-Myers Squibb:
All countries with the exception of Southern
Africa:Mrs Marie-Astrid Mercier,
Coordinator, Global access program,

BMS office: Paris
E-mail: marie-astrid.mercier@bms.com
Southern Africa:
BMS office: Johannesburg
Mr Archie Smuts
Tel: +27 11 456 65 27
E-mail: archie.smuts@bms.com
Cipla:
Mr. Sanjeev Gupte
General Manager-Exports Cipla Limited
Tel: +91 22 23021397 (Direct) 23095521
23092891
Fax: +91 22 23070013/23070393/23070385
E-mail: exports@cipla.com, ciplaexp@cipla.com
Emcure:U. Devbalaji
Director - Global HIV/AIDS Initiatives
255/2, Rajiv Gandhi IT Park,
Hinjwadi, Pune 411057
Tel: +91-20-39821004
E-mail: BalajiUD@emcure.co.in
Gilead:Jennifer Watt
International Access Operations
Gilead Sciences Europe Ltd
2 Roundwood Avenue, Stockley Park
Uxbridge UB11 1AZ, United Kingdom
E-mail: jwatt@gilead.com
Tel: +44 20 8587 2228
GlaxoSmithKline:
JJon Pender
Director Government Affairs, Access Issues, IP& HIV/AIDS
Government Affairs, Europe and Corporate
GlaxoSmithKline
980 Great West Road, Brentford,
Middx. TW8 9GS. UK

tel: + 44 20 8047 5489
fax: +44 20 8047 6957
E-mail: jon.d.pender@gsk.com
Huahai:Mr. Cai Min Da
Vice General Manager
Xunqiao, Linhai, Zhejiang 317024, China+86 576 8599 1657(Headquarters);+86 21 5308 6386 (Shanghai office)E-mail: cai@huahaipharm.com
Matrix:Avrind Kanda
General Manager, Business Development
Anti Retroviral Finished Dosages
Matrix Laboratories Limited
1-1-151/1, V Floor, Sairam Towers
Alexander Road, Secunderabad - 500003
Andhra Pradesh, India
Tel: +91 40 27700363
Fax: + 91 99482 20256
Sunil GaurBusiness Development
Matrix Laboratories Limited
1-1-151/1, VI Floor. Sairam Towers
Alexander Road Secunderabad - 500003
Andhra Pradesh, India
Tel: +91 40 27700363 or + 91 40 55327722
Cell: +91 9948092653
Fax: +91 40 66336401
Merck:
Brenda Colatrella
Executive Director, Corporate Responsibility &Global Policy Support, Merck & Co., Inc.
One Merck Drive, PO Box 100
Whitehouse Station, NJ 08889-0100 USA
Tel: +1-908-423-2047
Fax: +1-908-735-1839
E-mail: brenda_colatrella@merck.com

86 • Médecins Sans Frontières • January 2010 • Untangling the Web of ARV Price Reductions • Please check utw.msfaccess.org

Ranbaxy:
Atul Chhabra
Senior Manager - ARV Business
Ranbaxy Laboratories Limited
Plot No.-90, Sector-32 (NH-8)
Gurgaon - 122001 INDIA
Tel: +91 124 4185917
Fax: +91 124 4106489
Mobile: +91 9899112171
E-mail: atul.chhabra@ranbaxy.com
Roche:
Sandra Torriani
Demand Manager
PTGS-O
F.Hoffmann-La Roche Ltd. Basel
Building 237/2.17
CH 4303 Switzerland
Tel + 41 61 688 9390
Fax: + 41 61 687 1815
E-mail: Sandra.torriani_caccato@roche.com
Website: http://ptb.roche.com/ptb/ptbs/
Strides:
Mrs. Aloka Sengupta
Vice President - AIDS/Tuberculosis/Malaria
Strides House, Bilekahalli
Bannerghatta Road
Bangalore 560 076,
India
Tel: +91-80-66580748
Mobile : +91 98450 24470
Fax: +91-80-66580800
E-mail: aloka.sengupta@stridesarco.com
Tibotec:
Luc Denys
Senior Director
Worldwide Access Programs, Virology
Tibotec- Virco Comm. Va
Tel.: +32(0)15.461.018
Fax.: +32(0)15.401.259
Mobile: +32(0)479.96.43.42

Annex 13: The Clinton Foundation ARV list

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88 • Médecins Sans Frontières • January 2010 • Untangling the Web of ARV Price Reductions • Please check utw.msfaccess.org

