New ANDA Cases

Federal district court cases that are filed pursuant to the Hatch-Waxman Act

Fourth Quarter

GENERICally Speaking

This chart summarizes the case name, presiding judge, drug, and patents-at-issue in all federal district court cases that are filed pursuant to the Hatch-Waxman Act. It also includes the same information for proceedings before the Patent Trial and Appeal Board concerning Orange Book-listed patents.

Case Name Date Filed Judge Drug Patent No(s).
Novo Nordisk Inc. v. ScinoPharm Taiwan Ltd., 23-20935 (D.N.J.) Oct. 5, 2023 Hon. Esther Salas Victoza® (liraglutide recombinant solution injection) 8,114,833
9,265,893
Teva Branded Pharm. Products R&D, Inc. v. Amneal Pharms. of New York, LLC, 23-20964 (D.N.J.) Oct. 6, 2023 Hon. Claire C. Cecchi ProAir® HFA (albuterol sulfate inhalation aerosol) 8,132,712
9,463,289
9,808,587
10,561,808
10,695,512
11,395,889
Micro Labs Ltd. v. Hikma Pharms. USA Inc., 23-1138 (D. Del.) Oct. 11, 2023 Hon. Colm F. Connolly Mitigare® (colchicine capsules) 8,927,607
9,399,036
9,555,029
9,675,613
Fresenius Kabi USA, LLC v. Caplin Steriles Ltd., 23-1144 (D. Del.) Oct. 12, 2023 Hon. Maryellen Noreika Naropin® (ropivacaine HCl injection) 7,828,787
7,857,802
Bristol-Myers Squibb Co. v. Zydus Pharms. (USA) Inc., 23-21098 (D.N.J.) Oct. 12, 2023 Hon. Renee Marie Bumb Sprycel® (dasatinib tablets) 7,491,725
8,680,103
Bayer Healthcare LLC v. Padagis Israel Pharms. Ltd., 23-1148 (D. Del.) Oct. 13, 2023 Hon. William C. Bryson Astepro® (azelastine HCl nasal spray) 8,071,073
8,518,919
9,919,050
Hikma Pharms. USA Inc. v. Cipla USA, Inc., 23-1157 (D. Del.) Oct. 13, 2023 Hon. Gregory B. Williams Kloxxado® (naloxone HCl nasal spray) 10,722,510
10,973,814
11,135,155
11,617,713
11,628,139
Celgene Corp. v. Accord Healthcare, Inc., 23-21189 (D.N.J.) Oct. 16, 2023 Hon. Susan D. Wigenton Revlimid® (lenalidomide capsules) 7,465,800
7,855,217
8,741,929
Pfizer Inc. v. Aurobindo Pharma Ltd., 23-1182 (D. Del.) Oct. 19, 2023 Hon. Gregory B. Williams Vyndaqel® (tafamidis meglumine capsules) 7,214,696
ZS Pharma, Inc. v. Alkem Labs. Ltd., 23-1187 (D. Del.) Oct. 20, 2023 Hon. Gregory B. Williams Lokelma® (sodium zirconium cyclosilicate for oral suspension) 11,738,044
ZS Pharma, Inc. v. Ascent Pharms. Inc., 23-1188 (D. Del.) Oct. 20, 2023 Hon. Gregory B. Williams Lokelma® (sodium zirconium cyclosilicate for oral suspension) 11,738,044
ZS Pharma, Inc. v. Lupin Ltd., 23-1189 (D. Del.) Oct. 20, 2023 Hon. Gregory B. Williams Lokelma® (sodium zirconium cyclosilicate for oral suspension) 11,738,044
ZS Pharma, Inc. v. Macleods Pharms. Ltd., 23-1190 (D. Del.) Oct. 20, 2023 Hon. Gregory B. Williams Lokelma® (sodium zirconium cyclosilicate for oral suspension) 11,738,044
