Patent Listing Disputes

Current through January 12, 2024

Established Drug Product

Name

NDA Number NDA Holder Strength(s) Relevant U.S. Patent Number(s) Type of Patent Claim Original Use Code (if applicable) Revised Use Code (if applicable) D

cyclosporine 050790 Abbvie 0.05% 8292129, 8561859, 9669974, 9676525 Disputes Not Related to Use Code N/A N/A 

budesonide; formoterol

fumarate dihydrate 021929 Astrazeneca 0.08MG/INH; 0.0045MG/INH 7587988, 8387615, 8528545, 8616196, 8875699 Disputes Not Related to Use Code N/A N/A 

albuterol sulfate; ipratropium

bromide 021747 Boehringer Ingelheim EQ 0.1MG BASE/INH; 0.02MG/INH 7284474, 7396341, 7837235, 7896264, 8733341, 9027967 Disputes Not Related to Use Code N/A N/A 

ipratropium bromide 021527 Boehringer Ingelheim 0.021MG/INH 8474447 Disputes Not Related to Use Code N/A N/A 

tiotropium bromide 021395 Boehringer Ingelheim EQ 0.018MG BASE/INH 7694676, 9010323 Disputes Not Related to Use Code N/A N/A 

tiotropium bromide 021936 Boehringer Ingelheim EQ 0.00125MG BASE/INH 7284474, 7396341, 7837235, 7896264, 8733341, 9027967 Disputes Not Related to Use Code N/A N/A 

fluticasone propionate 021433 Glaxo Grp Ltd 0.044MG/INH 7500444 Disputes Not Related to Use Code N/A N/A 

fluticasone propionate;

salmeterol xinafoate 021254 Glaxo Grp Ltd 0.115MG/INH; EQ 0.021MG BASE/INH 7500444 Disputes Not Related to Use Code N/A N/A 

albuterol sulfate 020983 Glaxosmithkline EQ 0.09MG BASE/INH 7500444 Disputes Not Related to Use Code N/A N/A 

fluticasone furoate 205625 Glaxosmithkline 0.1MG/INH 8113199, 8161968, 8534281, 8746242 Disputes Not Related to Use Code N/A N/A 

epinephrine 201739 Kaleo Inc EQ 0.15MG/ DELIVERY

7731686, 7731690, 7749194,

8016788, 8920377, 8926594,

9238108, 10960155

Disputes Not Related to

Use Code N/A N/A 

epinephrine 020800 Impax EQ 0.15MG/ DELIVERY 7905352, 10166334 Disputes Not Related to Use Code N/A N/A 

epinephrine 019430 Mylan Specialty LP 0.15MG/DELIVERY, 0.3MG/DELIVERY 7449012, 7794432, 8048035, 9586010 Disputes Not Related to Use Code N/A N/A 

beclomethasone

dipropionate 207921 Norton Waterford 0.04MG/INH

8132712, 10022509, 10022510,

10086156, 10561808, 10695512,

11395889

Disputes Not Related to

Use Code N/A N/A 

albuterol Sulfate 021457 Teva Branded Pharm EQ 0.09MG BASE/INH

8132712, 9463289, 9808587,

10022509, 10022510, 10086156,

10561808, 10695512, 11395889

Disputes Not Related to

Use Code N/A N/A 

albuterol Sulfate 205636 Teva Branded Pharm EQ 0.09MG BASE/INH

8651103, 8978966, 9216260,

9463288, 9731087, 9782550,

9782551, 10022510, 10124131,

10561808, 10569034, 10765820,11000653, 11266796, 11351317,

11357935, 11439777, 11464923

Disputes Not Related to

Use Code N/A N/A 

beclomethasone

dipropionate 020911 Teva Branded Pharm 0.04MG/INH

9463289, 9808587, 10022509,

10022510, 10086156, 10561808,

10695512, 11395889

Disputes Not Related to

Use Code N/A N/A 

betamethasone

dipropionate; calcipotriene 213422 MC2

0.064%0.005% 11638711 Disputes Not Related to Use Code N/A N/A 

adapalene; benzoyl peroxide 022320 Galderma Labs LP 0.1% 2.5% 8445543 Disputes Not Related to Use Code N/A N/A 

