Federal Hatch-Waxman ANDA Cases Q1 2026 Chart

April 21, 2026

New ANDA Cases - First Quarter 2026

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Federal district court cases that are filed pursuant to the Hatch-Waxman Act and Post Grant Proceedings at the PTAB involving Orange Book-listed patents

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). |
| AbbVie Inc. v. Hetero USA Inc., 26-0114 (D.N.J.) | Jan. 7, 2026 | Hon. Zahid N. Quraishi | Qulitpa®
(atogepant tablets) | 12,090,148
12,350,259
12,383,545
12,465,598 |
| AbbVie Inc. v. MSN Pharms. Inc., 26-0115 (D.N.J.) | Jan. 7, 2026 | Hon. Zahid N. Quraishi | Qulitpa®
(atogepant tablets) | 12,090,148
12,350,259
12,383,545
12,465,598 |
| Abraxis BioScience, LLC v. Qilu Pharm. (Hainan) Co., Ltd., 26-0140 (D.N.J.) | Jan. 8, 2026 | Hon. Karen M. Williams | Abraxane®
(paclitaxel protein-bound
particles for injectable suspension) | 7,758,891
8,034,375
8,268,348
9,101,543
9,393,318
9,511,046
9,597,409 |
| Aragon Pharms., Inc. v. Hetero Labs Ltd. Unit V, 26-0168 (D.N.J.) | Jan. 9, 2026 | Hon. Stanley R. Chesler | Erleada®
(apalutamide tablets) | 12,303,493
12,303,497 |
| Oyster Point Pharma, Inc. v. Lupin Ltd., 26-0353 (D.N.J.) | Jan. 12, 2026 | Hon. Edward S. Kiel | Tyrvaya®
(varenicline solution) | 9,504,644
9,504,645
9,532,944
9,597,284
10,456,396
11,224,598
11,903,941
11,903,943
11,911,380 |
| Takeda Pharms. U.S.A., Inc. v. Macleods Pharms. Ltd., 26-0042 (D. Del.) | Jan. 14, 2026 | Hon. Jennifer L. Hall | Colcrys®
(colchicine tablets) | 7,906,519
7,935,731
8,093,298
7,964,648
8,093,297
7,619,004
7,601,758
7,820,681
7,915,269
7,964,647
7,981,938
8,093,296
8,097,655
8,415,395
8,415,396
8,440,721
8,440,722 |
| AbbVie Inc. v. Micro Labs Ltd., 26-0518 (D.N.J.) | Jan. 15, 2026 | Hon. Zahid N. Quraishi | Qulipta®
(atogepant tablets) | 12,090,148
12,350,259
12,383,545
12,465,598 |
| Incyte Corp. v. Encube Ethicals Pvt. Ltd., 26-0539 (D.N.J.) | Jan. 16, 2026 | 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
12,226,419 |
| ChemoCentryx, Inc. v. Zydus Pharms. (USA) Inc., 26-0556 (D.N.J.) | Jan. 16, 2026 | Hon. Jamel K. Semper | Tavneos®
(avacopan capsules) | 11,951,214
11,603,356 |
| Tanabe Pharma Corp. v. Azurity Pharms., Inc., 26-0559 (D.N.J.) | Jan. 16, 2026 | Hon. Claire C. Cecchi | Radicava ORS®
(edaravone injection) | 10,987,341
11,241,416
11,478,450
11,826,352
11,957,660
12,194,025
12,285,409
12,310,946
12,478,611 |
| Sun Pharm. Indus., Inc. v. Biofrontera Bioscience GmbH, PGR2026-00021 (PTAB) | Jan. 16, 2026 | N/A | Ameluz®
(aminolevulinic acid HCl topical gel) | 12,280,146 |
| Tanabe Pharma Corp. v. Azurity Pharms., Inc., 26-0069 (D. Del.) | Jan. 21, 2026 | Hon. Jennifer L. Hall | Radicava ORS®
(edaravone injection) | 10,987,341
11,241,416
11,478,450
11,826,352
11,957,660
12,194,025
12,285,409
12,310,946
12,478,611 |