ZS Pharma, Inc. v. Sandoz Inc., 23-1191 (D. Del.) Oct. 20, 2023 Hon. Gregory B. Williams Lokelma® (sodium zirconium cyclosilicate for oral suspension) 11,738,044
Taiho Pharm. Co., Ltd. v. Eugia Pharma Specialties Ltd., 23-1193 (D. Del.) Oct. 20, 2023 Hon. Colm F. Connolly Lonsurf® (trifluridine / tipiracil tablets) 9,943,537
Novo Nordisk Inc. v. Meitheal Pharms., Inc., 23-1195 (D. Del.) Oct. 20, 2023 Hon. Colm F. Connolly Victoza® (liraglutide recombinant solution injection) 8,114,833
9,265,893
Bayer Pharma AG v. Cipla Ltd., 23-1196 (D. Del.) Oct. 20, 2023 Hon. Richard G. Andrews Xarelto® (rivaroxaban tablets) 10,828,310
Dr. Reddy’s Labs., Inc. v. Novo Nordisk A/S, IPR2024-00009 (PTAB) Oct. 20, 2023 N/A Ozempic® (semaglutide subcutaneous solution) 10,335,462
Impact Biomedicines, Inc. v. Teva Pharms., Inc., 23-21385 (D.N.J.) Oct. 23, 2023 Hon. Michael E. Farbiarz Inrebic® (fedratinib capsules) 10,391,094
11,400,092
AbbVie Inc. v. Sandoz, Inc., 23-1212 (D. Del.) Oct. 25, 2023 Hon. Richard G. Andrews Orilissa® (elagolix sodium tablets) 11,542,239
11,690,845
11,690,854
11,707,464
Bayer Pharma AG v. Taro Pharm. Indus. Ltd., 23-1219 (D. Del.) Oct. 26, 2023 Hon. Richard G. Andrews Xarelto® (rivaroxaban tablets) 10,828,310
Orion Corp. v. Hetero USA Inc., 23-1221 (D. Del.) Oct. 26, 2023 Hon. Colm F. Connolly Nubeqa® (darolutamide tablets) 10,010,530
10,383,853
10,835,515
11,168,058
Endo Par Innovation Co. v. Deva Holding A.S., 23-21684 (D.N.J.) Oct. 31, 2023 Hon. Christine P. O’Hearn Adrenalin® (epinephrine injection) 9,119,876
9,295,657
Incyte Corp. v. Padagis Israel Pharms. Ltd., 23-21826 (D.N.J.) Nov. 2, 2023 Hon. Madeline Cox Arleo Opzelura® (ruxolitinib cream) 10,758,543
10,869,870
11,219,624
11,510,923
11,571,425
11,590,136
11,590,137
11,590,138
11,602,536
Sun Pharm. Indus. Ltd. v. Novo Nordisk A/S, IPR2024-00107 (PTAB) Nov. 2, 2023 N/A Ozempic® (semaglutide injection) 10,335,462
BeiGene USA, Inc. v. Pharmacyclics LLC, PGR2024-00009 (PTAB) Nov. 2, 2023 N/A Imbruvica® (ibrutinib capsules) 11,672,803
Takeda Pharms. U.S.A., Inc. v. Scilex Pharms. Inc., 23-1264 (D. Del.) Nov. 6, 2023 Hon. Richard G. Andrews Gloperba® (colchicine oral solution) 7,619,004
7,820,681
7,964,648
8,093,297
8,097,655
8,440,722
AbbVie Inc. v. Teva Pharms., Inc., 23-1268 (D. Del.) Nov. 7, 2023 Hon. Richard G. Andrews Oriahnn® (elagolix sodium / estradiol / norethindrone acetate capsules) 11,690,845
Actelion Pharms. Ltd. v. Mylan Pharms. Inc., 23-0088 (N.D.W.V.) Nov. 7, 2023 Hon. Thomas S. Kleeh Opsumit® (macitentan tablets) 7,094,781
10,946,015
Eli Lilly & Co. v. MSN Labs. Private Ltd., 23-1277 (D. Del.) Nov. 8, 2023 Hon. Colm F. Connolly Olumiant® (baricitinib tablets) 8,158,616
Novo Nordisk Inc. v. Dr. Reddy’s Labs., Ltd., 23-22112 (D.N.J.) Nov. 8, 2023 Hon. Esther Salas Victoza® (liraglutide recombinant solution injection) 8,114,833
