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). |
| Ultragenyx Pharm. Inc. v. Somerset Therapeutics LLC, 26-3509 (D.N.J.) | Apr. 1, 2026 | Hon. Esther Salas | Dojolvi® (triheptanoin oral liquid) | 8,697,748 12,551,461 |
| Abraxis Bioscience, LLC v. Dr. Reddy’s Labs., Inc., 26-3559 (D.N.J.) | Apr. 2, 2026 | Hon. Karen M. Williams | Abraxane® (paclitaxel injectable suspension) | 8,034,375 9,393,318 9,511,046 9,597,409 |
| Supernus Pharms., Inc. v. Zydus Lifesciences Global FZE, 26-3543 (D.N.J.) | Apr. 2, 2026 | Hon. Michael E. Farbiarz | Qelbree® (viloxazine extended-release capsules) | 11,324,753 11,458,143 12,121,523 |
| Ultragenyx Pharm. Inc. v. Navinta LLC, 26-3585 (D.N.J.) | Apr. 3, 2026 | Hon. Esther Salas | Dojolvi® (triheptanoin oral liquid) | 12,551,461 |
| Boehringer Ingelheim Pharms. Inc. v. Ridhisidhi PLLC, 26-0372 (D. Del.) | Apr. 3, 2026 | Hon. Colm F. Connolly | Jardiance® (empagliflozin tablets) | 9,949,998 10,258,637 11,090,323 11,833,166 12,433,906 |
| Rayner Surgical Inc. v. Amneal Pharms. of NY, LLC, 26-3629 (D.N.J.) | Apr. 6, 2026 | Hon. Georgette Castner | Omidria® (phenylephrine and ketorolac injection) | 9,066,856 9,486,406 9,855,246 |
| Neurelis, Inc. v. Padagis LLC, 26-0401 (D. Del.) | Apr. 8, 2026 | Hon. Maryellen Noreika | Valtoco® (diazepam nasal spray) | 12,521,400 |
| Azurity Pharms., Inc. v. Appco Pharma LLC, 26-0402 (D. Del.) | Apr. 8, 2026 | Hon. Gregory B. Williams | Zonisade® (zonisamide oral suspension) | 11,478,456 11,529,333 12,491,179 |
| ARS Pharms. Operations, Inc. v. Cipla Ltd., 26-3796 (D.N.J.) | Apr. 10, 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 |
| Bausch Health Ireland Ltd. v. Zydus Pharms. (USA) Inc., 26-3803 (D.N.J.) | Apr. 10, 2026 | Hon. Madeline Cox Arleo | Cabtreo® (clindamycin phosphate / adapalene / benzoyl peroxide topical gel) | 11,389,467 12,128,059 12,133,859 12,138,278 |
| Ingenus Pharms., LLC v. Mylan Pharms., Inc., 26-0039 (N.D.W.V.) | Apr. 10, 2026 | Hon. Thomas S. Kleeh | Cyclophosphamide Injection | 10,993,952 12,329,767 |
| Shionogi Inc. v. Lupin Ltd., 26-3893 (D.N.J.) | Apr. 13, 2026 | Hon. Claire C. Cecchi | Radicava ORS® (edaravone oral suspension) | 12,478,611 12,527,769 |
| UCB Inc. v. Rubicon Research Ltd., 26-0427 (D. Del.) | Apr. 14, 2026 | Hon. Jennifer L. Hall | Nayzilam® (midazolam nasal spray) | 8,217,033 8,809,322 9,289,432 9,687,495 |
| Pfizer Inc. v. Micro Labs Ltd., 26-0439 (D. Del.) | Apr. 16, 2026 | Hon. Jennifer L. Hall | Cibinqo® (abrocitinib tablets) | 9,035,074 9,545,405 9,549,929 |
| Pfizer Inc. v. Changzhou Pharm. Factory, 26-0440 (D. Del.) | Apr. 16, 2026 | Hon. Jennifer L. Hall | Cibinqo® (abrocitinib tablets) | 9,035,074 9,545,405 9,549,929 |
| Pfizer Inc. v. Biocon Ltd., 26-0441 (D. Del.) | Apr. 16, 2026 | Hon. Jennifer L. Hall | Cibinqo® (abrocitinib tablets) | 9,035,074 |
| Astellas Pharma Inc. v. Dr. Reddy’s Labs., Inc., 26-4101 (D.N.J.) | Apr. 17, 2026 | Hon. Michael A. Shipp | Xtandi® (enzalutamide tablets) | 11,839,689 12,161,628 12,502,357 12,447,128 |
