New ANDA Cases

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

Third Quarter

GENERICally Speaking

This New ANDA Cases 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).
Actelion Pharms. US, Inc. v. MSN Labs. Private Ltd., 23-0731 (D. Del.) 6-Jul-23 Hon. Gregory B. Williams Uptravi® (selexipag for injection) 8,791,122
9,284,280
Biogen Inc. v. Zydus Worldwide DMCC, 23-0732 (D. Del.) 6-Jul-23 Hon. Gregory B. Williams Vumerity® (diroximel fumarate delayed-release capsules) 8,669,281
9,090,558
10,080,733
Actelion Pharms. Ltd. v. Apotex Inc., 23-0734 (D. Del.) 6-Jul-23 Hon. Colm F. Connolly Opsumit® (macitentan tablets) 7,094,781
CMP Development, LLC v. Hetero USA, Inc., 23-0747 (D. Del.) 10-Jul-23 Hon. Maryellen Noreika CaroSpir® (spironolactone oral suspension) 9,757,394
10,493,083
10,624,906
10,660,907
10,888,570
11,389,461
11,395,828
11,491,166
AbbVie Inc. v. Lupin Ltd., 23-0750 (D. Del.) 10-Jul-23 Hon. Richard G. Andrews Orilissa® (elagolix sodium tablets) 11,542,239
Mitsubishi Tanabe Pharma Corp. v. Cipla USA Inc., 23-0759 (D. Del.) 12-Jul-23 Hon. Colm F. Connolly Radicava Ors® (edaravone oral suspension) 10,987,341
11,241,416
11,478,450
Gilead Sciences, Inc. v. Apotex Inc., 23-0774 (D. Del.) 14-Jul-23 Hon. Maryellen Noreika Genvoya® (elvitegravir / cobicistat / emtricitabine / tenofovir alafenamide tablets) 10,039,718
Gilead Sciences, Inc. v. Apotex Inc., 23-0775 (D. Del.) 14-Jul-23 Hon. Maryellen Noreika Genvoya® (elvitegravir / cobicistat / emtricitabine / tenofovir alafenamide tablets) 8,754,065
9,296,769
Alkermes Pharma Ireland Ltd. v. Slayback Pharma LLC, 23-3794 (D.N.J.) 14-Jul-23 Hon. Georgette Castner Anjeso® (meloxicam injection) 10,463,673
10,471,067
10,709,713
10,881,663
11,458,145
Azurity Pharms., Inc. v. Cosette Pharms., Inc., 23-3830 (D.N.J.) 18-Jul-23 Hon. Evelyn Padin Firvanq® (vancomycin HCl oral solution) 11,638,692
Oyster Point Pharma, Inc. v. Apotex, Inc., 23-3860 (D.N.J.) 19-Jul-23 Hon. Julien Xavier Neals Tyrvaya® (varenicline solution) 9,504,644
9,504,645
9,532,944
9,597,284
10,456,396
11,224,598
Allergan Holdings Unlimited Co. v. MSN Labs. Private Ltd., 23-0794 (D. Del.) 21-Jul-23 Hon. Richard G. Andrews Viberzi® (eluxadoline tablets) 11,484,527
Allergan Holdings Unlimited Co. v. Sun Pharm. Indus. Ltd., 23-0795 (D. Del.) 21-Jul-23 Hon. Richard G. Andrews Viberzi® (eluxadoline tablets) 11,484,527
Boehringer Ingelheim Pharms., Inc. v. Alvogen, Inc., 23-3911 (D.N.J.) 21-Jul-23 Hon. Kevin McNulty Spiriva® HandiHaler® (tiotropium bromide inhalation powder) 9,010,323
GW Research Ltd. v. Teva Pharms., Inc., 23-3914 (D.N.J.) 21-Jul-23 Hon. Michael Farbiarz Epidiolex® (cannabidiol oral solution) 11,633,369
Currax Pharms. LLC v. Ajanta Pharma Ltd., 23-3937 (D.N.J.) 24-Jul-23 Hon. Christine P. O’Hearn Silenor® (doxepin HCl tablets) 7,915,307
8,513,299
9,107,898
9,486,43
9,572,814
9,861,607
10,238,620
10,653,660
10,653,662
11,110,074
Janssen Pharmaceutica NV v. Natco Pharma Ltd., 23-3959 (D.N.J.) 25-Jul-23 Hon. Brian R. Martinotti Balversa® (erdafitinib tablets) 9,902,714
11,077,106
Supernus Pharms., Inc. v. Ascent Pharms. Inc., 23-4015 (D.N.J.) 26-Jul-23 Hon. Georgette Castner Trokendi XR® (topiramate extended-release capsules) 8,298,576
8,298,580
8,663,683
8,877,248
8,889,191
8,992,989
9,549,940
9,555,004
9,622,983
10,314,790