| Vertex Pharms. Inc. v. Lupin Ltd., 26-0084 (D. Del.) | Jan. 23, 2026 | Hon. Stephanos Bibas | Kalydeco®
(ivacaftor tablets) | 12,458,635 |
| Gilead Sciences, Inc. v. Macleods Pharms. Ltd., 26-0094 (D. Del.) | Jan. 28, 2026 | Hon. Maryellen Noreika | Vemlidy®
(tenofovir alafenamide tablets) | 8,754,065
9,296,769 |
| Grünenthal GmbH v. Hikma Pharms. USA Inc., 26-0999 (D.N.J.) | Feb. 2, 2026 | Hon. Esther Salas | Nucynta® ER
(tapentadol extended-release tablets) | 8,536,130
11,344,512 |
| BioMarin Pharm. Inc. v. Zydus Lifesciences Ltd., 26-1005 (D.N.J.) | Feb. 2, 2026 | Hon. Renee Marie Bumb | Voxzogo®
(vosoritide for injection) | 12,233,106 |
| Saptalis Pharms., LLC v. MSN Pharms., Inc., 26-1084 (D.N.J.) | Feb. 3, 2026 | Hon. Evelyn Padin | Likmez®
(metronidazole oral suspension) | 11,541,035
12,257,236 |
| Novartis Pharms. Corp. v. Apotex Inc., 26-0141 (D. Del.) | Feb. 6, 2026 | Hon. Colm F. Connolly | Tafinlar®
(dabrafenib) capsules) | 7,994,185
8,415,345
8,703,781
9,233,956 |
| Chemocentryx, Inc. v. Annora Pharma Private Ltd., 26-1279 (D.N.J.) | Feb. 9, 2026 | Hon. Jamel K. Semper | Tavneos®
(avacopan capsules) | 11,951,214
11,603,356 |
| Gilead Sciences, Inc. v. Cipla Ltd., 26-0149 (D. Del.) | Feb. 10, 2026 | Hon. Maryellen Noreika | Descovy®
(tenofovir alafenamide / emtricitabine tablets) | 8,754,065
9,296,769
9,777,028
8,664,386
9,029,534
9,346,841
9,676,804 |
| GlaxoSmithKline LLC v. Natco Pharma Ltd., 26-0168 (D. Del.) | Feb. 13, 2026 | Hon. Colm F. Connolly | Zejula®
(niraparib tablets) | 11,091,459
11,673,877 |
| Axsome Malta Ltd. v. Aurobindo Pharma USA, Inc., 26-1580 (D.N.J.) | Feb. 18, 2026 | Hon. Stanley R. Chesler | Sunosi®
(solriamfetol tablets) | 12,384,743 |
| Takeda Pharm. Co. Ltd. v. Qilu Pharm. (Hainan) Co., Ltd., 26-1633 (D.N.J.) | Feb. 18, 2026 | Hon. Esther Salas | Livtencity®
(maribavir tablets) | 11,684,632
12,213,989
12,295,940
12,433,907
12,447,169
12,447,170 |
| Otsuka Pharm. Co., Ltd. v. Zenara Pharma Private Ltd., 26-0181 (D. Del.) | Feb. 19, 2026 | Hon. Stephanos Bibas | Jynarque®
(tolvaptan tablets) | 8,501,730
10,905,694
8,273,735 |
| PH Health Ltd. v. ARS Pharms. Operations, Inc., 26-0184 (D. Del.) | Feb. 19, 2026 | Hon. Maryellen Noreika | Neffy®
(epinephrine nasal spray) | 9,119,876
9,295,657
12,280,024
10,130,592 |
| Kudos Pharms. Ltd. v. Natco Pharma Ltd., 26-1711 (D.N.J.) | Feb. 20, 2026 | Hon. Robert Kirsch | Zejula®
(niraparib) tablets) | 8,859,562 |
| Novo Nordisk Inc. v. Apotex Inc., 26-1730 (D.N.J.) | Feb. 20, 2026 | Hon. Renee Marie Bumb | Rybelsus®
(semaglutide tablets) | 9,278,123
10,278,923
11,382,957
11,833,248
12,396,953
12,514,822 |
| Tanabe Pharma Corp. v. Cipla USA, Inc., 26-1734 (D.N.J.) | Feb. 20, 2026 | Hon. Claire C. Cecchi | Radicava ORS®
(edaravone oral suspension) | 12,478,611 |
| Jazz Pharms. Ireland Ltd. v. Tris Pharma, Inc., 26-1739 (D.N.J.) | Feb. 20, 2026 | Hon. Stanley R. Chesler | Xyrem®