| Takeda Pharm. Co. Ltd. v. Qilu Pharm. (Hainan) Co., Ltd., 26-4121 (D.N.J.) | Apr. 17, 2026 | Hon. Esther Salas | Livtencity® (maribavir tablets) | 12,527,771 |
| Harmony Biosciences Management, Inc. v. AET Pharma US, 26-0453 (D. Del.) | Apr. 20, 2026 | Hon. Jennifer L. Hall | Wakix® (pitolisant HCl tablets) | 11,623,920 |
| Apotex Inc. v. Soleno Therapeutics, Inc., PGR2026-00034 (PTAB) | Apr. 21, 2026 | N/A | Vykat XR® (diazoxide choline extended-release tablets) | 12,419,895 |
| Orphalan SA v. Novitium Pharma LLC, 26-0463 (D. Del.) | Apr. 22, 2026 | Hon. Gregory B. Williams | Cuvrior® (triethylenetetramine tetrachloride tablets) | 10,988,436 11,072,577 12,358,861 12,358,862 |
| Sun Pharm. Indus., Ltd. v. Solaris Pharma Corp., 26-4286 (D.N.J.) | Apr. 22, 2026 | Hon. Evelyn Padin | BromSite® (bromfenac ophthalmic solution) | RE50,218 |
| Veloxis Pharms., Inc. v. Zydus Pharms. (USA) Inc., 26-0467 (D. Del.) | Apr. 23, 2026 | Hon. Maryellen Noreika | Envarsus XR® (tacrolimus extended-release tablets) | 8,664,239 8,685,998 9,549,918 10,166,190 10,864,199 11,110,081 11,123,331 11,419,823 12,083,103 12,403,095 |
| Bayer Intellectual Property GmbH v. Rosemont Pharms. Ltd., 26-0471 (D. Del.) | Apr. 23, 2026 | Hon. Richard G. Andrews | Xarelto® (rivaroxaban tablets) | 9,539,218 |
| Indivior Inc. v. Sparsha Pharma USA, Inc., 26-2633 (S.D. Cal.) | Apr. 24, 2026 | Hon. Benjamin J. Cheeks | Suboxone® (buprenorphine HCl / naloxone HCl sublingual film) | 9,687,454 11,135,216 |
| Opus Genetics, Inc. v. Sandoz Inc., 26-4811 (D.N.J.) | Apr. 29, 2026 | Hon. Zahid N. Quraishi | Ryzumvi® (phentolamine ophthalmic solution) | 12,576,066 12,576,067 |
| Otsuka Pharm. Co., Ltd. v. MSN Pharms. Inc., 26-0496 (D. Del.) | Apr. 30, 2026 | Hon. Stephanos Bibas | Jynarque® (tolvaptan tablets) | 8,501,730 10,905,694 8,273,735 |
| Takeda Pharm. Co. Ltd. v. Sun Pharm. Indus. Ltd., 26-4939 (D.N.J.) | 1-May-26 | Hon. Esther Salas | Livtencity® (maribavir tablets) | 12,527,771 |
| Pharmacosmos Holding A/S v. Mylan Labs. Ltd., 26-4946 (D.N.J.) | 1-May-26 | Hon. Michael E. Farbiarz | Injectafer® (ferric carboxymaltose injection) | 12,295,934 12,303,486 |
| Pharmacosmos Holding A/S v. Sandoz Inc., 26-4948 (D.N.J.) | 1-May-26 | Hon. Michael E. Farbiarz | Injectafer® (ferric carboxymaltose injection) | 12,295,934 2,303,486 |
| Pharmacosmos Holding A/S v. Dr. Reddy’s Labs., Ltd., 26-4950 (D.N.J.) | 1-May-26 | Hon. Michael E. Farbiarz | Injectafer® (ferric carboxymaltose injection) | 12,295,934 2,303,486 |
| Bow River LLC v. Zydus Lifesciences Global FZE, 26-0535 (D. Del.) | 7-May-26 | Hon. Jennifer Choe-Groves | Vitrakvi® (larotrectinib sulfate capsules) | 11,337,967 11,974,998 |
| Salix Pharms., Inc. v. Hetero USA, Inc., 26-5142 (D.N.J.) | 7-May-26 | Hon. John F. Murphy | Xifaxan® (rifaximin tablets) | 11,779,571 11,564,912 8,193,196 |
| Array Biopharma Inc. v. Zydus Lifesciences Ltd., 26-0541 (D. Del.) | 8-May-26 | Hon. Jennifer Choe-Groves | Vitrakvi® (larotrectinib sulfate capsules) | 9,782,414 10,172,861 10,285,993 10,799,505 10,813,936 |