Novo Nordisk Inc. v. Lupin Ltd., 23-4027 (D.N.J.) 27-Jul-23 Hon. Georgette Castner Victoza® (liraglutide recombinant solution injection) 8,114,833
9,265,893
Novo Nordisk Inc. v. Lupin Ltd., 23-4031 (D.N.J.) 27-Jul-23 Hon. Susan D. Wigenton Saxenda® (liraglutide recombinant solution injection) 8,114,833
8,684,969
8,920,383
9,108,002
9,132,239
9,457,154
9,616,180
9,687,611
9,775,953
9,861,757
10,220,155
10,357,616
10,376,652
11,097,063
11,311,679
RE46,363
Astellas Pharma Inc. v. Lupin Ltd., 23-0819 (D. Del.) 28-Jul-23 Hon. Gregory B. Williams Myrbetriq® (mirabegron extended-release tablets) 11,707,451
Supernus Pharms., Inc. v. Ascent Pharms. Inc., 23-5720 (E.D.N.Y.) 28-Jul-23 Hon. Gary R. Brown Trokendi XR® (topiramate extended-release capsules) 8,298,576
8,298,580
8,663,683
8,877,248
8,889,191
8,992,989
9,549,940
9,555,004
9,622,983
10,314,790
Genentech, Inc. v. Sandoz, Inc., 23-4085 (D.N.J.) 31-Jul-23 Hon. Julien Xavier Neals Esbriet® (pirfenidone tablets) 10,188,637
Azurity Pharms., Inc. v. Zydus Worldwide DMCC, 23-0833 (D. Del.) Aug. 2, 2023 Hon. Maryellen Noreika Edarbi® (azilsartan medoxomil tablets) Edarbyclor® (azilsartan medoxomil / chlorthalidone tablets) 9,066,936
9,169,238
9,387,249
Azurity Pharms., Inc. v. Zydus Worldwide DMCC, 23-4152 (D.N.J.) Aug. 3, 2023 Hon. Robert Kirsch Edarbi® (azilsartan medoxomil tablets) Edarbyclor® (azilsartan medoxomil / chlorthalidone tablets) 9,066,936
9,169,238
9,387,249
Boehringer Ingelheim Pharms. Inc. v. Ajanta Pharma Ltd., 23-0847 (D. Del.) Aug. 4, 2023 Hon. Colm F. Connolly Glyxambi® (empagliflozin / linagliptin tablets) 8,551,957
9,949,998
10,258,637
11,090,323
Boehringer Ingelheim Pharms. Inc. v. Ajanta Pharma Ltd., 23-0848 (D. Del.) Aug. 4, 2023 Hon. Colm F. Connolly Jardiance® (empagliflozin tablets) 9,949,998
10,258,637
11,090,323
Boehringer Ingelheim Pharms. Inc. v. Ajanta Pharma Ltd., 23-0849 (D. Del.) Aug. 4, 2023 Hon. Colm F. Connolly Synjardy® (empagliflozin / metformin HCl tablets) 10,258,637
11,090,323
Par Pharm., Inc. v. Zydus Pharms. (USA) Inc., 23-0866 (D. Del.) Aug. 8, 2023 Hon. Richard G. Andrews Chantix® (varenicline tartrate tablets) 11,717,524
Vifor Fresenius Medical Care Renal Pharma Ltd. v. Aurobindo Pharma Ltd., 23-0877 (D. Del.) Aug. 10, 2023 Hon. Maryellen Noreika Velphoro® (sucroferric oxyhydroxide tablets) 9,561,251
10,624,855
10,682,376
10,695,367
10,925,896
10,925,897
10,933,090
11,013,761
11,013,762
11,234,938
11,446,252
Pfizer Inc. v. Dexcel Pharma Technologies Ltd., 23-0879 (D. Del.) Aug. 10, 2023 Hon. Gregory B. Williams Vyndamax® (tafamidis capsules) 7,214,695
7,214,696
9,770,441
AbbVie Inc. v. Alkem Labs. Ltd., 23-0881 (D. Del.) Aug. 10, 2023 Hon. Richard G. Andrews Orilissa® (elagolix sodium tablets) 11,542,239
AbbVie Inc. v. Zenara Pharma Private Ltd., 23-0892 (D. Del.) Aug. 11, 2023 Hon. Richard G. Andrews Orilissa® (elagolix sodium tablets) 11,542,239
Fresenius Kabi USA, LLC v. Amneal Pharms. LLC, 23-4343 (D.N.J.) Aug. 11, 2023 Hon. Claire C. Cecchi Diprivan® (propofol injection) 8,476,010
Allergan, Inc. v. Amneal Pharms. of New York, LLC, 23-6208 (E.D.N.Y.) Aug. 17, 2023 Hon. Gary R. Brown Lumigan® (bimatoprost ophthalmic solution) 7,851,504
8,278,353
8,299,118
8,309,605
8,338,479
8,524,777
8,586,630
8,772,338
8,933,120
8,933,127
9,155,716
9,241,918