isavuconazonium sulfate 207500 Astellas 74.5MG 10812238 Disputes Not Related to

Use Code N/A N/A 
Patent Listing Disputes

Current through January 12, 2024

Established Drug Product

Name

NDA Number NDA Holder Strength(s) Relevant U.S. Patent Number(s) Type of Patent Claim Original Use Code (if applicable) Revised Use Code (if applicable) D

propofol 019627 Fresenius Kabi USA 10MG/ML 8476010 Disputes Not Related to Use Code N/A N/A 

phentolamine mesylate 022159 Septodont Holding 0.4MG/1.7ML 7229630, 7575757 Disputes Not Related to Use Code N/A N/A 

epinephrine 205029 Belcher 1MG/ML 10004700, 10039728 Disputes Not Related to Use Code N/A N/A 

epinephrine 205029 BPI Labs LLC 1MG/ML 9283197 Disputes Not Related to Use Code N/A N/A 

amifampridine phosphate 208078 Catalyst Pharmaceuticals Inc 10MG 10636088 Disputes Not Related to Use Code N/A N/A 

pitolisant hydrochloride 211150 Harmony Biosciences LLC 4.45MG 17.8MG 8486947 Method of Use U‐1102: Method of treating cataplexy in patients with narcolepsy N/A 

ganaxolone 215904 Marinus Pharmaceuticals Inc 50MG/ML 8022054 Disputes Not Related to Use Code N/A N/A 

baricitinib 207924 Eli Lilly Co

1MG2MG4MG

9089574, 11045474 Disputes Not Related to Use Code N/A N/A 

tipiracil hydrochloride;

trifluridine 207981 Taiho Oncology Inc 6.14MG; 15MG 8.19MG; 20MG 10960004 Method of Use U‐2642: Method of treating cancer by detecting a creatinine clearance of a patient and administering Lonsurf N/A 

tipiracil hydrochloride;

trifluridine 207981 Taiho Oncology Inc 6.14MG; 15MG 8.19MG; 20MG 10456399 Method of Use U‐2642: Method of treating cancer by detecting a creatinine clearance of a patient and administering Lonsurf N/A 

fostamatinib disodium 209299 Rigel Pharmaceuticals

Inc

100MG150MG 8263122, 8652492 Disputes Not Related to Use Code N/A N/A 

famotidine; ibuprofen 022519 Horizon Medicines LLC 26.6MG; 800MG 8067033 Disputes Not Related to Use Code N/A N/A 

metaxalone 013217 King Pharms 800MG 7122566 Disputes Not Related to Use Code N/A N/A 

memantine hydrochloride 022525 Allergan Sales LLC

7MG

14MG21MG28MG

8168209, 8173708, 8283379,

8329752, 8362085, 8598233

Disputes Not Related to

Use Code N/A N/A 

epinephrine 201739 Kaleo Inc

0.1MG

0.15MG

0.3MG

10824938 Disputes Not Related to

Use Code N/A N/A 

cangrelor 204958 Chiesi 50MG/VIAL 8680052 Method of Use

U‐2869: IV Administration of cangrelor before PCI and

continuous infusion for at least 2 hours or the duration of

the PCI and, during or after the continuous infusion,

administration of a loading dose of ticagrelor or an

equivalent therapy (per labeling)

U‐2979: Method comprising IV administration of

cangrelor before PCI then continuous infusion for at

least 2 hours or the duration of PCI and, during or

after continuous infusion, administration of a

loading dose of ticagrelor, or an equivalent method

latanoprost; netarsudil

dimesylate 208259 Aerie Pharms Inc 0.02%/0.005% 10654844 Disputes Not Related to Use Code N/A N/A 

netarsudil dimesylate 208254 Aerie Pharms Inc 0.02% 10654844 Disputes Not Related to Use Code N/A N/A 

dapagliflozin; metformin

hydrochloride 205649 Astrazeneca

5MG/ 500MG

5MG/ 1000MG10MG/ 500MG

10MG/ 1000MG

2.5MG/1000MG

6515117 Disputes Not Related to

Use Code N/A N/A 
Patent Listing Disputes

Current through January 12, 2024

Established Drug Product

Name

NDA Number NDA Holder Strength(s) Relevant U.S. Patent Number(s) Type of Patent Claim Original Use Code (if applicable) Revised Use Code (if applicable) D