Médecins Sans Frontières • January 2010 • Untangling the Web of ARV Price Reductions • Please check utw.msfaccess.org • 89

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Abbreviations

3TC lamivudine; nucleoside analogue
reverse transcriptase inhibitor.
ABC abacavir; nucleoside analogue reverse
transcriptase inhibitor.
AIDS Acquired Immune Deficiency
Syndrome
ALP AIDS Law Project
ANVISA Agência Nacional de Vigilância
Sanitária (National Health Surveillance
Agency Brazil)
API active pharmaceutical ingredient
ARIPO African Regional Intellectual
Property Organisation. There are currently
sixteen states which are party to the
Lusaka Agreement and therefore membersof ARIPO. These are: Botswana, theGambia, Ghana, Kenya, Lesotho, Malawi,
Mozambique, Namibia, Sierra Leone,
Somalia, Sudan, Swaziland, Tanzania,
Uganda, Zambia and Zimbabwe (Total: 16
Member States).
ARV Antiretroviral drug
ATV atazanavir, protease inhibitor
AZT zidovudine (also abbreviated to ZDV),
nucleoside analogue reverse transcriptase
inhibitor.
BI Boehringer Ingelheim.
BMS Bristol-Myers Squibb
Category 1 In this document, 'Category 1'
is used to describe those countries thatare eligible for the most discounted priceoffered by a company.
Category 2 In this document, 'Category 2'
is used to describe those countries thatare not eligible for the lowest prices
reserved for category 1 countries, but arenevertheless offered a discount bycompanies. Crucially, this discount isusually considerably smaller than the
discount offered to category 1 countries.
CCR5 chemokine coreceptor 5
CF Clinton Foundation
CHAI Clinton Foundation HIV/AIDS
Initiative. Since 2002, the Clinton
Foundation HIV/AIDS Initiative (CHAI) has
assisted countries in implementing largescale, integrated care, treatment andprevention programs.
CHF Swiss franc
CIF “Cost Insurance and Freight”. A
commercial term (incoterm) meaning thatthe seller delivers once the goods pass
the ship's rail in the port of shipment. The
seller must pay the costs and freightnecessary to bring the goods to thenamed port of destination BUT the risk ofloss or damage to the goods, as well as
any additional costs due to eventsoccurring after the time of delivery, aretransferred from the seller to the buyer.
CIP “Carriage and Insurance paid to...”. A
commercial term (incoterm) meaning thatthe seller delivers the goods to the carrier
nominated by him, but the seller must in
addition pay the cost of carriage necessary
to bring the goods to the named
destination. This means that the buyer
bears all the risks and any additional costs
occurring after the goods have beendelivered. However, in CIP the seller also
has to procure insurance against thebuyer's risk of loss of or damage to thegoods during carriage. Consequently, theseller contracts for insurance and pays theinsurance premium.

CL compulsory licenced4T stavudine; nucleoside analogue
reverse transcriptase inhibitor
ddl didanosine; nucleoside analogue
reverse transcriptase inhibitor
DDU “Delivered duty unpaid”. A
commercial term (incoterm) meaning thatthe seller delivers the goods to the buyer,
not cleared for import, and not unloaded
from any arriving means of transport at
the named place of destination. The seller
has to bear the costs and risks involved inshipping the goods, other than, whereapplicable, any 'duty' (which includes the
responsibility for the risks of the carryingout of the customs formalities, and thepayment of formalities, customs duties,
taxes and other charges) for import in the
country of destination. Such 'duty' has tobe borne by the buyer as well as any
costs and risks caused by his failure toclear the goods for the import time.
DRV darunavir
EC enteric-coated
EFV or EFZ efavirenz; non-nucleosideanalogue reverse transcriptase inhibitor
EMEA European Agency for the Evaluationof Medicinal Products
EML Essential Medicines List. First
published by WHO in 1977, it serves to
identify a list of medicines, which provide
safe and effective treatment for infectious
and chronic diseases affecting the vast
majority of the world's population. The
15th Updated List was published in March
2007 and includes 14 antiretrovirals andfive fixed-dose combinations.
EU European Union

Médecins Sans Frontières • January 2010 • Untangling the Web of ARV Price Reductions • Please check utw.msfaccess.org • 97

EXW “Ex-works”. A commercial term(incoterm) meaning that the seller
delivers when he places the goods at thedisposal of the buyer at the seller's
premises or another named place (i.e.
works, factory, warehouse etc.) not
cleared for export and not loaded on any
collecting vehicle.
FDA United States Food and Drug
Administration
FDC fixed-dose combination - multiple
drugs combined in a single pill
FOB “Free on board”. A commercial(incoterm) term meaning that the seller
delivers when the goods pass the ship's
rail at the named port of shipment. Thismeans that the buyer has to bear all
costs and risks of loss or damage to thegoods from that point. The FOB term
requires the seller to clear the goods forexport.