Pfizer Inc. v. Cipla Ltd., 23-0909 (D. Del.) Aug. 18, 2023 Hon. Gregory B. Williams Vyndamax® (tafamidis capsules) 9,770,441
Theravance Biopharma R&D IP, LLC v. Eugia Pharma Specialties Ltd., 23-6667 (D.N.J.) Aug. 21, 2023 Hon. Karen M. Williams Yupelri® (revefenacin inhalation solution) 11,691,948
Pfizer Inc. v. Aurobindo Pharma Ltd., 23-0923 (D. Del.) Aug. 23, 2023 Hon. Gregory B. Williams Vyndaqel® (tafamidis meglumine capsules) 7,214,695
Pfizer Inc. v. Zenara Pharma Private Ltd., 23-0924 (D. Del.) Aug. 23, 2023 Hon. Gregory B. Williams Vyndamax® (tafamidis capsules) 9,770,441
Alkermes Pharma Ireland Ltd. v. Nanjing Delova Biotech Co., Ltd., 23-9763 (D.N.J.) Aug. 24, 2023 Hon. Georgette Castner Anjeso® (meloxicam injection) 9,974,746
10,709,713
10,881,663
11,458,145
Endo Par Innovation Co., LLC v. BPI Labs, LLC, 23-1953 (M.D. Fl.) Aug. 29, 2023 Hon. William F. Jung Adrenalin® (epinephrine injection) 9,119,876
9,295,657
Curia IP Holdings, LLC v. Salix Pharms., Ltd., 23-13764 (D.N.J.) Aug. 31, 2023 Hon. Karen M. Williams Xifaxan® (rifaximin tablets) 11,739,099
Amicus Therapeutics US, LLC v. Lupin Ltd., 23-0964 (D. Del.) Sept. 1, 2023 Hon. Christopher J. Burke Galafold® (migalastat capsules) 9,000,011
9,987,263
10,383,864
10,406,143
10,925,866
10,813,921
RE48,608
Par Pharm., Inc. v. Mankind Pharma Ltd., 23-0399 (E.D. Tex.) Sept. 1, 2023 Hon. Rodney Gilstrap Varenicline Tartrate 11,717,524
Par Pharm., Inc. v. Alkem Labs. Ltd., 23-0400 (E.D. Tex.) Sept. 1, 2023 Hon. Rodney Gilstrap Varenicline Tartrate 11,717,524
United Therapeutics Corp. v. Liquidia Technologies, Inc., 23-0975 (D. Del.) Sept. 5, 2023 Hon. Richard G. Andrews Tyvaso® (treprostinil inhalation solution) Tyvaso DPI® (treprostinil inhalation powder) Yutrepia® (treprostinil inhalation powder) 10,716,793
Azurity Pharms., Inc. v. Annora Pharma Private Ltd., 23-18420 (D.N.J.) Sept. 7, 2023 Hon. Christine P. O’Hearn Qbrelis® (lisinopril oral solution) 9,463,183
9,616,096
9,814,751
10,039,800
10,265,370
10,406,199
10,940,177
11,179,434
Celgene Corp. v. Teva Pharms., Inc., 23-1008 (D. Del.) Sept. 13, 2023 Hon. Richard G. Andrews Onureg® (azacitidine tablets) 8,846,628
11,571,436
Axsome Malta Ltd. v. Alkem Labs Ltd., 23-20354 (D.N.J.) Sept. 13, 2023 Hon. Madeline Cox Arleo Sunosi® (solriamfetol tablets) 8,440,715
8,877,806
9,604,917
10,351,517
10,195,151
10,512,609
11,439,597
10,912,754
10,959,976
11,160,779
10,940,133
11,560,354
11,648,232
Heron Therapeutics, Inc. v. Mylan Pharms. Inc., 23-1015 (D. Del.) Sept. 15, 2023 Hon. William C. Bryson Civanti® (aprepitant injection) 9,561,229
9,808,465
9,974,742
9,974,793
9,974,794
10,500,208
10,624,850
10,953,018
11,173,118
Celgene Corp. v. Natco Pharma Ltd., 23-1019 (D. Del.) Sept. 18, 2023 Hon. Richard G. Andrews Onureg® (azacitidine tablets) 8,846,628
11,571,436
Fresenius Kabi USA, LLC v. Meitheal Pharms., Inc., 23-1050 (D. Del.) Sept. 26, 2023 Hon. Colm F. Connolly Diprivan® (propofol injectable emulsion) 8,476,010
Orphalan SA v. Novitium Pharma LLC, 23-1079 (D. Del.) Sept. 29, 2023 Hon. Gregory B. Williams Cuvrior® (triethylenetetramine tetrachloride tablets) 10,988,436
11,072,577
Azurity Pharms., Inc. v. Teva Pharms., Inc., 23-1080 (D. Del.) Sept. 29, 2023 Hon. Maryellen Noreika Edarbyclor® (azilsartan medoxomil / chlorthalidone tablets) 9,066,936
9,169,238
9,387,249

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