9,265,893
Harmony Biosciences, LLC v. Lupin Ltd., 23-1286 (D. Del.) Nov. 9, 2023 Hon. Maryellen Noreika Wakix® (pitolisant HCl tablets) 8,486,947
8,207,197
Purdue Pharma L.P. v. Elite Labs., Inc., 23-22221 (D.N.J.) Nov. 9, 2023 Hon. Karen M. Williams OxyContin® (oxycodone HCl extended-release tablets) 9,763,933
9,770,416
9,492,389
9,492,391
9,492,392
9,492,393
9,775,808
11,304,908
11,304,909
9,073,933
9,522,919
10,407,434
9,775,811
9,763,886
11,298,322
Pfizer Inc. v. Dexcel Pharma Technologies Ltd., 23-1304 (D. Del.) Nov. 15, 2023 Hon. Colm F. Connolly Xeljanz® XR (tofacitinib citrate extended-release tablets) RE41,783
Catalyst Pharms., Inc. v. Inventia Healthcare Ltd., 23-22461 (D.N.J.) Nov. 17, 2023 Hon. Michael E. Farbiarz Firdapse® (amifampridine tablets) 10,626,088
10,793,893
11,060,128
11,268,128
11,274,331
11,274,332
Catalyst Pharms., Inc. v. Inventia Healthcare Ltd., 23-1331 (D. Del.) Nov. 20, 2023 Hon. Jennifer Choe-Groves Firdapse® (amifampridine tablets) 10,626,088
10,793,893
11,060,128
11,268,128
11,274,331
11,274,332
AbbVie Inc. v. Hetero USA, Inc., 23-1332 (D. Del.) Nov. 20, 2023 Hon. Maryellen Noreika Rinvoq® (upadacitinib tablets) RE47,221
8,962,629
9,951,080
10,981,923
11,186,584
11,661,425
11,680,069
11,718,627
11,198,697
9,963,459
10,344,036
10,202,393
10,519,164
10,730,883
10,981,924
10,597,400
11,535,624
10,995,095
10,550,126
11,535,625
11,535,626
11,365,198
11,512,092
11,524,964
11,607,411
11,564,922
11,767,326
11,773,105
11,773,106
11,780,847
11,780,848
11,787,815 
11,795,175
9,879,018
Harmony Biosciences, LLC v. AET Pharma US, Inc., 23-1340 (D. Del.) Nov. 21, 2023 Hon. Maryellen Noreika Wakix® (pitolisant HCl tablets) 8,486,947
8,207,197
8,354,430
Bayer Pharma AG v. Aurobindo Pharma Ltd., 23-1372 (D. Del.) Dec. 1, 2023 Hon. Richard G. Andrews Xarelto® (rivaroxaban tablets) 10,828,310
AstraZeneca AB v. Sun Pharm. Industries Ltd., 23-1381 (D. Del.) Dec. 4, 2023 Hon. Richard G. Andrews Xigduo XR® (dapagliflozin / metformin HCl extended-release tablets) 6,515,117
AstraZeneca AB v. Sun Pharm. Industries Ltd., 23-1382 (D. Del.) Dec. 4, 2023 Hon. Richard G. Andrews Qtern® (dapagliflozin / saxagliptin HCl tablets) 6,515,117
AstraZeneca AB v. Sun Pharm. Industries Ltd., 23-1383 (D. Del.) Dec. 4, 2023 Hon. Richard G. Andrews Farxiga® (dapagliflozin tablets) 6,515,117
Bausch & Lomb, Inc. v. Slayback Pharma LLC, 23-22906 (D.N.J.) Dec. 5, 2023 Hon. Robert Kirsch Lumify® (brimonidine tartrate ophthalmic solution) 11,833,245
Merck Sharp & Dohme LLC v. Hetero USA Inc., 23-22954 (D.N.J.) Dec. 7, 2023 Hon. Claire C. Cecchi Isentress HD® (raltegravir tablets) 7,754,731
8,771,733
9,649,311
10,772,888