| Bow River LLC v. Zydus Lifesciences Global FZE, 26-5216 (D.N.J.) | 8-May-26 | Hon. Susan D. Wigenton | Vitrakvi® (larotrectinib sulfate capsules) | 11,337,967 11,974,998 |
| Vanda Pharms. Inc. v. Aurobindo Pharma Ltd., 26-0562 (D. Del.) | 14-May-26 | Hon. Jennifer L. Hall | Hetlioz® (tasimelteon capsules) | 11,285,129 11,850,229 11,918,556 10,610,510 10,980,770 10,071,977 11,566,011 11,760,740 12,049,457 |
| Apotex Inc. v. Agios Pharms., Inc., IPR2026-00351 (PTAB) | 18-May-26 | N/A | Aqvesme® (mitapivat sulfate tablets) Pyrukynd® (mitapivat sulfate tablets) | 11,878,049 |
| Biogen MA Inc. v. Somerset Therapeutics, LLC, 26-0580 (D. Del.) | 20-May-26 | Hon. Colm F. Connolly | Spinraza® (nusinersen intrathecal injection) | 9,926,559 10,436,802 12,013,403 |
| Agios Pharms., Inc. v. Annora Pharma Private Ltd., 26-0603 (D. Del.) | 26-May-26 | Hon. Colm F. Connolly | Pyrukynd® (mitapivat tablets) | 11,234,976 11,254,652 11,878,049 |
| Shionogi Inc. v. Lupin Ltd., 26-6218 (D.N.J.) | 28-May-26 | Hon. Jennifer Choe-Groves | Radicava ORS® (edaravone oral suspension) | 12,569,469 |
| Pfizer Inc. v. Alkem Labs. Ltd., 26-0623 (D. Del.) | 29-May-26 | Hon. Jennifer L. Hall | Inlyta® (axitinib) tablets) | 8,791,140 |
| Incyte Corp. v. Padagis Israel Pharms. Ltd., 26-6262 (D.N.J.) | 29-May-26 | Hon. Madeline Cox Arleo | Opzelura® (ruxolitinib cream) | 12,544,381 12,564,593 |
| Novo Nordisk Inc. v. Apotex Inc., 26-6553 (D.N.J.) | 4-Jun-26 | Hon. Renee Marie Bumb | Wegovy® (semaglutide tablets) | 9,278,123 10,278,923 11,033,499 11,382,957 11,833,248 12,239,739 12,396,953 |
| Genentech, Inc. v. Zenara Pharma Private Ltd., 26-6555 (D.N.J.) | 4-Jun-26 | Hon. Jennifer Choe-Groves | Evrysdi® (risdiplam tablets) | 9,586,955 9,969,754 11,534,444 11,827,646 12,122,789 12,350,273 |
| Incyte Corp. v. Zydus Lifesciences Ltd., 26-6562 (D.N.J.) | 4-Jun-26 | Hon. Madeline Cox Arleo | Opzelura® (ruxolitinib cream) | 10,758,543 10,869,870 11,219,624 11,571,425 11,590,136 12,226,419 12,544,381 12,564,593 |
| Xeris Pharms., Inc. v. Novitium Pharma, LLC, 26-6568 (D.N.J.) | 4-Jun-26 | Hon. Julien Xavier Neals | Recorlev® (levoketoconazole tablets) | 11,020,393 11,278,547 11,903,940 12,377,096 |
| Teva Neuroscience, Inc. v. Alkem Labs. Ltd., 26-6612 (D.N.J.) | 5-Jun-26 | Hon. Evelyn Padin | Austedo® XR (deutetrabenazine extended-release tablets) | 9,550,780 10,959,996 11,179,386 11,311,488 11,357,772 11,446,291 11,564,917 11,648,244 11,813,232 12,016,858 12,589,075 12,599,598 |
| Shionogi Inc. v. Zydus Pharms. (USA) Inc., 26-6619 (D.N.J.) | 5-Jun-26 | Hon. Jennifer Choe-Groves | Radicava ORS® (edaravone oral suspension) | 12,478,611 12,527,769 12,569,469 |
| Zydus Lifesciences Ltd. v. Biomarin Pharm. Inc., PGR2026-00055 (PTAB) | 5-Jun-26 | N/A | Voxzogo® (vosoritide injection) | 12,233,106 |
| AbbVie Inc. v. MSN Pharms. Inc., 26-0680 (D. Del.) | 10-Jun-26 | Hon. Maryellen Noreika | Rinvoq® LQ (upadacitinib oral solution) | 11,186,584 12,365,689 |
