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). |
| Supernus Pharms., Inc. v. Appco Pharma LLC, 24-0807 (D. Del.) | July 1, 2025 | Hon. Jennifer L. Hall | Qelbree® (viloxazine extended-release capsules) | 9,358,204 9,603,85 9,662,338 11,324,753 11,458,143 12,121,523 |
| Supernus Pharms., Inc. v. Aurobindo Pharma Ltd., 24-0808 (D. Del.) | July 1, 2025 | Hon. Jennifer L. Hall | Qelbree® (viloxazine extended-release capsules) | 9,358,204 9,603,853 9,662,338 11,324,753 11,458,143 12,121,523 |
| Takeda Pharms. U.S.A., Inc. v. Lupin, Ltd., 25-12574 (D.N.J.) | July 1, 2025 | Hon. Robert Kirsch | Eohilia® (budesonide oral suspension) | 11,260,064 11,564,934 |
| Ferring Pharms. Inc. v. Alkem Labs. Ltd., 25-0810 (D. Del.) | July 2, 2025 | Hon. Colm F. Connolly | Clenpiq® (sodium picosulfate / magnesium oxide / anhydrous citric acid oral solution) | 9,827,231 10,624,879 11,191,753 |
| Azurity Pharms., Inc. v. Saba Ilac Sanayi ve Ticaret AS, 25-0814 (D. Del.) | July 2, 2025 | Hon. Maryellen Noreika | Edarbyclor® (azilsartan medoxomil / chlorthalidone tablets) | 9,066,936 9,169,238 9,387,249 |
| Neurelis, Inc. v. Padagis LLC, 25-0821 (D. Del.) | July 2, 2025 | Hon. Maryellen Noreika | Valtoco® (diazepam nasal spray) | 11,241,414 11,793,786 12,268,664 |
| Orion Corp. v. Alembic Pharms Ltd., 25-0825 (D. Del.) | July 3, 2025 | Hon. Jennifer L. Hall | Nubeqa® (darolutamide tablets) | 10.010.530 10.383.853 10.835.515 11.168.058 |
| Mitsubishi Tanabe Pharma Corp. v. Lupin Ltd., 25-0828 (D. Del.) | July 3, 2025 | Hon. Jennifer L. Hall | Radivaca Ors® (edaravone oral suspension) | 12,285,409 |
| Heron Therapeutics, Inc. v. Qilu Pharm. Co., Ltd., 25-0829 (D. Del.) | July 3, 2025 | Hon. William C. Bryson | Cinvanti® (aprepitant injectable emulsion) | 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 11,744,800 12,115,254 12,115,255 12,290,520 |
| Ascendis Pharma A/S v. Biomarin Pharm. Inc., 25-5696 (N.D. Cal.) | July 7, 2025 | Hon. P. Casey Pitts | Voxzogo® (vosoritide powder for injection) | RE48,267 |
| Janssen Pharms., Inc. v. Sun Pharm. Indus. Ltd., 25-13061 (D.N.J.) | July 9, 2025 | Hon. Claire C. Cecchi | Invega Sustenna® (palperidone palmitate extended-release injectable suspension) | 9,439,906 |
| Janssen Pharms., Inc. v. Sun Pharm. Indus. Ltd., 25-0857 (D. Del.) | July 10, 2025 | Hon. William C. Bryson | Invega Sustenna® (palperidone palmitate extended-release injectable suspension) | 9,439,906 |
| Hope Medical Enterprises, Inc. v. Accord Healthcare, Inc., 25-0860 (D. Del.) | July 10, 2025 | Hon. John F. Murphy | Sodium Thiosulfate Injection | 12,304,813 |
| Endo Operations Ltd. v. Baxter Healthcare Corp., 25-0861 (D. Del.) | July 10, 2025 | Hon. Jennifer L. Hall | Adrenalin® (epinephrine in 0.9% sodium chloride injection) | 11,071,719 11,207,280 12,133,837 10,653,646 11,083,698 |
| Boehringer Ingelheim Pharms. Inc. v. USV Private Ltd., 25-0862 (D. Del.) | July 10, 2025 | Hon. Colm F. Connolly | Jardiance® (empagliflozin tablets) | 8,551,957 11,090,323 12,115,179 |
| Braintree Labs., Inc. v. Lupin Ltd., 25-13133 (D.N.J.) | July 10, 2025 | Hon. Edward S. Kiel | Suflave® (polyethylene glycol /sodium sulfate / potassium chloride / magnesium sulfate / sodium chloride solution) | 12,239,659 12,290,529 |
