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 |