(sodium oxybate oral solution) | 8,772,306
9,050,302
9,486,426
10,213,400
10,864,181
11,253,494
11,986,446 |
| Jazz Pharms. Ireland Ltd. v. Tris Pharma, Inc., 26-1740 (D.N.J.) | Feb. 20, 2026 | Hon. Stanley R. Chesler | Xywav®
(calcium, magnesium, potassium,
and sodium oxybates oral solution) | 8,591,922
8,772,306
8,901,173
9,050,302
9,132,107
9,486,426
10,195,168
10,213,400
10,675,258
10,864,181
11,253,494
11,426,373
11,554,102
11,986,446
12,138,233 |
| Takeda Pharm. Co. Ltd. v. Annora Pharma Private Ltd., 26-1780 (D.N.J.) | Feb. 23, 2026 | Hon. Esther Salas | Livtencity®
(maribavir tablets) | 11,684,632
12,213,989
12,295,940
12,433,907
12,447,169
12,447,170 |
| Calliditas Therapeutics AB v. Qilu Pharm. Co., Ltd., 26-0197 (D. Del.) | Feb. 24, 2026 | Hon. Jennifer Choe-Groves | Tarpeyo®
(budesonide delayed-release capsules) | 11,896,719
12,171,882
12,171,883
12,311,057 |
| Journey Medical Corp. v. Lupin Ltd., 26-0202 (D. Del.) | Feb. 25, 2026 | Hon. Colm F. Connolly | Emrosi™
(minocycline HCl extended-release capsules) | 10,905,664
11,191,740
11,364,212 |
| BeOne Medicines USA, Inc. v. Zydus Pharms. (USA) Inc., 26-2010 (D.N.J.) | Feb. 25, 2026 | Hon. Michael E. Farbiarz | Brukinsa®
(zanubrutinib tablets) | 10,927,117
11,591,340
11,851,437
11,884,674
11,970,500
11,701,357
11,786,531
11,896,596
11,911,386
12,233,069 |
| ARS Pharms. Operations, Inc. v. Lupin Inc., 26-2036 (D.N.J.) | Feb. 26, 2026 | Hon. Julien Xavier Neals | neffy®
(epinephrine nasal spray) | 10,576,156
10,682,414
11,173,209
11,191,838
11,717,571
11,744,895
11,918,655
12,324,838 |
| Takeda Pharm. Co. Ltd. v. Sun Pharm. Indus. Ltd., 26-2051 (D.N.J.) | Feb. 26, 2026 | Hon. Esther Salas | Livtencity®
(maribavir tablets) | 11,684,632
12,213,989
12,295,940
12,433,907
12,447,169
12,447,170 |
| Xeris Pharms., Inc. v. Somerset Therapeutics, LLC, 26-2044 (D.N.J.) | Feb. 26, 2026 | Hon. Julien Xavier Neals | Recorlev®
(levoketoconazole tablets) | 11,020,393
11,278,547
11,903,940
12,377,096 |
| Otsuka Pharm. Co., Ltd. v. Sandoz Inc., 26-0232 (D. Del.) | Mar. 5, 2026 | Hon. Stephanos Bibas | Jynarque®
(tolvaptan tablets) | 10,905,694
8,273,735 |
| Esperion Therapeutics, Inc. v. Renata Ltd., 26-2326 (D.N.J.) | Mar. 5, 2026 | Hon. Julien Xavier Neals | Nexlizet®
(bempedoic acid / ezetimibe tablets) | 11,760,714
11,613,511
11,926,584
11,744,816
12,398,087
12,404,227
10,912,751 |
| Incyte Corp. v. Alkem Labs. Ltd., 26-2338 (D.N.J.) | Mar. 5, 2026 | Hon. Christine P. O’Hearn | Jakafi®
(ruxolitinib tablets) | 8,722,693
8,822,481
8,829,013 |
| GlaxoSmithKline Intellectual Property Development Ltd. v. Transpire Bio Inc., 26-21512 (S.D. Fla.) | Mar. 6, 2026 | Hon. Roy K. Altman | Trelegy Ellipta®
(fluticasone furoate / umeclidinium /
vilanterol inhalation powder) | 8,534,281
8,746,242
9,750,726
11,090,294
12,396,986 |
| Neurelis, Inc. v. Lupin Inc., 26-0258 (D. Del.) | Mar. 11, 2026 | Hon. Maryellen Noreika | Valtoco®
(diazepam nasal spray) | 12,521,400 |
| Neurelis, Inc. v. Amneal Pharms. LLC, 26-0261 (D. Del.) | Mar. 11, 2026 | Hon. Maryellen Noreika | Valtoco®
(diazepam nasal spray) | 11,241,414
11,793,786
12,268,664
12,324,852
12,337,061
12,521,400 |
| Aurobindo Pharma Ltd. v. Azurity Pharms. Inc., 26-0265 (D. Del.) | Mar. 12, 2026 | Hon. Maryellen Noreika | Horizant®
(gabapentin enacarbil
extended-release tablets) | 8,795,725 |
| Novartis Pharms. Corp. v. Cipla USA Inc., 26-0272 (D. Del.) | Mar. 13, 2026 | Hon. Gregory B. Williams | Leqvio®
(inclisiran injection) | 10,125,369
10,851,377
12,460,206 |
| Jazz Pharms., Inc. v. Almaject, Inc., 26-2629 (D.N.J.) | Mar. 13, 2026 | Hon. Stanley R. Chesler | Defitelio®
(defibrotide sodium injection) | 12,529,052
12,534,722 |
| CMP Development LLC v. MSN Pharms., Inc., 26-2653 (D.N.J.) | Mar. 16, 2026 | Hon. Madeline Cox Arleo | Tadliq®
(tadalafil oral suspension) | 11,382,917
11,666,576
11,975,006
12,186,322 |
| Eli Lilly & Co. v. Qilu Pharm. Co., Ltd., 26-2866 (D.N.J.) | Mar. 19, 2026 | Hon. Evelyn Padin | Reyvow®
(lasmiditan tablets) | 7,423,050 |
| Xeris Pharms., Inc. v. Sandoz Inc., 26-2929 (D.N.J.) | Mar. 20, 2026 | Hon. Julien Xavier Neals | Recorlev®
(levoketoconazole tablets) | 11,020,393
11,278,547
11,903,940
12,377,096 |
| Veloxis Pharms., Inc. v. Glenmark Pharms. Inc., 26-0305 (D. Del.) | Mar. 20, 2026 | Hon. Maryellen Noreika | Envarsus XR®
(tacrolimus extended-release tablets) | 12,403,095 |
| Vertex Pharms. Inc. v. MSN Pharms. Inc., 26-0306 (D. Del.) | Mar. 20, 2026 | Hon. Colm F. Connolly | Kalydeco®
(ivacaftor tablets) | 10,646,481
11,564,916
12,458,635 |
| Adverio Pharma GmbH v. Sandoz Inc., 26-0321 (D. Del.) | Mar. 23, 2026 | Hon. Gregory B. Williams | Adempas®
(riociguat tablets) | 12,503,469 |
| Shanghai Aucta Pharms. Co. Ltd. v. Zydus Pharms. (USA) Inc., 26-2954 (D.N.J.) | Mar. 23, 2026 | Hon. Edward S. Kiel | Motpoly XR™
(lacosamide extended-release capsules) | 11,337,943
11,883,374
12,042,474 |
| Onyx Therapeutics, Inc. v. Hetero USA Inc., 26-0324 (D. Del.) | Mar. 24, 2026 | Hon. Gregory B. Williams | Kyprolis®
(carfilzomib injection) | 7,737,112 |
| Janssen Pharms., Inc. v. Eugia Pharma Specialties Ltd., 26-3197 (D.N.J.) | Mar. 25, 2026 | Hon. Claire C. Cecchi | Invega Sustenna®
(paliperidone palmitate
extended-release injectable suspension) | 9,439,906 |
| Boehringer Ingelheim Pharms. Inc. v. Ipca Labs. Ltd., 26-0336 (D. Del.) | Mar. 26, 2026 | Hon. Colm F. Connolly | Tradjenta®
(linagliptin tablets) | 9,486,526
10,034,877
11,033,552 |
| Gilead Sciences, Inc. v. SABA Ilac Sanayi ve Ticaret A.S., 26-3282 (D.N.J.) | Mar. 27, 2026 | Hon. Michael E. Farbiarz | Vemlidy®
(tenofovir alafenamide tablets) | 8,754,065
9,296,769 |
[View source.]

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.
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