| Incyte Corp. v. Sun Pharma Canada Inc., 26-6905 (D.N.J.) | 10-Jun-26 | Hon. Madeline Cox Arleo | Opzelura® (ruxolitinib cream) | 12,564,593 |
| AbbVie Inc. v. Annora Pharma Private Ltd., 26-0688 (D. Del.) | 11-Jun-26 | Hon. Maryellen Noreika | Rinvoq® LQ (upadacitinib oral solution) | 11,186,584 12,365,689 |
| Eli Lilly and Co. v. Cipla Ltd., 26-0691 (D. Del.) | 12-Jun-26 | Hon. Colm F. Connolly | Verzenio® (abemaciclib tablets) | 7,855,211 |
| Shionogi Inc. v. Sandoz Inc., 26-7063 (D.N.J.) | 12-Jun-26 | Hon. Jennifer Choe-Groves | Radicava ORS® (edaravone oral suspension) | 12,478,611 12,527,769 12,569,469 |
| Hetero USA, Inc. v. Merck Sharp and Dohme LLC, 26-700 (D. Del.) | 16-Jun-26 | Hon. Gregory B. Williams | Belsomra® (suvorexant tablets) | 10,098,892 11,980,623 |
| GlaxoSmithKline Intellectual Property Development Ltd. v. Transpire Bio Inc., 26-61712 (S.D. Fla.) | 16-Jun-26 | Hon. Melissa Damian | Trelegy Ellipta (fluticasone furoate / umeclidinium / vilanterol inhalation powder) | 8,534,281 8,746,242 9,750,726 12,396,986 |
| AbbVie Inc. v. Dr. Reddy’s Labs., Inc., 26-0705 (D. Del.) | 17-Jun-26 | Hon. Maryellen Noreika | Rinvoq® LQ (upadacitinib oral solution) | 11,186,584 12,365,689 |
| Alkermes, Inc. v. Apotex Corp., 26-7358 (D.N.J.) | 18-Jun-26 | Hon. Karen M Williams | Lybalvi® (olanzapine / samidorphan tablets) | 8,778,960 9,119,848 9,126,977 9,517,235 10,300,054 10,716,785 11,185,541 11,241,425 11,351,166 11,793,805 12,194,035 |
| Rayner Surgical Inc. v. Mankind Pharma Ltd., 26-7370 (D.N.J.) | 18-Jun-26 | Hon. Georgette Castner | Omidria® (phenylephrine and ketorolac injection) | 9,066,856 9,486,406 9,855,246 |
| Biogen MA Inc. v. Somerset Therapeutics, LLC, 26-0735 (D. Del.) | 22-Jun-26 | Hon. Colm F. Connolly | Spinraza® (nusinersen intrathecal injection) | 9,926,559 10,436,802 12,013,403 |
| Biogen MA Inc. v. Cipla Ltd., 26-0736 (D. Del.) | 22-Jun-26 | Hon. Colm F. Connolly | Spinraza® (nusinersen intrathecal injection) | 9,926,559 10,436,802 12,013,403 |
| Gilead Sciences, Inc. v. Cipla Ltd., 26-0756 (D. Del.) | 26-Jun-26 | Hon. Maryellen Noreika | Descovy® (tenofovir alafenamide / emtricitabine tablets) | 12,629,338 12,648,911 12,661,323 |
| Aragon Pharms., Inc. v. MSN Pharms. Inc., 26-7798 (D.N.J.) | 26-Jun-26 | Hon. Michael E. Farbiarz | Erleada® (apalutamide tablets) | 9,481,663 11,963,952 12,303,493 12,303,497 |
| Aragon Pharms., Inc. v. MSN Pharms. Inc., 26-7831 (D.N.J.) | 26-Jun-26 | Hon. Jennifer Choe-Groves | Radicava ORS® (edaravone oral suspension) | 12,599,586 |
| Shionogi Inc. v. Lupin Ltd., 26-7840 (D.N.J.) | 26-Jun-26 | Hon. Robert Kirsch | Zepzelca® (lurbinectedin injection) | 12,324,806 12,433,890 12,440,490 |
| Incyte Corp. v. Alembic Pharms. Ltd., 26-7841 (D.N.J.) | 26-Jun-26 | Hon. Christine P. O’Hearn | Jakafi® (ruxolitinib tablets) | 7,598,257 8,415,362 8,722,693 8,822,481 8,829,013 10,016,429 |
| Incyte Corp. v. MSN Pharms. Inc., 26-7949 (D.N.J.) | 30-Jun-26 | Hon. Christine P. O’Hearn | Jakafi® (ruxolitinib tablets) | 7,598,257 8,415,362 8,722,693 8,822,481 8,829,013 10,016,429 |