| Novartis Pharms. Corp. v. Taro Pharms. USA, Inc., 25-13193 (D.N.J.) | July 11, 2025 | Hon. Georgette Castner | Promacta® (eltrombopag olamine tablets) | 8,052,993 8,052,994 8,062,665 8,071,129 8,828,430 |
| Supernus Pharms., Inc. v. Creekwood Pharms., LLC, 25-13201 (D. Del.) | July 11, 2025 | Hon. Michael E. Farbiarz | Qelbree® (viloxazine extended-release capsules) | 9,358,204 9,603,853 9,662,338 11,324,753 11,458,143 12,121,523 |
| Supernus Pharms., Inc. v. MSN Pharms. Inc., 25-13204 (D. Del.) | July 11, 2025 | Hon. Michael E. Farbiarz | Qelbree® (viloxazine extended-release capsules) | 9,358,204 9,603,853 9,662,338 11,324,753 11,458,143 12,121,523 |
| Supernus Pharms., Inc. v. Zenara Pharma Private Ltd., 25-13207 (D. Del.) | July 11, 2025 | Hon. Michael E. Farbiarz | Qelbree® (viloxazine extended-release capsules) | 9,358,204 9,603,853 9,662,338 11,324,753 11,458,143 12,121,523 |
| Incyte Corp. v. Sun Pharm. Indus., Inc., 25-13225 (D.N.J.) | July 11, 2025 | Hon. Christine P. O’Hearn | Jakafi® (ruxolitinib tablets) | 8,722,693 8,822,481 8,829,013 10,016,429 |
| Incyte Corp. v. Granules India Ltd., 25-13227 (D.N.J.) | July 11, 2025 | Hon. Christine P. O’Hearn | Jakafi® (ruxolitinib tablets) | 7,598,257 8,415,362 8,722,693 8,822,481 8,829,013 |
| Supernus Pharms., Inc. v. MSN Pharms. Inc., 25-0879 (D. Del.) | July 15, 2025 | Hon. Jennifer L. Hall | Qelbree® (viloxazine extended-release capsules) | 9,358,204 9,603,853 9,662,338 11,324,753 11,458,143 12,121,523 |
| Supernus Pharms., Inc. v. Creekwood Pharms., LLC, 25-0880 (D. Del.) | July 15, 2025 | Hon. Jennifer L. Hall | Qelbree® (viloxazine extended-release capsules) | 9,358,204 9,603,853 9,662,338 11,324,753 11,458,143 12,121,523 |
| Braintree Labs., Inc. v. Hetero USA, Inc., 25-13632 (D.N.J.) | July 22, 2025 | Hon. Christine P. O’Hearn | Sutab® (sodium sulfate / magnesium sulfate / potassium chloride osmotic laxative tablet) | 10,143,656 11,033,498 11,382,864 11,638,697 |
| Ipsen Biopharmaceuticals, Inc. v. Conjupro Biotherapeutics, Inc., 25-13647 (D.N.J.) | July 22, 2025 | Hon. Renee Marie Bumb | Onivyde® (irinotecan liposome injection) | 12,364,691 |
| Celgene Corp. v. Deva Holding A.S., 25-13687 (D.N.J.) | July 23, 2025 | Hon. Esther Salas | Pomalyst® (pomalidomide capsules) | 8,828,427 9,993,467 10,555,939 |
| Hikma Pharms. USA Inc. v. InfoRLife SA, 25-13688 (D.N.J.) | July 23, 2025 | Hon. Robert Kirsch | Immphentiv® (phenylephrine HCl injection) | 11,471,400 12,257,342 |
| BioDelivery Sciences Int’l, Inc. v. Alvogen PB Research & Development LLC, 25-0926 (D. Del.) | July 24, 2025 | Hon. Colm F. Connolly | Belbuca® (buprenorphine buccal film) | 8,147,866 9,901,539 |
| Novartis Pharms. Corp. v. Teva Pharms., Inc., 25-0928 (D. Del.) | July 24, 2025 | Hon. Gregory B. Williams | Mekinist® (trametinib dimethyl sulfoxide tablets) | 8,580,304 9,155,706 9,271,941 9,399,021 |
| Mitsubishi Tanabe Pharma Corp. v. Cipla USA, Inc., 25-0929 (D. Del.) | July 24, 2025 | Hon. Jennifer L. Hall | Radivaca Ors® (edaravone oral suspension) | 12,285,409 |
| Azurity Pharms., Inc. v. MSN Pharms. Inc., 25-13775 (D.N.J.) | July 25, 2025 | Hon. Sisan D. Wigenton | Fleqsuvy® (baclofen oral suspension) | 11,324,696 11,446,246 |
| Astellas Pharma Inc. v. Lupin Ltd., 25-13779 (D.N.J.) | July 25, 2025 | Hon. Michael A. Shipp | Xtandi® (enzalutamide tablets) | 11,839,689 12,161,628 |
| Gilead Sciences, Inc. v. Aspiro Pharma Ltd., 25-13936 (D.N.J.) | July 30, 2025 | Hon. Stanley R. Chesler | Veklury® (remdesivir injection) | 10,675,296 11,266,681 11,975,017 11,491,169 11,903,953 11,975,012 |
| Sumitomo Pharma Switzerland GmbH v. Sandoz Inc., 25-0970 (D. Del.) | Aug. 1, 2025 | Hon. Maryellen Noreika | Orgovyx® (relugolix tablets) | 11,795,178 12,325,714 12,097,198 12,144,809 12,336,990 |
| BPI Labs, LLC v. Eli Lilly and Co., IPR2025-01346 (PTAB) | Aug. 4, 2025 | N/A | Mounjaro® (tirzepatide injection) Zepbound® (tirzepatide injection) | 9,474,780 |
| Array BioPharma Inc. v. Alembic Pharms. Ltd., 25-1016 (D. Del.) | Aug. 13, 2025 | Hon. Colm F. Connolly | Vitrakvi® (larotrectinib sulfate capsules) | 9,782,414 10,172,861 10,285,993 10,799,505 10,813,936 |
| Bow River LLC v. Alembic Pharms. Ltd., 25-1016 (D. Del.) | Aug. 13, 2025 | Hon. Colm F. Connolly | Vitrakvi® (larotrectinib sulfate capsules) | 11,337,967 11,974,998 |
| Jazz Pharms. Ireland Ltd. v. Granules India Ltd., 25-14606 (D.N.J.) | Aug. 13, 2025 | 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 |
| American Regent, Inc. v. Hikma Pharms. USA Inc., 25-14671 (D.N.J.) | Aug. 15, 2025 | Hon. Brian R. Martinotti | Multrys® (trace elements zinc / copper / manganese / selenium injection) | 11,786,548 11,975,022 11,998,565 12,150,956 12,150,957 |
| Alkermes, Inc. v. Teva Pharms., Inc., 25-14685 (D.N.J.) | Aug. 15, 2025 | Hon. Karen M. Williams | Lybalvi® (olanzapine / samidorphan tablets) | 11,707,466 11,951,111 |
| Axsome Malta Ltd. v. Alkem Labs. Ltd., 25-14694 (D.N.J.) | Aug. 15, 2025 | Hon. Madeline Cox Arleo | Sunosi® (solriamfetol tablets) | 12,102,609 12,194,016 12,263,145 12,318,362 |
| Bayer Pharma AG v. Dr. Reddy’s Labs., Inc., 25-1043 (D. Del.) | Aug. 19, 2025 | Hon. Richard G. Andrews | Xarelto® (rivaroxaban tablets) | 10,828,310 |
| Vifor (Int’l) AG v. Orbicular Pharm. Techs. Pvt. Ltd., 25-1051 (D. Del.) | Aug. 21, 2025 | Hon. William C. Bryson | Injectafer® (ferric carboxymaltose injection) | 7,612,109 7,754,702 8,895,612 11,364,260 11,433,091 11,478,502 |
| Nexus Pharms., LLC v. Saba Ilac Sanayi ve Ticaret A.S., 25-14927 (D.N.J.) | Aug. 26, 2025 | Hon. Claire C. Cecchi | Emerphed® (ephedrine sulfate injection) | 11,090,278 11,241,400 11,478,436 11,426,369 |
| Alkermes, Inc. v. Apotex Corp., 25-14977 (D.N.J.) | Aug. 27, 2025 | Hon. Karen M. Williams | Lybalvi® (olanzapine / samidorphan tablets) | 11,707,466 11,951,111 12,390,474 |
| Alkermes, Inc. v. Apotex Corp., 25-1086 (D. Del.) | Aug. 28, 2025 | Hon. Colm F. Connolly | Lybalvi® (olanzapine / samidorphan tablets) | 11,707,466 11,951,111 12,390,474 |
| Actelion Pharms. Ltd. v. Seasons Biotechnology (Taizhou) Co. Ltd., 25-15027 (D.N.J.) | Aug. 28, 2025 | Hon. Stanley R. Chesler | Opsumit® (macitentan tablets) | 7,094,781 10,946,015 |
| PH Health Ltd. v. Fresenius Kabi USA, LLC, 25-1096 (D. Del.) | Aug. 29, 2025 | Hon. Jennifer L. Hall | Ephedrine Sulfate Injection | 10,869,845 |
| Baxter Healthcare Corp. v. PH Health Ltd., 25-15120 (D.N.J.) | Aug. 29, 2025 | Hon. Madeline Cox Arleo | Nexterone® (amiodarone HCl premixed injection) | 7,635,773 |
| ARS Pharms. Operations, Inc. v. Lupin Inc., 25-15123 (D.N.J.) | Aug. 29, 2025 | 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 & Lomb Inc. v. Saba Ilac Sanayi ve Ticaret A.S., 25-15127 (D.N.J.) | Aug. 29, 2025 | Hon. Stanley R. Chesler | Vyzulta® (latanoprostene bunod ophthalmic solution) | 8,058,467 |
| Actelion Pharms. US, Inc. v. VGYAAN Pharms. LLC, 25-15227 (D.N.J.) | Sept. 3, 2025 | Hon. Renee Marie Bumb | Uptravi® (selexipag tablets) | 7,205,302 |
| Onyx Therapeutics, Inc. v. Amneal Pharms. of NY, LLC, 25-1107 (D. Del.) | Sept. 4, 2025 | Hon. Gregory B. Williams | Kyprolis® (carfilzomib injection) | 7,737,112 |
| Jazz Pharms. Ireland Ltd. v. InvaGen Pharms., Inc., 25-15276 (D.N.J.) | Sept. 4, 2025 | Hon. Robert Kirsch | Zepzelca® (lurbinectedin injection) | 12,324,806 |
| Alkermes, Inc. v. MSN Pharms., Inc., 25-15324 (D.N.J.) | Sept. 5, 2025 | Hon. Karen M. Williams | Lybalvi® (olanzapine / samidorphan tablets) | 11,707,466 11,951,111 8,778,960 12,390,474 |
| Supernus Pharms., Inc. v. Macleods Pharms. Ltd., 25-15399 (D.N.J.) | Sept. 9, 2025 | Hon. Michael E. Farbiarz | Qelbree® (viloxazine extended-release capsules) | 9,358,204 9,603,853 9,662,338 11,324,753 11,458,143 12,121,523 |
| Astellas Pharma Inc. v. Hetero USA, Inc., 25-15434 (D.N.J.) | Sept. 10, 2025 | Hon. Michael A. Shipp | Xtandi® (enzalutamide tablets) | 11,839,689 12,161,628 |
| Azurity Pharms., Inc. v. Annora Pharma Private Ltd., 25-1139 (D. Del.) | Sept. 12, 2025 | Hon. Colm F. Connolly | Katerzia® (amlodipine benzoate oral suspension) | 10,799,453 11,471,409 11,484,498 11,701,326 11,918,685 12,053,461 12,336,984 |
| Apotex Inc. v. Ipsen Biopharm Ltd., IPR2025-01531 (P.T.A.B.) | Sept. 12, 2025 | N/A | Onivyde® (irinotecan HCl for injection) | 11,344,552 |
| Supernus Pharms., Inc. v. Macleods Pharms. Ltd., 25-1146 (D. Del.) | Sept. 15, 2025 | Hon. Jennifer L. Hall | Qelbree® (viloxazine extended-release capsules) | 9,358,204 9,603,853 9,662,338 11,324,753 11,458,143 12,121,523 |
| Teva Pharms. Int’l GmbH v. Almaject, Inc., 25-1168 (D. Del.) | Sept. 18, 2025 | Hon. Jennifer L. Hall | Bendeka® (bendamustine HCl injection) | 8,609,707 9,265,831 9,572,796 9,572,797 9,034,908 9,144,568 9,572,887 9,597,397 9,597,398 9,597,399 9,000,021 9,579,384 10,010,533 10,052,385 11,844,783 11,872,214 12,138,248 12,350,257 12,343,333 |
| GlaxoSmithKline LLC v. Sun Pharm. Indus. Ltd., 25-1170 (D. Del.) | Sept. 18, 2025 | Hon. Colm F. Connolly | Zejula® (niraparib tablets) | 8,071,623 11,091,459 11,673,877 |
| Kudos Pharms. Ltd. v. Sun Pharm. Indus. Ltd., 25-15825 (D.N.J.) | Sept. 19, 2015 | Hon. Robert Kirsch | Zejula® (niraparib tablets) | 8,859,562 |
| Glaxo Group Ltd. v. Transpire Bio Inc., 25-61939 (S.D. Fla.) | Sept. 25, 2025 | Hon. Melissa Damian | Breo Ellipta (fluticasone furoate / vilanterol trifenatate inhaler) | 11,116,721 8,534,281 8,746,242 8,161,968 |
| