Commission européenne, DG COMP MERGER REGISTRY, 1049 Bruxelles, BELGIQUE  
Europese Commissie, DG COMP MERGER REGISTRY, 1049 Brussel,   BELGIË  
 
Tel: +32 229 -91111. Fax: +32 229 -64301. E -mail: COMP -MERGER -REGISTRY@ec.europa.eu . 
 EUROPEAN COMMISSION  
 
 
 
 
 
Brussels, 04.12.2018  
C(2018)8437 final  
 
 
To the notifying party:  
 
Subject : Case M.9044 – CVC / RECORDATI  
Commission decision pursuant to Article 6(1)(b) of Council 
Regulation No  139/20041 and Article 57 of the Agreement on the 
European Economic Area2 
Dear Sir or Madam,  
(1) On 26 October 2018 , the European Commission received notification of a 
proposed concentration pursuant to Article 4 of the Merger Regulation by which 
CVC Capital Partners SIC AV-FIS S.A. ("CVC") acquires within the meaning of 
Article 3(1)(b) of the Merger Regulation sole control of Recordati SpA 
(”Recordati ” or the "Target" ) by way of purchase of shares ("the Transaction"). 
CVC and Recordati are referred to hereinafter as the P arties and CVC as the 
Notifying Party.3  
1. THE PARTIES  
(2) The primary business  activities  of the undertakings concerned are:  
 […]*  manages and provides advice to investment funds and platforms. The 
following portfolio companies are active in markets horizontally or vertically 
related to the Target's activities:  
                                                 
1  OJ L 24, 29.1.2004, p. 1 (the 'Merger Regulation'). With effect from 1 December 2009,  the Treaty on 
the Functioning of the European Union ('TFEU') has introduced certain changes, such as the 
replacement of 'Community' by 'Union' and 'common market' by 'internal market'. The terminology of 
the TFEU will be used throughout this decision.  
2  OJ L 1, 3.1.1994, p . 3 (the 'EEA Agreement').  
3  Publication in the Official Journal of the European Union No C 400 , 6.11.2018 , p. 15.  
* Should read: “the CVC network ” PUBLIC VERSION  In the published version of this decision, 
some information has been omitted pursuant 
to Article 17(2) of Council Regulation (EC) 
No 139/2004  concerning non -disclosure of 
business secrets and other confidential 
information. The omissions are shown thus 
[…]. Where possible the information omitted 
has been replaced by ranges of figures or a 
general description.  
 
2 o Alvogen is a global pharmaceutical company whose product portfolio 
consists of a broad range of generic, branded, and biosimilar products  for 
use in oncology, cardiology, respiratory, neurology and gastroenterology 
treatments. Alvogen currently has commer cial operations in 35 countries 
across North America, Central and Eastern Europe and Asia Pacific.  
o DOC Generici  is a generic pharmaceutical company in Italy focused on 
developing and manufacturing cardiovascular, gastroenterology & 
metabolic and neurology products.  
o Elsan is a French private healthcare business, operating more than 35 
health clinics primarily focused on medicine, surgery and obstetrics.  
o Metropolitan is a Greek private hospital.  
 Recordati develops and markets branded and generic drugs for the  treatment of 
hypertension and other cardiovascular disorders, disorders of the lower urinary 
tract as well as drugs for treatment of rare diseases such as metabolic deficiencies 
of a genetic nature.  
2. THE OPERAT ION 
(3) On 29 June 2018, the Parties entered into a share purchase agreement according 
to which CVC acquires through special purpose vehicles a controlling 
shareholding of approximately 51.8% in the Target. None of the other 
shareholders besides CVC will have any veto right over the strategic decisions of  
the Target, including decisions regarding the Target's annual budget, business 
plan or appointment of senior management.  
(4) Therefore, the Transaction involves the acquisition of sole control of Recordati by 
CVC within the meaning of Article 3(1)(b) of the Merger Regulation.  
3. EU DIMENSION  
(5) The undertakings concerned have a combined aggregate world -wide turnover of 
more than EUR 5 000 million4 (CVC: EUR […] million; Recordati: EUR […] 
million). Each of them has an EU -wide turnover in excess of EUR 250 million 
(CVC: EUR […] million; Recordati: EUR […] million). The Parties do not 
achieve more than two -thirds of their Community -wide turnover within one and 
the same Member State.  
(6) The noti fied operation therefore  has an EU dimension by virtue of Article 1(2) of 
the Merger Regulation.  
                                                 
4  Turnover calculated in accordance with Article 5(1) of the Merger Regulation and the Commission 
Consolid ated Jurisdictional Notice (OJ C95, 16.4.2008, p. 1).  
 
3 4. COMPETITIVE  ASSESSMENT   
4.1  Market definition s  
(7) The Transaction gives rise to horizontal overlaps in relation to several  finished 
dose pharmaceuticals  ("FDPs") marketed by both Parties .5 […]*  also develops 
pipeline products  that overlap with FDPs marketed by  […]** . Finally, t he 
Transaction also gives rise to potential vertical links between Recordati’s 
activities on the market s for FDPs  (upstream markets) and the provision of 
hospital services by CVC  […]***  portfolio companies (downstream markets).  
 4.1.1  Finished dose pharmaceutical products ("FDP")  
Product market definition  
(8) In previous decisions6 concerning the pharmaceutical sector,  the Commission has 
noted that pharmaceutical products may be classified into therapeutic classes by 
reference to the Anatomical Therapeutic Classification (ATC)7. This 
classification has the advantage of being developed and maintained for 
commercial use a nd providing ready access to statistics. It is based on finished 
dose pharmaceutical  products and their approved indications in the various 
countries, which may in many cases vary from one country to another.  
(9) In the EphMRA ATC system, medicines are classif ied into groups at four 
different levels. In the first and broadest level (ATC1), medicinal products are 
divided into the 16 main anatomical groups. The second level (ATC2) represents 
either a pharmacological or therapeutic group. The third level (ATC3) fu rther 
groups medicinal products by their specific therapeutic indications, i.e. their 
intended use. The ATC4 level is the most detailed one (not available for all 
ATC3) and refers for instance to the mode of action (e.g. distinction of some 
ATC3 classes in to topical and systemic depending on their way of action) or any 
other subdivision of the group. Finally, the level of the chemical substance is the 
so-called molecule level  (ATC5) . 
(10) In previous decisions, the Commission has referred to the ATC3 level as the 
starting point for defining the relevant product market. The Commission found 
however that the ATC3 level classification did in many cases  not provide the 
appropriate market defini tion within the meaning of the Commission Notice on 
Definition of the Relevant Market8. Thus, where appropriate and based on the 
                                                 
5  Finished dose pharmaceuticals are essentially pharmaceutical products in the form in which they are 
marketed for use, typically involving a mixture of active drug components and nondrug components 
(excipients), along with other non -reusable material that may not be considered either ingredient or 
packaging (such as a capsule shell, for example).  
6  M.7746 – Teva/Allergan Generics ; M.7559 – Pfizer/Hospira ; M.7379 – Mylan/Abbott EPD -DM; 
M.6613 – Watson/Actavis.  
7  The ATC classification devised by the European Pharmaceutical Marketing Research Association 
("EphMRA") and maintained by EphMRA and Intercontinental Medical Statistics ("IMS").  
8  OJ C 372, 9.12.1997, p. 5.  
* Should read: “ CVC Funds por tfolio companies”  
** Should read: “ the Target”  
*** Should read: “Funds”  
 
4 factual evidence collected during the market investigation, the Commission 
defined the relevant product market at the level of the molecule9.  
(11) As regards genericised products,  for which the originator drug lost market 
exclusivity and competes with generic drugs , the Commission has taken the view 
that the molecule level is the most plausible starting point for the product market 
definition, given that generic pharmaceutical companies typically produce copies 
of originator drugs10 and thus it can be considered that a generic molecule is the 
closest substitute to the originator medicinal product based on the same molecule 
or API11. As s et out in the Commission's Horizontal Merger Guidelines12, the 
higher the degree of substitutability between the merging firms' products, the 
more likely it is that the merging firms will raise prices significantly13. 
(12) As regards a  potential distinction betwe en generic and originator medicines , in 
previous decisions14, the Commission set out that where the market is genericised, 
originator drugs and generics could be considered to be close substitutes for a 
given indication and a product market may be defined a s including both the 
generic and the originator medicine.  
(13) In the present case , in line with the previous practice, the Commission takes the 
molecule level as the most plausible starting point for the product market 
definition.  
(14) Regarding a potential disti nction between originator and generic products , during 
the market investigation in the present case the respondents indicated that brand 
recognition and price differentiate originator products from the generic products  
based on the same molecule15. In this regard, brand loyalty to the originator 
medicine may play a role in limiting  the number of  customer s switching away 
from the originator drug  in certain instances, and thus limiting the competition 
that takes place between originator and generic providers16. However, such 
dynamics are typical of differentiated products within a product market where 
brand recognition and marketing can influence customers' decision between 
substitutable products. Therefore, for the purposes of the competitive assessment 
                                                 
9  See for example M.7559 – Pfizer/Hospira  and M.5253 – Sanofi -Aventis/Zentiva . 
10  Generics are in general less expensive versions of the originator drugs. In regulatory approval 
proce dures, a generic drug manufacturer has to demonstrate that the generic version of the originator 
drug has identical composition in active substances, same strength and pharmaceutical form; and is 
biologically equivalent to the originator drug. See for exam ple M.5253 – Sanofi -Aventis/Zentiva  and 
M.5295 – Teva/Barr.  Note however that there may still be small differences, such as in inactive 
ingredients, which may lead in certain, probably relatively uncommon cases, to the drugs being non -
equivalent from a med ical standpoint.  
11  See M. 7746 - Teva/Allergan Generics ; M.7559 – Pfizer Hospira ; M.7379 – Mylan/Abbott EPD -DM; 
M.6613 – Watson/Actavis.    
12  Guidelines on the assessment of horizontal mergers under the Council Regulation on the control of 
concentrations  between undertakings (“Horizontal Merger Guidelines”), OJ C 31, 5.2.2004, p. 5, para 
28. 
13  See M.5253 – Sanofi -Aventis/Zentiva.  
14  See M. 4418 - Nycomed Group/Altana Pharma  and M.3751 - Novartis/Hexal.  
15  See Section 4.2.1.2 below.  
16  See for example M.5865 - TEVA/ RATIOPHARM.  
 
5 of the Transaction, the Commission considers that in relation to the overlapping 
molecules the product market includes both generic and originator versions.17  
(15) In addition, medicines are differentiated not only by their active ingredient(s), but 
also, as recognise d by the European regulatory framework for medicines for 
human use18, by their dosage, pharmaceutical form and route of administration, 
which may limit their substitutability. The Commission looked in the past at the 
pharmaceutical form or "galenic" form wi th reference to the first letter of the 
typology of form codes ("New Form Code 1", or "NFC1"), for the purposes of 
defining the relevant product market.  
(16) The market investigation in the present case has shown, for some of the molecules  
considered, that dif ferent routes of administration and the pharmaceutical form s 
of a medicine may have limited substitutability19. In any event, the question of 
whether the relevant markets should be further subdivided according to the 
galenic form can be left open for the pu rpose of this decision as the competitive 
assessment of individual markets would not change irrespective of galenic form 
concerned. 20  
Geographic market definition  
(17) As regards the geographic market definition, the Notifying Party has submitted an 
overview of the overlapping molecules on a country -by-country basis. The 
Commission has consistently held that the market for finished pharmaceutical 
products is national in scope21. This conclusion has been reached because of (i) 
varying regulatory controls for pha rmaceutical products; (ii) perceived differences 
in price setting and purchasing patterns/reimbursement by Member States; (iii) 
differences in national clinical guidelines , medical views and patient preferences; 
(iv) differences in brand, pack size and dis tribution system s; and (v) because 
competition between pharmaceutical companies generally takes place at national 
level22.  
(18) There is no reason to depart from the previous practice in the present case.  
                                                 
17  In any event, in the present case, a potential distinction between generic and originator medicines 
would significantly reduce the overlaps between the activities of the Parties since, in most cases, the 
overla ps result from the combination of the Target's originator product and CVC's generic product. 
Therefore, should the market be defined at originator or generic level, the Parties' activities would not 
overlap (subject to one exception, i.e. aciclovir in Ital y – see Section 4.2.1.2).  
18  The European regulatory framework for human medicines sets standards to ensure a high level of 
public health protection and the quality, safety and efficacy of authorised medicines and to promote 
the functioning of the internal  market. It is based on the principle that a medicinal product requires a 
marketing authorisation by the competent authorities before being placed on the market.  
19  See replies to questions 11, 38, 65, 74 of questionnaire Q2 to customers in Italy and quest ions 6, 22, 42 
of questionnaire Q1 to competitors.  
20  See below recital 31 . 
21  See for example M. 7746 - Teva/Allergan Generics  and M.7559 – Pfizer/Hospira.  
22  See for example M.6705 Procter&Gamble/Teva Pharmaceuticals OTC II  and M.6280 P&G/Teva 
OTC Business.  
 
6 4.1.2  Pipeline generic pharmaceuticals  
Product market definition  
(19) Following the same approach as for FDPs  and in line with past decisions,23 the 
Commission takes the molecule level as the most plausible relevant market for 
pipeline generic pharmaceuticals, considering that a pipeline generic molecule is 
typical ly the closest substitute to the other generic medicinal product based on the 
same molecule. There is no reason to depart from the previous practice in the 
present case.  
Geographic market definition  
(20) For pipeline products, the Commission previously considered that the geographic 
scope of the relevant market is at least EEA -wide.24 There is no reason to depart 
from the previous practice in the present case.  
4.1.3  Hospital  services  
Product market definit ion 
(21) The Commission has analysed the market for the provision of hospital services in 
a number of decisions, distinguishing between inpatient (acute) hospital 
procedures conducted in hospitals and outpatient (ambulatory) procedures 
conducted in hospitals.25 The Commission has also examined whether a 
distinction between different specialist medical departments should be made26, 
ultimately leaving open the exact definition . Furthermore, the Commission has 
considered whether a distinction between private (or ind ependent) hospitals and 
public hospitals could be appropriate although the exact delineation largely 
depended on the specificities of the case and the national market in question.27 
For example, a separate market for private acute general hospitals was defi ned for 
the UK because on the UK market the demand for such services was different 
from the demand for public acute general hospitals.28  
Geographic market definition  
(22) As to the geographical definition, in prior decisions the Commission indicated 
that the ma rket for private hospitals was no t broader than national in scope.29 
Ultimately, it was left open whether the market is national, regional or local in 
scope.30 
                                                 
23  See M.7645 – Mylan / Perrigo ; M.7559 – Pfizer / Hospira ; M.7379 - Mylan/ Abbott EPD -DM. 
24  See M.7645 – Mylan / Perrigo ; M.7559 – Pfizer / Hospira ; M.7379 - Mylan/ Abbott EPD -DM. 
25  M.8146 – Carlyle/Schön Family/Schön Klinik.  
26  M.8146 – Carlyle/Schön Family/Schön Klinik.  
27  M.4010 – Fresenius/Helios.  
28  M.4367 – APW/ Nordic Capital/ APSA/ Capio.  
29  M. 4229 APHL/L&R/Netcare General Healthcare Group ; M.4788 Rozier/BHS.  
30  M.4010 – Fresenius/Helios.  






 
13 (36) Second, post-Transaction, the Parties will continue to face competition from 
numerous players: six other sellers of aciclovir have shares of supply of over 5% 
in value in Italy and two of them (Stada and Mylan) have value shares equal to or 
higher than the combined Parties.38  
(37) Third , at molecule level, the Parties ' products do not seem to be close substitutes . 
There are three different galenic forms for J5B aciclovir: class A (oral solid 
ordinary), class D (oral liquid ordin ary) and class F (parenteral ordinary).  The 
Parties' activities overlap with none of them in Italy. They supply different 
galenic forms , with modes of administration that are entirely different (oral vs. 
injectable),  under different channels: DOC Generici  (CVC) sells orally -
administered products (NFC1 A and D classes) to wholesalers and pharmacies, 
while the Target sells injectable products (NFC1 F class) to hospitals .  
(38) As regards pricing and reimbursement of medicinal products in Italy, as indicated  
by th e Notifying Party, the Italian National Healthcare System reimburses the 
lowest price  among the prices of off -patent medicinal products with 
interchangeable active ingredients, the same pharmaceutical form, same method 
of administration, same number of uni ts and same unit dosage. Any difference 
from this reference price is paid by patients if they refuse  an interchangeable 
generic alternative and/or their doctor prescribes a pharmaceutical product with a 
price higher than the reference price and specificall y provides that this product 
cannot be substituted with other products. Thus, the reimbursement system 
provides incentives to the generic suppliers to price their products similarly, 
unless they are successful in differentiating them  in terms of package s ize, 
dosage, etc.39 
(39) Based on the above considerations, in particular the fact that the Parties are not 
close competitors and that the overlap is moderate , the Commission concludes 
that the Transaction does not raise serious doubts as to its compatibility with the 
internal market in relation to the supply of J5B ac iclovir in Italy  irrespective of 
whether the market is subdivided by galenic form . 
Domperidone – Italy  
(40) Domperidone is a blocker of dopamine receptors. It is  used for the treatment  of 
nausea and vomiting . 
(41) The overlap on the domperidone market in Italy is between Recordati’s originator 
product (Peridon) and DOC Generici's generic product ( Domperidone  DOC).   
(42) The Notifying  Party submits that despite the high combined market shares of the 
Parties for domperidone, th e increment arising from DOC Generici is minimal 
and the Transaction does not materially change the competitive landscape . 
                                                 
38  See Form CO, Annex 17.  
39  See Form CO, Annex 20.  
 
14 (43) The Commission considers that concerning the market for dom peridone in Italy  
and its potential sub -segments40, the Transaction does not raise serious doubts as 
to it compatibility with the internal market for the following reasons.  
(44) First, the overlap is limited. The Parties' high combined market share in the 
Domperidone market in Italy primarily reflects the strong market position of 
Recordati's originator product . DOC Generici's sales are very limited ( […] k€ in 
2017). As a result, the increment brought by the Transaction is modest ( [0-
5]%both in value and vo lume ). 
(45) Second, t he domperidone market in Italy is largely genericised and there are more 
than 15 companies active on the market  (both at molecule and NFC1 A levels) , of 
which 4 have market share s larger than the increment brought by DOC Generici  
(namely Jo hnson & Johnson, Stada, Teva, and Mylan) . Some offer originator  
products (namely Johnson & Johnson's Motilium), but most supply generic 
versions. Both customers and competitors consider that the market is competitive  
due to the large number of alternative suppliers .41 In fact, most customers 
multisource  and have between 4 and more than  10 different suppliers . For the vast 
majority  of them , switching suppliers is relatively easy.42  
(46) Third , the market investigation indicated that the Parties are not close 
competitors, as DOC Generici's generic domperidone competes more close ly with 
multiple other generics of the same medicine  than with Recordati's originator 
domperidone. In particular; price and brand recognition are considere d as key 
parameters of competition by most respondents  and Recordati 's originator product 
is differentiated from generics due to its established brand and a certain degree of 
customer loyalty.43 Conversely, no specific competitive advantage was identified 
for DOC Generici’s generic domperidone, which is described as being 
comparable to the other generic products.44 According to a generic competitor , 
"the brand market and generic one have market dynamic completely different ".45 
Also, price competition appear s greater between generics than it is between 
generics and Recordati's originator domperidone.  According to the national 
pricing and reimbursement  rules , explained above, patients are reimbursed  only 
up to  the amount of the cheapest generic version. If they choose to buy the more 
expensive originator s, they pay the price difference. Due to this feature, price 
competition on the domperidone market takes place more intensely between the 
different generic supplies , which are numerous and will continue to exert 
competitive pressure on the merged entity .  
(47) Fourth , there are three different galenic forms for A3F domperidone: class A (oral 
solid ordinary), class D (oral liquid ordinary ), and class H (rectal systemic). The 
market investigation suggests that , at molecule level , due to the difference in 
                                                 
40  On this market, the Parties' activities overlap both at molecule and galenic form levels.  
41  Replies to question 12 of questionnaire Q2 to customers in Italy a nd question 7 of questionnaire Q1 to 
competitors.  
42  Replies to questions 8, 18, and 20 of questionnaire Q2 to customers in Italy.  
43  Replies to questions 13 to 16 of questionnaire Q2 to customers in Italy and questions 8 to 11 of 
questionnaire Q1 to compe titors.  
44  Replies to question 16 of questionnaire Q2 to customers in Italy and question 11 of questionnaire Q1 
to competitors.  
45  See Aristo Pharma's non -confidential reply to question 13 of questionnaire Q1 to competitors.  
 
15 galenic form, the Parties  are not close competitors : (i) t he replies of the market 
participants show that substitutability between the three galenic forms may be 
somewhat limited46 and (ii) DOC Generici's products fa ll within the NFC1 A 
class and the Target's products fall within classes A, D and H ; in other words, the 
Parties  overlap only with respect to one galenic form.  
(48) Finally, the Commission notes that all informative respondents consider that  the 
impact of the Transaction will be " neutral " on the domperidone market in Italy. A 
large number of customers indicated that there will remain sufficient alternative 
sources of supply post -Transaction  regardless of the galenic form . The customers 
that took the opposite vi ew mostly complained about the lack of alternatives to 
Recordati in relation to galenic forms for which the Parties' activities do not 
overlap .47 
(49) Based o n the above  considerations , in particular the fact that the Parties are not 
close competitors  and that the overlap is limited , the Commission concludes  that 
the Transaction does not raise serious doubts as to its compatibility with the 
internal market in relation to the supply of domperidone in Italy  irrespective of 
whether the market is subdivided by galen ic form . 
Ketorolac - Italy 
(50) Ketorolac is  a pyrrolizine carboxylic acid derivative. It  is used as an  analgesic.  
(51) The overlap on the ketorolac  market in Italy is between Recordati’s originator 
products ( Toradol ) and DOC Generici's generic product ( Ketorolac DOC ). 
(52) The Notifying Party submits that the increment arising from DOC Generici is 
minimal and the Transaction does not materially change the competitive 
landscape.  
(53) The Commission considers that concerning the market for ketorolac  in Italy  and 
its potential sub -segments48, the Transaction does not raise serious doubts as to it 
compatibility with the internal market for the following reasons.  
(54) First, the overlap is limited. S imilarly to domperidone,  the Parties' high combined 
market share on t he ketorolac market in Italy primarily reflects the strong market 
position of Recordati's originator product . DOC Generici 's sales of ketorolac are 
very limited ( […] k€ in 2017). As a result, the increment of the Transaction is 
modest [0-5]% in value and [0-5]% in volume .  
(55) Second , the ketorolac market is largely genericised , with a large number of 
competitors. Post -Transaction, there would remain no less than 10 other suppliers , 
including several players with market share larger than the increment brought by 
                                                 
46  Replies to question 11 of questionnaire Q2 to customers in Italy and question 6 of questionnaire Q1 to 
competitors.  
47  Replies to questions 21 -22 of questionnaire Q2 to customers in Italy and question 13 of questionnaire 
Q1 to competitors.  
48  On this market, the Parties' activities  overlap both at molecule and galenic form levels.  
 
16 DOC Generici  (such as Mylan  and So.Se.Pharma)  and one alternative originator 
product (namely Atnahs Pharma's Lixidol) . The Commission also notes that, over 
the past three years, Mylan's market share has sig nificantly increased ( +[5-10]%  
in value and +[5-10]%  in volume in 2017 compared to 2015), while the Parties' 
combined share has decreased ( -[0-5]%in value and -[0-5]% in volume in 2017 
compared to 2015).  In fact, most market participants consider that the ketorolac 
market is rather competitive.49 The market investigation also shows that most 
customers multisource, with up to 10 different suppliers, and a large number of 
them indicated that switching is relatively easy.50 
(56) Third, the market investigation indica ted that the Parties are not close 
competitors, as DOC Generici's generic ketorolac competes more close ly with 
multiple other generics of the same medicine than with Recordati's originator 
product . Price and brand recognitions are among the key parameters of 
competition for both customers and competitors. Recordati's originator product is 
differentiated from generics due to its established brand and a certain degree of 
customer loyalty. Conversely, no spec ific competitive advantage was identified 
for DOC Generici’s products.51 Also, competition appears greater between 
generics than it is between generics and Recordati's originator ketorolac due the 
national pricing and reimbursement rules, according to which  patients are 
reimbursed only up to the amount of the cheapest generic version. If they cho ose 
to buy the more expensive originator, they pay the price difference. Due to this 
feature, price competition on the ketorolac market takes place more intensely 
between the different generic supplies,52 which are numerous and will continue to 
exert competitive pressure on the merged entity.  
(57) Fourth , there are three different galenic forms for ketorolac: class A (oral solid 
ordinary), class D (oral liquid ordinary ) and class F (parenteral ordinary). 
Recordati offers the three galenic forms , contrary to DOC Generici , which offers 
only classes D and F . This product portfolio difference further limits the degree of 
closeness of competition between the Parties  at molecule level .53  
(58) Finally, all informative respondents (both customers and competitors) consider 
that the impact of the Transaction will be " neutral " on the ketorolac market in 
Italy regardless of the galenic form .54 
(59) Based o n the above  considerations , in particular the fact that the Parties are not 
close competitors  and that the overlap is limited,  the Commission considers that 
the Transaction does not raise serious doubts as to its compatibility with the 
internal market in relation to  the supply of  ketorolac in Italy  irrespective of 
whether the market is subdivided by galenic form . 
                                                 
49  Replies to question 28 of questionnaire Q2 to customers in Italy.  
50  Replies to questions 24, 34, and 36 of questionnaire Q2 to customers in Italy.  
51  Replies to questions 28 to 32 of questionnaire Q2 t o customers in Italy and questions 16 to 20 of 
questionnaire Q1 to competitors.  
52  See Form CO, Annex 20.  
53  Replies to question 27 of questionnaire Q2 to customers in Italy and question 15 of questionnaire Q1 
to competitors.  
54  Replies to question 38 of questionnaire Q2 to customers in Italy and question 22 of questionnaire Q1 
to competitors.  
 
17 Lercanidipine – Italy  
(60) Lercanidipine is  an antihypertensive drug. It is used  for the treatment of mild to 
moderate hypertension.  
(61) The overlap on the lercanid ipine market in Italy is between Recordati’s originator 
products (Lercadip and Zanedip) and DOC Generici's generic product s 
(Lercanidipina DOC).  
(62) The Notifying Party claims that lercanidipine is demonstrably substitutable with 
several  other calcium channel blockers (CCBs).  In particular, it submitted that 
[…]. Doctors in Italy contacted in the context of the market investigation 
explained that both lercanidipine and amlodipine belong to dihydropiridine CCBs. 
Dihydropiridine CCBs are among the most effective antihypertensive  agents. 
Amlodipine share s similar effects with lercanidipine. However, considering that 
neither the Notifying Party nor the market investigation produced conclusive 
evidence that the CCBs were not only therapeutic substitutes, but were actual, 
economic substitutes, the Commission cannot exclude that the product market is 
limited to lercanidipine. Therefore, the subsequent assessment takes into account 
the candidate market for medicines with lercanidipine as the active ingredient.  
(63) The Notifying Party also submits that despite the relatively high combined market 
shares of the Parties for lercanidipine  in Italy , the Transaction does not raise 
competition concerns on the ground s that (i) the Parties are not close competitors 
(originator vs. generic), (ii) the Target's market share has steadily declined since 
its loss of exclusivity  in 2010 , (iii) the Parties face a large number of competitors, 
and (iv) the Italian price regulation is strict favouring price competition to the 
benefit of generic competitors . 
(64) The Commission considers that c oncerning the market for lercanidipine in Italy55, 
the Transaction does not raise serious doubts as to it compatibility with the 
internal market for the following reasons.  
(65) First, the overlap is moderate, with a [5-10]%  increment in value ([10-20]%  in 
volume ) brought by DOC Generici . The Parties' high combined market share on 
the lercanid ipine market in Italy primarily reflects the strong market position of 
Recordati's originator product . 
(66) Second, the market is largely genericised and there are more than 10 companies 
active on the market, including Mylan, w hich has a higher market share than 
DOC Generici ( [5-10]%  in value and [10-20]%  in volume in 2017), as well as 
many other credible players, such as Polifarma, Novartis, Stada, and Teva . Post-
Transaction, t he new entity will face both competing originator products 
(Polifarma 's Cardiovasc) and generic products . In fact, most market participants 
consider that the lercanidipine market is competitive  due to the larger number of 
suppliers .56 For instance, a compet itor indicated that the market is “ very 
competitive because of takeover of generics  […] the generics’ market shares 
                                                 
55  The segmentation based on the galenic forms is not relevant on lercanidipine market where there is 
only one galenic form.  
56  Replies to question 27 of questionnai re Q2 to customers in Italy and question 15 of questionnaire Q1 
to competitors.  
 
18 increase every year ”57, which is corroborated by the Parties' market share 
estimates. The market investigation also showed that most customers (including 
both wholesalers and pharmacies) multisource and have between 4 and more than  
10 different suppliers. For a large number of them , switching is relatively easy.58 
(67) Third, d espite relatively high market shares of Recordati for it s originator 
lercanidipine, the Parties are not close competitors, as DOC Generici's generic 
lercanidipine competes more closely with multiple other generics of the same 
medicine . 
(68) In the first place, t he price, brand recognition and reliability of supply a re 
considered as key parameters of competition by both customers and competitors. 
Recordati 's originator product is differentiated from generics due to its established 
brand and a certain degree of customer loyalty . No specific competitive advantage 
was id entified for D OC Generici’s generic lercanidipine .59 For instance, a 
competitor stated that: " Lercadip and Zanedip [i.e. Recordati's brand products] 
are well known brands prescribed by physicians since years. Lercarnidipine DOC 
(as for the other generic products) is not differentiated but has a lower price ".60  
This has allowed Recordati to retain a significant market share despite the 
presence of several generics at significantly lower prices.   
(69) In the second place , price competition is more intense betwee n generics than it is 
between generics and Recordati's originator lercanidipine. According to the 
national pricing and reimbursement rules, explained in recital 38, patients are 
reimbursed only up to the amount of the cheapest generic version and they pay 
the price difference if they cho ose to buy the more expensive competing product . 
Due to this feature,  price competition on the lercanidipine market takes place 
more intensely between the different generic  […]* , which are numerous and will 
continue to exert  competitive pressure on the merged entity. Accordingly, the 
evolution of prices, volume and value shares does not suggest intense competition 
between originator and generic products after the initial period of genericisation 
around the generic entry in 20 10, when a significant part of demand for 
lercanidipine shifted to generic products. 61 
(70) Finally, the Commission notes that all informative respondents consider that  the 
impact of the Transaction will be " neutral " on the lercanid ipine market in Italy. 
Moreover, 80% of the customers indicated that there will remain sufficient 
alternative sources of supply post -Transaction.62 
(71) Based o n the above  considerations , in particular the fact that the Parties are not 
close competitors  and that the overlap is moderate , the Commission concludes  
                                                 
57  See Polifarma's non -confidential reply to question 25 of questionnaire Q1 to competitors.  
58  Replies to question 27 of questionnaire Q2 to customers in Italy and question 15  of questionnaire Q1 
to competitors.  
59  Replies to questions 44 to 47 of questionnaire Q2 to customers in Italy and questions 26 to 29 of 
questionnaire Q1 to competitors.  
60  Sandoz (Novartis)'s non -confidential reply to question 28 of questionnaire Q1 to competitors.  
61  See notably Form CO, Annex 20.  
62  Replies to questions 52 and 53 of questionnaire Q2 to customers in Italy and question 31 of 
questionnaire Q1 to competitors.  
* Should read: “suppliers”  
 
19 that the Transaction does not raise serious doubts as to its compatibility with the 
internal market in relation to  the supply of  lercanidipine  in Italy.  
Fixed combination lercanidipine and enalapril  - Italy 
(72) The molecular combination lercanidipine and enalapril (C9B – ACE inhibitors, 
combinations) is a combination hypertension therapy of lercanidipine (a calcium 
channel blocker) and enalapril (an ACE inhibitor).  
(73) The overlap on the fixed combination lercanidi pine and enalapril market in Italy 
is between Recordati ’s originator product (Zanipril) and DOC Generici's generic 
product (Enalapr/Lercan Doc).  
(74) The Commission considers that concerning the market for lercanidipine and 
enalapril in Italy63, the Transaction does not raise serious doubts as to it s 
compatibility with the internal market for the following reasons.  
(75) First, DOC Generici only began selling its generic version of this Recordati -
originated product in 201864 and the increment brought by the Transaction is very 
limited (below 0.5%  in both value and volume ). The Parties' high combined 
market share on the lercanid ipine market in Italy primarily reflects the strong 
market position of Recordati's originator product . 
(76) Second, there are five other competitors of fering th is molecule combination. Two 
companies market originator products (with market shares of respectively [10-
20]% and [10-20]% in value in 2017) and three sell a generic version (one with a 
market share of [5-10]%  in value in 2017).65 
(77) Third, Recordati 's and DOC Generici's respective originator products and generic 
products are not close competitors . This is notably illustrated by the significant 
price differentials between Recordati's originator product, on the one hand, and 
the generics products, on t he other hand (+[50 -60%]) .66 
(78) Based o n the above, the Commission concludes that the Transaction does not 
raise serious doubts as to its compatibility with the internal market in relation to 
the supply of lercanidipine and enalapril in Italy.  
Rupatadine - Italy 
(79) Rupa tadine  is a dual histamine H1 receptor. It is used as an anti-allergenic.  
                                                 
63  The segmentation based on the galenic forms is not relevant on this market where there is only one 
galenic form.  
64  See Form CO, footnote 31.  
65  See the Notifying Party's reply to RFI 4, question 2.  
66  See the Notifying Party's reply to RFI 4, question 2.  
 
20 (80) The overlap on the rupatadine market in Italy is between Recordati’s originator 
products  (Rupafin ) and DOC Generici's generic product ( Rupatadina DOC ). 
(81) The Notifying Party submits that the increment arising from DOC Generici is 
minimal and the Transaction does not materially change the competitive 
landscape.  
(82) The Commission considers that concerning the market for rupatadine in Italy  and 
its potential sub -segments67, the Transaction does not raise serious doubts as to it 
compatibility with the internal market for the following reasons.  
(83) First, the overlap is limited. The increment brought by DOC Generici on the 
rupatadine market in 2017 is [0-5]% in value and [0-5]% in volume. The Parties' 
substantial combined market share ([40-50]%)  primarily reflects the market 
position of Recordati's originator product.  
(84) Second, the Parties face several credible competitors, including t he market leader , 
Mylan, which offer s on the rupatadine market both originator products (Pafinur) 
and generic product s (Rupatina Myl PH) . Mylan's market share of [50-60]%  in 
value and [50-60]%  in volume in 2017 is higher than the combined share of the 
Parties. Moreover, following t he recent expiry of patent protection and market 
exclusivity in 2017, besides DOC Generici, two other credible generic 
competitors entered the Italian rupatadine market, namely Teva and Stada.  In fact, 
most customers multisource and have between 4 and 5 different suppliers. For the 
vast majority of them, switching suppliers is relatively easy.68  
(85) Third, the market investigation indicated that the Parties are not close 
competitors, as DOC Generici's generic rupatadine competes more close ly with 
the three ot her generics of the same medicine than with Recordati's originator 
rupatadine.  Price and brand recognitions are considered as key parameters of 
competition by both customers and competitors  and Recordati's originator product 
is differentiated from generic s due to its established brand and a certain degree of 
customer loyalty. Conversely, no specific competitive advantage was identified 
for DOC Generici’s generic rupatadine.69 Also, price competition appears greater 
between generics than it is between generi cs and Recordati's originator 
rupatadine. As previously explained, under the national regulation, patients are 
reimbursed only up to the amount of the cheapest generic version. If they ch oose 
to buy the more expensive originators, they pay the price differ ence. Due to this 
feature, price competition on the rupatadine market takes place more intensely 
between the different generic suppliers, which will continue to exert competitive 
pressure on the merged entity.70 
(86) Fourth, the market investigation suggests tha t, due to the difference in galenic 
form, the Parties  are not close competitors at molecule level . There are two 
different galenic forms for rupatadine, i.e. class A (oral solid ordinary) and class 
D (oral liquid ordinary), and the Parties overlap only with respect to one galenic 
                                                 
67  On this market, the Parties' activities overlap both at molecule and galenic form levels.  
68  Replies to questions 71, 81, and 83 of questionnaire Q2 to customers in Italy.  
69  Replies to questions 76 to 79 of questionnaire Q2 to customers in Italy and questions 44 to 47 of 
questionnaire Q1 to competitors . 
70  See Form CO, Annex 20.  
 
21 form:  DOC Generici's products fall within the NFC1 A class and the Target's 
products fall within classes A and D. The replies of the market participants show 
that substitutability between the […]*  galenic fo rms may be somewhat limited.71 
(87) Finally, the Commission notes that all informativ e respondents consider that  the 
impact of the Transaction will be " neutral " on the rupatadine market in Italy  
regardless of the galenic form . In particular, half of the customer s indicated that 
there will remain sufficient alternative sources of supply post -Transaction  
regardless of the galenic form . The customers that took the opposite view mostly 
complained about the lack of alternatives to Recordati in relation to galenic form s 
for which the Parties' activities do not overlap ( NFC1 D class) .72  
(88) Based o n the above  considerations , in particular the fact that the overlap is 
marginal and that the Parties are not close competitors , the Commission considers 
that the Transaction does not raise serious doubts as to its compatibility with the 
internal market in relation to  the supply of  rupatadine in Italy  irrespective of 
whether the market is subdivided by galenic form . 
Metoprolol – Italy 
(89) […]**  is a cardioselective β1 -adrenergic blockin g agent. It is used  for the 
treatment of acute myocardial infarction, heart failure, angina pectoris and mild to 
moderate hypertension.  
(90) The overlap on the metoprolol market in Italy is between Recordati’s originator 
product (Seloken) and DOC Generici's generic product (Metoprololo Doc).  
Seloken is an originator product that Recordati sources from AstraZeneca. 
Seloken was first put on the market in Italy in 1978, but Recordati acquired the 
rights to sell it in 2017.73 DOC Gen erici’s metoprolol product is a generic product 
and was launched in 2003.  
(91) The Notifying Party submits that the combined market share in value and in 
volume is not particularly high and barely surpasses the Group 1 threshold  of 
35%. The Notifying Party also  notes that the merged entity will continue  to face 
strong competition  from numerous  generic  distributors.  
(92) The Commission considers that concerning the market for metoprolol in Italy  and 
its potential sub -segments74, the Transaction does not raise serious doubts as to it s 
compatibility with the internal market for the following reasons.  
                                                 
71  Replies to question 74 of questionnaire Q2 to customers in Italy and question 42 of questionnaire Q1 
to competitors.  
72  Replies to questions 84 and 85 of questionnaire Q2 to customers in Italy and question 49 of 
questionnaire Q1 to competitors.  
73  Recordati acquired the rights to sell AstraZeneca's metoprolol in Italy but also in other of EEA 
countries, including Iceland and Romania, where the Transaction gives rise to affected markets.  
74  On this market, the Parties' activities overlap both at molecule and galenic form levels.  
* Should read: “two”  
** Should read: “Metoprolol”  
 
22 (93) First, the overlap in the Italian metoprolol market is moderate . Recordati is the 
second largest player , with a market share of [30-40]% by value and [20-30]%  by 
volume (in 2017), while DOC Generici is one of the several generic companies , 
with a moderate market share of [5-10]%  and [10-20]% by v alue and in volume 
respectively . Post-Transaction, the new entity would have a combined market 
share of around [30-40]%  in value  and volume.  
(94) Second, the market for metoprolol in Italy is largely genericised , with several 
suppliers,  and perceived as competitive  by most market participants .75 The market 
evolution shows that several generic companies have entered  the market since the 
originator products lost market exclusivity. Currently , besides the Parties, t here 
are five competing generic products and one  originator  product ( namely Daiichi 
Sankyo's Lopresor) . Thus, even though the Transaction may result in the loss of 
one generic competitor, the merged entity will still be facing active originator and 
generic competition. In part icular, post -Transaction, Daiichi Sankyo, which is 
perceived by market participants as the top supplier thanks  notably  to its well -
known brand,76 would rema in the market leader in terms of value (with a [30-
40]%  market share in 2017). The Parties will also face two other players, i.e. 
Novartis, and Stada, with market shares higher than DOC Generici (above [10-
20]% both in value and volume ).  
(95) Moreover, the mar ket investigation tested whether a sufficient number of 
alternative suppliers exists and how easy and quickly customers can switch 
suppliers. All responding customers indicated that they purchase metoprolol from 
several suppliers.77 Most customers also pointed out that the number of alternative 
supplies would remain sufficient  post-Transaction  regardless of the galenic 
form .78 
(96) Third , the market investigation indicated that the Parties are not close 
competitors, as DOC Generici's generic metoprolol competes more close ly with 
the other generics of the same medicine than with Recordati's originator Seloken.  
In particular, price and brand recognition are considered as key parameters of 
competitio n by  most respondents and Recordati's originator product is 
differe ntiated from generics due to its established brand and a certain degree of 
customer loyalty.79 The market investigation did not point out other differences 
between the originator and the generic product  over and above brand recognition 
and price80. A custome r indicated that the choice of metoprolol products is 
between the generics and originator products81 and that the difference between 
originator and generics is that the latter’ s price list is lower.82 Also, price 
competition appears greater between generics than it is between generics and 
originator products. As previously explained in relation to other markets, under 
                                                 
75  Replies to question 34 questionnaire Q1 – Competitor and Replies to question 59 of questionnaire Q2 
– Customers - Italy.  
76  Replies t o question 36 questionnaire Q1 – Competitors.  
77  Replies to question 65 of questionnaire Q2 – Customers - Italy 
78  Replies to question 68 of questionnaire Q2 – Customers - Italy.  
79  Replies to question 37 questionnaire Q1 – Competitors.  
80  Replies to quest ion 37 questionnaire Q1 – Competitors.  
81  Replies to question 63 of questionnaire Q2 – Customers - Italy.  
82  Replies to question 59.1 of questionnaire Q2 – Customers - Italy 
 
23 the national regulation,  only the lowest price among the prices of off -patent 
medicina l products is reimbursed and if patients choos e to buy more expensive 
originator products, they must  pay the price difference . Due to this feature, price 
competition on the Italian metoprolol market takes place more intensely between 
the different generic supplie rs, which are numerous and will continue to exert 
competitive pressure on the merged entity.  
(97) Fourth , the market investigation suggests that, due to the difference in galenic 
form, the Parties  are not close competitors at molecule level . There are t hree 
different galenic forms for metoprolol: class A ( oral solid ordinary), […]*  B (oral 
solid long acting ), and class F (parenteral ordinary ). In Italy, t he Parties' activities 
overlap only with respect to one of them: DOC Generici's products fall within the 
NFC1 A class and Recordati 's products fall within classes A, B and F. The replies 
to the market investigation are not conclusive to the extent to which different 
galenic forms are substitutable83. Regarding the parent eral metoprolol, it is 
unlikely that the merged entity will have any incentive to suspend or delay its 
supply to customers in Italy for the sake of potentially maximising the profits of 
the other forms, which are already facing significant competition.  
(98) Finally, the Commission notes that all informative respondents consider that  the 
impact of the Transaction will be " neutral " on the metoprolol market in Italy  
regardless of the galenic form .84 
(99) Based o n the above  considerations , in particular the fact that the overlap is 
moderated and that the Parties are not close competitors , the Commission 
concludes  that the Transaction does not raise serious doubts as to its compatibility 
with the internal market in relation to the supply of metoprolol in Italy  
irrespective of whether the market is subdivided by galenic form . 
Metoprolol – Iceland  
(100)  In Iceland the Transaction will combine an originator product to be marketed by 
Recordati (Seloken) and Alvogen 's generic  metoprolol products (Metoprolol 
Succinate Teva and Metoprolol Tartrate Teva ). 
(101)  Earlier in 2018, Alvogen began distributing Teva's generic metoprolol -based 
products  in Iceland, which was  previously distributed by Medical Limited (a 
Lyfis subsidiary) on behalf of Ratiopharm (a Teva subsidiary). This followed 
Alvogen's acquisition of a portfolio of products from Teva as a consequence of 
divestment commitments in case M.7746 - Teva/ Allergan  Generics85. The 
acquisition agreement include d provision for transfer of the marketing 
authorisation for metoprolol in Iceland from R atiopharm to Alvogen.   
                                                 
83  Replies to question 58 of questionnaire Q2 – Customers - Italy.  
84  Replies to q uestion 69 of questionnaire Q2 – Customers – Italy and question 40 of questionnaire Q1 - 
Competitors.  
85  Case M.7746 — Teva/Allergan Generics  
* Should read: “class”  
 
24 (102)  As regards Recordati, it acquired the rights to sell AstraZeneca's metoprolol -
based products in Icelan d in 2017.  […]  
(103)  The Parties claim that i n Iceland there is currently no overlap , as Recordati's sales 
will begin in […]. Nevertheless , based on the historical sales figures achieved by 
the previous distributor of AstraZeneca's and Teva's metoprolol in Iceland, the 
Parties' combined market share  is between [60-70]%  (in volume) and [70-80]%  
(in value) in 2017.  
(104)  The Commission considers that,  concerning the metoprolol market in Iceland  and 
its potential sub -segments86, the Transaction does not  raise serious doubts as to it s 
compatibility with the internal market for the following reasons.  
(105)  First, despite the small size of the metoprolol market in Iceland (EUR […] in 
2017), the Parties face several generic competitors active, namely Artasan Ehf 
([10-20]%  in value and [20-30]%  in volume), followed by Lyfis Ehf ( [5-10]% in 
value and [5-10]%  in volume) and Icepharma Hf ( [0-5]% in value and [0-5]% in 
volume). Pharmacies consider that the number of alternative metoprolol suppliers 
would be sufficient post-Transaction.87 Moreover, according to most responding 
pharmacies, it is easy to switch suppliers of metoprolol.88 It was notably pointed 
out that suppliers provide a next -day-delivery on workdays making it easy and not 
long to switch.89  
(106)  Second, the mark et investigation showed that the Parties are not close 
competitors, as Alvogen's generic metoprolol competes more close ly with 
multiple other generics of the same medicine than with the Recordati's originator 
Seloken. This is corroborated by several elemen ts. 
(107)  In the first place, the market investigation indicated that Recordati's originator 
product is differentiated from generics due to its established brand and a certain 
degree of customer loyalty. The respondents pointed out brand recognition as a 
particu lar advantage of the originator product in comparison with generic 
products. This is in line with the Notifying Party ’s claims that consumers easily 
switch between generics  but are more reluctant to switch away from the originator 
drug. A customer indicated that many people choose the original brand -name 
product over the generic version only because they dislike generic medicines .90 
(108)  In the second place, as shown in Table 2 above, the Parties' combined market 
share has significantly decreased over the  past three years ( -[10-20]%  in value 
and -[20-30]% in volume in 2017 compared to 2015). This is mainly due to the 
declining market shares of Alvogen's generic product ( -[10-20]%  in value and -
[20-30]% in volume over the 2015 -2017 period) to the benefit of  several generic 
competitors. For example, in the last three years the Parties’ largest competitor 
Artasan Ehf more than doubled its market presence ( +[10 -20]%  in value and 
+[10 -20]%  in volume in 2017 compared to 2015). At the same time, the previous 
                                                 
86  On this market, the Parties' activities overlap both at molecule and galenic form levels . 
87  Replies to question 21 and 21.1 of questionnaire Q3 – Customers – Iceland.  
88  Replies to question 20 of questionnaire Q3 – Customers – Iceland.  
89  A reply to question 20.1 of questionnaire Q3 – Customers – Iceland  
90  A reply to question 21.1 of questionnaire Q3 – Customers – Iceland.  

 
26 stated that “the price will not lower because both products are very strong and 
they will probably not increase because of competition (for metoprolol succinat 
Teva) and because of governmental price roof (Seloken Zoc) ”.93  
(112)  Based on the above considerations , , the Commission concludes that the 
Transaction does not give rise to serious doubts as to its compatibility with the 
internal market in relation to the  supply of metoprolol in Iceland  irrespective of 
whether the market is subdivid ed by galenic form . 
Metoprolol – Romania  
(113)  The overlap on the metoprolol market i n Romania is between an originator 
product (Betaloc and Betaloc ZOK), supplied by Recordati, and Al vogen’s  
generic product ( Alvogen LPH ).  Recordati acquired the rights to sell Betaloc and 
Betaloc ZOK ( AstraZeneca's metoprolol -based products ) in 2017 . Recordati has 
already started supplying metoprolol in Romania but […]. 
(114)  With respect to the supply of metoprolol in Romania, t he Not ifying Party points 
out that some interchangeable use of metoprolol and bisoprolol  has been noted in 
the literature and claims that the merged entity will be constrained by competing 
molecules, even if they do  not belong to the same relevant product market. 
However, considering that neither the Notifying Party nor the market 
investigation produced conclusive evidence that the metoprolol  and bisoprolol 
were not only potential therapeutic substitutes, but were actual, economic 
substitutes, the Commission cannot exclude that the competitive constraints are 
limited to metoprolol products. Therefore, the subsequent assessment takes into 
account the candidate market for medicines with metoprolol as the active 
ingredient.  
(115)  The Notifying Party also claims that despite the  combined market shares of the 
Parties (resp ectively [70-80]% in value and [60-70]% in volume in 2017),  the 
Transaction is unlikely to have a material impact on competition because the 
merged entity would  combine a n originator  drug with a generic drug, with the 
remaining generic suppliers being a so urce of competitive pressure on the market.  
(116)  The Commission considers that concerning the market for metoprolol in 
Romania,94 the Transaction does not raise serious doubts as to it s compatibility 
with the internal market for the following reasons.  
(117)  First, the market for metoprolol in Romania is highly competitive. The 
Commission notes that the Romanian metoprolol market, which decreased in 
value from EUR […] million in 2015 to EUR […] million in 2017, is largely 
genericised. The market investigation indicated that metoprolol is an old molecule 
and there are multiple generic companies on the market .95 In this regard, the 
Transaction leads to a merger  of one of the originator suppliers with one of the 
                                                 
93  A reply to question 21.1 of questionnaire Q3 – Customers – Iceland.  
94  At galenic form level, the Parties' activities do not overlap on this market.  
95  A reply to question 68 of questionnaire Q1 – Competitors.  
 
27 many generic companies. Post-Transaction , 10 competit ors will supply 
metoprolol -based  products , one of which (Servier) offers another  originator 
product . The three larger competitors  have market shares in value respectively of 
[10-20]%, [5 -10]%  and [5-10]%. The largest of these , Sun Pharma commands a 
higher market share in value ([10-20]%)  than Alvogen . Seven  additional smaller 
competitors  will also remain  active on the market. The market investigation 
showed that they exert su fficient competitive pressure  on the Parties  and most 
customers consider that the number of alternatives suppliers would remain 
sufficient post -Transaction.96 
(118)  Furthermore, the Commission notes that the new entity will also face competitive 
constraints from potential competitors that could enter the market within a short  
time frame. This applies in particular to Slavia, a generic provider, which has a 
marketing authorization for metoprolol in Romania and could therefore enter the 
market segment at any time . The Parties also submit that a number of firms that 
either (i) have supplied metoprolol in Romania in the past (such as Arena Group, 
Fabiol, Incdcf, Laropharm, Medico Uno , and Teva)  or (ii) are selling metoprolol 
in neighbouring geographic markets (Bulgaria, Croatia, Czech Republic, 
Hungary, Poland, Slovakia, Slovenia) (such as Dipharm, Biofarm, Bioton Group, 
Cefarm.Lab) are likely to have the relevant expertise to (re-)enter the Romanian 
metoprolol market within a short timeframe.  
(119)  Customers rated the market conditions for the supply of metoprolol in Romania as 
competit ive.97 In their view many and significant players are present on the 
market, which “insures price competition for the molecule”.98 A customer states 
that “ the prices are really low and there are a lot of suppliers and discounts to 
make a product more desirab le that the one produced by the competition ”.99 
Competitors described the metoprolol market as “ a crowded market ”,100 
particularly in relation to the oral solid ordinary form.  
(120)  Pharmacies multisource metoprolol from several suppliers.101 The typical 
duration of the contracts is one year, with a possibility for extension.102 showing 
that they can be changed fairly quickly.  The fact that pharmacies can negotiate 
discounts103 demonstrates that they can exert pressure on the suppliers and further  
intensify competition.  
(121)  Second , the Parties's respective metoprolol products are not close substitutes.  
(122)  In the first place, the market investigation suggests that, due to the difference in 
galenic form, the Parties' products are not close therapeutic subst itutes. Alvogen's 
products fall within the NFC1 A class (oral solid ordinary) and the Recordati's 
products fall within classes B (oral solid long acting) and F (parent eral ordinary).  
                                                 
96  Replies to question 20 of questionnaire Q4 to customers in Romania.  
97  Replies to question 11 of questionnaire Q4 – Customers – Romania.  
98  Replies to question 11.1 of questionnaire Q4 – Customers – Romania.  
99  Replies to question 11.1 of questionnaire Q4 – Customers – Romania.  
100  A reply q 65.1 Q1  
101  Replies to q 7 Q4 – Customers - Romania  
102  Replies to question 8 of  questionnaire Q4 – Customers – Romania.  
103  Replies to question 9.1 of questionnaire Q4 – Customers – Romania.  
 
28 In other words, the  Parties' galenic form s do not overlap . Though not con clusive, 
the replies of the market participants  show that substitutability between the 
different galenic forms  may be somewhat limited . On the one hand, some 
pharmacists explained that the ordinary and the long -acting  forms can be 
considered similar produc ts, as they are prescribed alternatively for the same 
diagnosis104, and there is a large base of patients who have long -term treatment.105 
On the other hand, the choice of galenic form is made by the physicians, after 
which the pharmacists cannot automatically substitute it with another form but 
must dispense the prescribed pharmaceutical form .106 Furthermore, due […]* an 
entirely different mode of administration, the parenteral form of me toprolol is an 
even more remote substitute, suitable only for very specific patient populations.  
(123)  In the second place, the respondents pointed out brand recognition as a particular 
advantage of the originator product in comparison with generic products.107 
(124)  In the third place, although customers are price sensitive, there appears to be more 
limited price competition between Recordati's originator  product and other 
metoprolol products, whether generic or originator (Servier). Both suppliers and 
customers affirme d that Romanian customers are very sensitive to prices and that 
price is therefore one of the main factors for customers' choice of metoprolol 
suppliers .108 High price competition is driven by generic penetration due to a high 
number of generic companies .109 These observations appear to be particularly 
relevant for competitive dynamics between generic metoprolol (including 
Servier's originator product), but do not explain the fact that Recordati's originator 
metoprolol enjoys a considerable price premium over o ther metoprolol 
products110 while maintaining a significant market share.  
(125)  Limited price pressure on Recordati can be explained by brand recognition, as 
well as the limited therapeutic differentiation (not all generics, including Alvogen, 
supply the long act ing galenic form).  According to the pharmacies responding to 
the investigation,  customers’ choice is to a larger extend determined by 
branding111, as certain patients  specifically  ask for a certain product or brand.112  
(126)  Finally, the Commission found that Recor dati's originator products (Betaloc) are 
already priced at the maximum permissible level under the national regulatory 
regime. Pursuant to Romania's pharmaceutical regulatory pricing regime, there 
are three different reference prices set for each given pro duct – the manufacturer's 
price, wholesale price and retail price. General practice for originators is to price 
at the maximum permissible level for all three prices. Betaloc, the Target's 
originator product in Romania, is already priced at the maximum ret ail price 
                                                 
104  A reply to question 10 of questionnaire Q4 – Customers – Romania.  
105  A reply to question 10 of questionnaire Q4 – Customers – Romania.  
106  Replies to question 11 of questionnaire Q4 – Customers – Romania.  
107  Replies q 69 Q1 and Replies to question 14 of questionnaire Q4 – Customers – Romania.  
108  A reply to  question 66 of questionnaire Q1 – Competitors.  
109  A reply to question 8 of questionnaire Q1 – Competitors.  
110  In Romania generic providers can set prices only up to 35% below the price of the originator drug . 
111  A reply to question 14 of questionnaire Q4 – Customers – Romania.  
112  A reply to question 10 of questionnaire Q4 – Customers – Romania . 
* Should read: “to”  

 
30 (131)  The Notifying Party claims that should the merged entity not enter th e […] 
market with generics, it would not be able to have a market offering fo r those 
customers that consider  switching to lower priced generics. In other words, the 
merged entity would forego attracting part of the dema nd by not entering the 
market, thus decreasing its profitability.  
(132)  The Notifying Party indicated that it intends to commercialise its generic product 
once the regulatory procedure is completed.  
(133)  The market investigation showed that several  other  […]-based  products are 
currently undergoing authorisation procedures , which has been confirmed by the 
Agenza Italiana del Farmaco . Consequently, once on the market these products 
will exert competitive pressure on the merged entity’s originator product even if 
the m erged entity were to discontinue or delay the development of its generic 
product in an attempt to preserve its marketed originator product sales.  
(134)  Thus, in the light of the above, the Transaction does not raise serious doubts as to 
its compatibility with t he internal market in relation to the development of […]-
based  generic pharmaceuticals in the EEA.  
[…] 
(135)  […] 
(136)  In relation to […], Recordati holds [90-100]% of the market in Czech  Republic, 
Estonia, Greece, Ireland, Latvia, Lithuania, Poland, Romania and Slovakia.  In 
Germany, France, Italy, Portugal and Spain the Target’s share of sales is above 
35%.   
(137)  In relation to […], and similarly to […], the Notifying Party claims that should  
the merged entity not enter the […] market with generics, it would not be able to 
have a market offering for those customers that consider switching to lower 
priced generics. In other words, the merged entity would forego attracting part of 
the demand by not entering the market, thus decreasing its profitability. The 
Notifying Party also indicated that it intends to commercialise its generic product 
once the regulatory procedure is completed.  
(138)  The […] market at both the EEA and in a number of Member States is not yet 
genericised as Recordati’s product is still patent protected in many member 
States. Generic products are, however, under development. The Notifying Party 
indicated and the Commission notes that it has submitted a marketing 
authorisation application for a generic version of its originator […] product under 
the centralised procedure.  Furthermore, as is generally observed in the 
pharmaceutical industry  towards the expir y of patent  and market exclusivity , the 
market investigation showed  that several companies are developing […]-based 
products.116 Consequently, once on the market these products will exert 
competitive pressure on the merged entity’s originator product even if  the merged 
                                                                                                                                                 
115  Apart from Italy, the other EEA Member State where the Recordati is active with […] is Portugal, 
where its 2017 share of sales in value was [0-5]% ([0-5]% in volume).  
116  See replies to question 74.2 of questionnaire Q1 to competitors.  
 
31 entity were to discontinue or delay the development of its generic product in an 
attempt to preserve its marketed originator product sales.   
(139)  Thus, in the light of the above, the Transaction does not raise serious doubts as to 
its compatibility with the internal market with respect to development of the […]-
based  generic pharmaceuticals in the EEA.  
 
4.2.2.  Vertical links  
(140)  The Transaction creates some potential vertical links  between  Recordati’s 
activities on the market for finished dose pharmaceutical products (upstream 
market s) and the provision of hospital services by CVC Fund Portfolio 
Companies (downstream market s). Potential vertical links between the Parties 
were considered in each geographic market where Recordati and relevant CVC 
Funds' Portfoli o Companies are active. Vertically affected markets arise in France 
and in Greece.  
France (Elsan and Recordati ) 
(141)  Downstream, the market share of Elsan , a CVC Fund Portfolio Company  active in 
the French private hospitals market , does not exceed 30% under any  plausible 
market definition .117  
(142)  Upstream, Recordati sells a number of products to French hospitals and holds a 
monopoly for the supply of methadone, phosphoneuros, citrafleet, recholan, 
logimax, otofa, adiazine, nordaz, urispas, basdene, abufene, and hexas pray. For 
four other products – urorec, seloken, polydexa and ery, Recordati's market shares 
in France are above 30% . 
(143)  The Notifying Party  explained that the monopoly position is due to historical 
reasons – either no other competitor has decided to develop and market a 
competing product based on the same molecule or competitors have decided it 
was not commercially interesting to maintain the se products in the market. There 
are, however,  no intellectual property constraints which would prevent an 
interested third party from procuring Active Pharmaceutical Ingredients (APIs) 
and manufacturing and selling originator or generic products based on the 
molecules, subject to obtaining the required marketing authorisations and other 
permits.  
(144)  Further , the Commission notes that Recordati currently does not supply any of the 
molecules referred to in recital […]*  to Elsan and will not have any incentive t o 
provide its products on an exclusive basis only to Elsan for the future, as it is 
hardly thinkable that the merged entity would be able to divert patients to a 
specific hospital chain by refusing supply of medicines to other hospitals. It 
would therefore  run against the merged entity's commercial interests to attempt 
refusing supplies to Elsan's competitors. In addition, except for methadone (2017 
sales of EUR […]), Recordati's sales to hospital are negligible (well below EUR 
                                                 
117  See the Notifying Party's reply to RFI3 question 7.b.  
* Should read: “(142)”  
 
32 0.5 million per molecule). Ba sed on these considerations, the Commission 
considers it unlikely that the Parties will have ability to implement foreclosure 
strategies in respect of the molecules.   
Greece (Metropolitan and Recordati ) 
(145)  Downstream , Metropolitan's market share slightly exceed s 30% only in one 
plausible market, i.e. the Greek private general hospital market ([30-40]%) .118 
Upstream, e ven though Recordati generates some sales to the hospital network in 
Greece, its market shares do not exceed 30% under any plausible product ma rket 
definition. Taking into account also that Metropolitan's purchases from the Target 
are negligible,  the Commission considers that the Transaction does not give rise 
to risks of input or customer foreclosure.  
Conclusion  
(146)  Based on the foregoing considera tions of the vertical links, the Commission 
considers that the Transaction does not raise serious doubts as to its compatibility 
with the internal market and the EEA Agreement.  
5. CONCLUSION  
(147)  For the above reasons, the Commission has decided not to oppose the notified 
operation and to declare it compatible with the internal market and with the 
functioning of the EEA Agreement . This decision is adopted in application of 
Article 6(1)(b) of the Merger Regulation and Article 57 of the EEA Agreement.  
 
 
For the Commi ssion  
(Signed)  
Margrethe VESTAGER  
Member of the Commission  
 
 
 
 
 
 
 
 
 
 
 
 
 
                                                 
118  See the Notifying Part y's reply to RFI3 question 7.b. Metropolitan's market share estimates include the 
Hygiea Group, which is currently in the process of being acquired by Metropolitan.