Par Pharm., Inc. v. Long Grove Pharms., LLC, 23-1412 (D. Del.) Dec. 8, 2023 Hon. Gregory B. Williams Vasostrict® (vasopressin injection) 9,993,520
11,207,372
MSN Labs. Private Ltd. v. Bioprojet Société Civile De Recherche, 23-1675 (E.D. Va.) Dec. 8, 2023 Hon. Claude M. Hilton Wakix® (pitolisant HCl tablets) 8,486,947
8,207,197
8,354,430
Harmony Biosciences, LLC v. MSN Pharms. Inc., 23-1420 (D. Del.) Dec. 11, 2023 Hon. Maryellen Noreika Wakix® (pitolisant HCl tablets) 8,486,947
8,207,197
8,354,430
Jazz Pharms. Research UK Ltd. v. Apotex Inc., 23-23141 (D.N.J.) Dec. 15, 2023 Hon. Michael E. Farbiarz Epidiolex® (cannabidiol oral solution) 11,701,330
11,766,411
Axsome Therapeutics, Inc. v. Teva Pharms., Inc., 23-23142 (D.N.J.) Dec. 15, 2023 Hon. Michael E. Farbiarz Auvelity® (dextromethorphan hydrobromide / bupropion HCl extended-release tablets) 11,717,518
11,730,706
11,752,144
Novartis Pharms. Corp. v. Novugen Oncology Sdn. Bhd., 23-1449 (D. Del.) Dec. 20, 2023 Hon. Gregory B. Williams Mekinist® (trametinib dimethyl sulfoxide tablets) 7,378,423
8,580,304
9,155,706
9,271,941
9,399,021
Axsome Malta Ltd. v. Unichem Labs. Ltd., 23-23255 (D.N.J.) Dec. 20, 2023 Hon. Madeline Cox Arleo Sunosi® (solriamfetol tablets) 11,753,368
11,771,666
11,771,667
11,779,554
11,793,776
Bayer Intellectual Property GmbH v. Umedica Labs. Pvt. Ltd., 23-1456 (D. Del.) Dec. 21, 2023 Hon. Richard G. Andrews Xarelto® (rivaroxaban tablets) 9,539,218
10,828,310
AstraZeneca AB v. ScieGen Pharms., Inc., 23-1457 (D. Del.) Dec. 21, 2023 Hon. Richard G. Andrews Brilinta® (ticagrelor tablets) 10,300,065
Novo Nordisk Inc. v. Sun Pharm. Indus. Ltd., 23-1459 (D. Del.) Dec. 21, 2023 Hon. Colm F. Connolly Wegovy® (semaglutide injection) 8,129,343
9,764,003
10,888,605
11,318,191
11,752,198
Azurity Pharms., Inc. v. Aurobindo Pharma Ltd., 23-23273 (D.N.J.) Dec. 21, 2023 Hon. Jamel K. Semper Firvanq® (vancomycin HCl oral solution) 10,493,028
10,688,046
10,959,946
10,959,947
10,959,948
10,959,949
11,638,692
Gilead Sciences, Inc. v. Cipla Ltd., 23-1480 (D. Del.) Dec. 29, 2023 Hon. Maryellen Noreika Biktarvy® (bictegravir sodium / emtricitabine / tenofovir alafenamide fumarate tablets) 9,708,342
10,385,067

Related Publications

Fourth Quarter
GENERICally Speaking: A Hatch-Waxman Litigation Bulletin
Oren Langer, Christopher Pinahs, Emily Tremblay, and Christine May
December 29, 2023
Corcept Therapeutics, Inc. v. Teva Pharms. USA, Inc.
GENERICally Speaking Hatch Waxman Bulletin
December 13, 2023
Acadia Pharms. Inc. v. Aurobindo Pharma Ltd.
GENERICally Speaking Hatch Waxman Bulletin
December 7, 2023
H. Lundbeck A/S v. Lupin Ltd.
GENERICally Speaking Hatch Waxman Bulletin
November 7, 2023
Eisai R&D Mgmt. Co., Ltd. v. Dr Reddy’s Labs., Inc.
GENERICally Speaking Hatch Waxman Bulletin
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