HDI Human Development Index. A
summary composite index, compile by
UNDP, that measures a country's averageachievements in three basic aspects ofhuman development: longevity (or life
expectancy at birth), knowledge (or adultliteracy rate and enrolment in education),and a decent standard of living (grossdomestic product per capita).
HIV Human Immunodeficiency Virus
IDV indinavir; protease inhibitor
IRBM Institute for Research in Molecular
Biology

OAPI Organisation Africaine de la
Propriété Intellectuelle, African Intellectual
Property Organisation, whose member
states are Benin, Burkina Faso,
Cameroon, Central African Republic, Chad,
Congo, Côte d'Ivoire, Gabon, Guinea,
Guinea-Bissau, Equatorial Guinea, Mali,
Mauritania, Niger, Senegal, Togo.
PEPFAR President's Emergency Plan for
AIDS Relief, a United States programme
to fight HIV/AIDS in developing countries
PI Protease Inhibitor
PLWHA People Living With HIV/AIDS

LDCs Least-Developed Countries,
according to United Nations classification

PMTCT Prevention of Mother-to-Child
Transmission

LPV/r lopinavir/ritonavir; boosted
protease inhibitor

ppy per patient per year

MSD Merck Sharp & Dome (Merck & Co.,Inc.)

r low-dose ritonavir, used as a booster
R&D Research and Development
RAL raltegravir

FPV fosamprenavir

MSF Médecins Sans Frontières, Doctors
Without Borders

FTC emtricitabine; nucleoside analogue
reverse transcriptase inhibitor

MVC maraviroc

SQV saquinavir; protease inhibitor

NDRA National Drug Regulatory Authority

TAC Treatment Action Campaign

NFV nelfinavir; protease inhibitor

TB tuberculosis

NGO Non-Governmental Organisation

TDF tenofovir disoproxil fumarate;
nucleotide reverse transcriptase inhibitor

Generic drug According to WHO, apharmaceutical product usually intended
to be interchangeable with the originatorproduct, which is usually manufactured
without a license from the originatorcompany.
GPRM WHO Global Price Reporting
Mechanism is a database containing
prices paid by UNICEF, the International
Dispensary Association (IDA), Management
Sciences for Health (MSH)/Deliver, and the
Global Fund to Fight AIDS, Tuberculosis
and Malaria.
GSK GlaxoSmithKline

NIH National Institutes of Health
NNRTI Non-Nucleoside Reverse
Transcriptase Inhibitor
NRTI Nucleoside Analogue Reverse
Transcriptase Inhibitor
NtRTI Nucleotide Reverse Transcriptase
Inhibitor
NVP nevirapine; non-nucleoside analogue
reverse transcriptase inhibitor

RTV ritonavir; protease inhibitor

TPV tipranavir
TRIPS Trade-related Aspects ofIntellectual Property Rights
UN United Nations
UNAIDS United Nations Joint Cosponsored
Programme on HIV/AIDS, created in 1996,
to lead, strengthen and support an
expanded response to the HIV/AIDS98 • Médecins Sans Frontières • January 2010 • Untangling the Web of ARV Price Reductions • Please check utw.msfaccess.org

epidemic. The six original cosponsors are
UNICEF, UNDP, UNFPA, UNESCO, WHO andthe World Bank. UNDCP joined in April
1999.
UNDP United Nations Development
Programme
UNITAID is an international drug purchasefacility that was established in 2006 by
Brazil, Chile, France, Norway and theUnited Kingdom and now includes 27
countries to provide new sources offunding to fight HIV/AIDS, malaria andtuberculosis.
U.S. FDA United States Food and Drug
Administration
VL voluntary licence
WHO World Health Organization
WHO GPRM WHO Global Price Reporting
Mechanism
WTO World Trade Organization
ZDV zidovudine (also abbreviated to AZT);
nucleoside analogue reverse transcriptase
inhibitor

Acknowledgements:
Sheila Shettle for contributing to thebackground analysis.
Cover photos:
Brendan Bannon
Zethu Mlobeli
Design/artwork: Twenty 3 Crows Ltd+44 (0) 1848 200401

Médecins Sans Frontières • January 2010 • Untangling the Web of ARV Price Reductions • Please check utw.msfaccess.org • 99

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