cangrelor 204958 Chiesi 50MG/VIAL 8680052 Method of Use

U‐1715: P2Y12 Platelet Inhibitor for use as adjunct to

percutaneous coronary intervention to reduce risk of

various diseases/conditions in patients not treated with

a P2Y12 platelet inhibitor and not given a glycoprotein

IIb/IIIA inhibitor

U‐2869: IV Administration of cangrelor before PCI

and continuous infusion for at least 2 hours or

the duration of the PCI and, during or after the

continuous infusion, administration of a loading

dose of ticagrelor or an equivalent therapy (per

labeling)

fingolimod hydrochloride 022527 Novartis EQ 0.5MG BASE 9187405 Method of Use U‐2613: Treatment of Relapsing‐Remitting Sclerosis (MS) N/A 

paliperidone palmitate 022264 Janssen Pharms

39MG/0.25ML,

78MG/0.5ML,

117MG/0.75ML,

156MG/ML

9439906 Method of Use U‐543: Treatment of Schizophrenia

U‐2757: Dosing regimen for the treatment of

schizophrenia in adults by administering two

loading doses of paliperidone palmitate followed

by maintenance dose(s)

paliperidone palmitate 022264 Janssen Pharms

39MG/0.25ML,

78MG/0.5ML,

117MG/0.75ML,

156MG/ML

9439906 Method of Use

U‐1901: Treatment of Schizoaffective Disorder as a

Monotherapy and as an adjunct to mood stabilizers or

antidepressants

U‐2758: Dosing regimen for the treatment of

schizoaffective disorder in adults as a

monotherapy and as an adjunct to mood

stabilizers or antidepressants by administering

two loading doses of paliperidone palmitate

followed by maintenance dose(s)

glatiramer acetate 020622 Teva Pharms USA 40MG/ML 8232250, 8399413, 8969302, 9155776, 9402874 Disputes Not Related to Use Code N/A N/A 

empagliflozin; linagliptin 206073 Boehringer Ingelheim 10MG; 5MG, 25MG; 5MG 10406172 Method of Use U‐1652: Method of Treating Type 2 Diabetes Mellitus by administering Linagliptin in combination with

empagliflozin and metformin

N/A 

empagliflozin 204629 Boehringer Ingelheim 10MG 25MG 10406172 Method of Use U‐1652: Method of Treating Type 2 Diabetes Mellitus by administering Linagliptin in combination with empagliflozin and metformin N/A 

sodium oxybate 021196 Jazz Pharms 500MG/ML 10213400 Method of Use

U‐2499: Method of reducing adverse effects in patients

suffering from excessive daytime sleepiness and/or

cataplexy in narcolepsy who are concomitantly

administered sodium oxybate and divalproex sodium

N/A 

sodium oxybate 021196 Jazz Pharms 500MG/ML 8772306, 9050302, 9486426 Method of Use

U‐1532: Method of treating excessive daytime

sleepiness and/or cataplexy in narcolepsy patients with

sodium oxybate when divalproex sodium is

concomitantly administered

N/A 

sodium oxybate 021196 Jazz Pharms 500 MG/ML 8731963 Method of Use

U‐1110: Method of treating a patient with a

prescription drug using a computer database in a

computer system for distribution

N/A 

abiraterone acetate 202379 Janssen Biotech 250MG

500MG

8822438 Disputes Not Related to

Use Code N/A N/A 

sodium oxybate 021196 Jazz Pharms 500MG/ML 7668730, 7765106, 7765107, 7895059, 8457988, 8589182 Disputes Not Related to Use Code N/A N/A 

ramelteon 021782 Takeda Pharms USA 8MG 10098866 Disputes Not Related to

Use Code N/A N/A 

fexofenadine hydrochloride 201373 Sanofi Aventis US 30MG/5ML 8933097 Disputes Not Related to Use Code N/A N/A 

cyclosporine 050790 Allergan 0.05% 9669974, 9676525 Disputes Not Related to Use Code N/A N/A 

nateglinide 021204 Novartis 60MG 120MG 6559188, 6878749 Disputes Not Related to Use Code N/A N/A 

avibactam sodium;

ceftazidime 206494 Allergan Sales LLC EQ 0.5GM BASE; 2 GM/VIAL 8969566 Disputes Not Related to Use Code N/A N/A 

trospium chloride 022103 Allergan 60MG 7410978, 7759359, 7763635, 7781448, 7781449 Disputes Not Related to Use Code N/A N/A 

pirfenidone 208780 Genentech Inc

267MG534MG801MG

8383150 Disputes Not Related to

Use Code N/A N/A 

metformin hydrochloride 021748 Santarus Inc 500MG, 1GM 6723340 Disputes Not Related to Use Code N/A N/A 

empagliflozin; linagliptin 206073 Boehringer Ingelheim 10MG; 5MG, 25MG; 5MG 8673927 Method of Use U‐1772: Method of treating type 2 diabetes mellitus by administering linagliptin in combination with empagliflozin None 
Patent Listing Disputes

Current through January 12, 2024

Established Drug Product

Name

NDA Number NDA Holder Strength(s) Relevant U.S. Patent Number(s) Type of Patent Claim Original Use Code (if applicable) Revised Use Code (if applicable) D

empagliflozin; linagliptin 206073 Boehringer Ingelheim 10MG; 5MG, 25MG; 5MG 9173859 Method of Use U‐1652: Method of treating type 2 diabetes mellitus by administering linagliptin in combination with empagliflozin and metformin None 

tadalafil 022332 Eli Lilly Co 20MG 6821975, 7182958 Disputes Not Related to Use Code N/A N/A 

metformin hydrochloride 021748 Santarus Inc 500MG 1GM 6488962 Disputes Not Related to Use Code N/A N/A 

ropivacaine hydrochloride 020533 Fresenius Kabi USA

200MG/100ML

(2MG/ML),

400MG/200ML

(2MG/ML)

7828787, 7857802, 8118802,

8162915

Disputes Not Related to

Use Code N/A N/A 

metaxalone 013217 King Pharms 880MG 7122566 Disputes Not Related to Use Code N/A N/A 

colchicine 204820 Hikma Intl Pharms 0.6MG 8927607, 9399036, 9555029,

9675613, 9789108

Method of Use U‐1020: Method of using colchicine for the prophylaxis of gout flares None 

acetaminophen 022450 Mallinckrodt IP 1GM/100ML (10MG/ML) 9610265 Method of Use U‐2000: Management of moderate to severe pain as an adjunct to opioid analgesics U‐2263: Modified dosing regimen for the management of moderate to severe pain with adjunctive opioid analgesics 

acetaminophen 022450 Mallinckrodt IP 1GM/100 ML (10MG/ML) 9399012 Method of Use

U‐1882: Management of mild to moderate pain,

management of moderate to severe pain as an adjunct

to opioid analgesics, reduction in fever through

analgesic and antipyretic activity

U‐2261: Modified dosing regimen for the

management of mild to moderate pain or

management of moderate to severe pain as an

adjunct to opioid analgesics

U‐2262: Modified dosing regimen for the

reduction of fever

dimethyl fumarate 204063 Biogen Idec Inc 120MG 240MG 7320999, 8759393 Disputes Not Related to Use Code N/A N/A 

tofacitinib citrate 208246 Pfizer Inc EQ 11MG BASE RE41783 Disputes Not Related to Use Code N/A N/A 

metformin hydrochloride 021748 Santarus Inc 500MG 1GM 8323692 Disputes Not Related to Use Code N/A N/A 

dapagliflozin 202293 Astrazeneca AB 5MG 10MG

6479065, 6495164, 6667061,

6824822, 6872700, 6956026,

7223440, 7456254, 7563871,

7612176, 7741269, 8216180,

8329648, 8431685, 8439864,

8461105, 8690837, 8712615,

8758292, 8827963, 8906851,

8998876, 9238076, 9320853

Disputes Not Related to

Use Code N/A N/A 

eslicarbazepine acetate 022416 Sunovion Pharms Inc

200MG400MG600MG800MG

9750747 Method of Use U‐2041: Treatment of partial‐onset seizures None 

dapagliflozin 202293 Astrazeneca AB 5MG 10MG 8685934 Method of Use

U‐1522: Treatment of type 2 diabetes mellitus in a

patient, wherein glycemic control (HbA1c < 7.0%) is not

achievable using one or more of insulin, metformin,

pioglitazone, or rosiglitazone

None 

dabigatran etexilate mesylate 022512 Boehringer Ingelheim

75MG

110MG150MG

7866474 Disputes Not Related to

Use Code N/A N/A 

metaxalone 013217 King Pharms 800MG 7122566 Disputes Not Related to Use Code N/A N/A 

dabigatran etexilate mesylate 022512 Boehringer Ingelheim

75MG

110MG150MG

9034822 Disputes Not Related to

Use Code N/A N/A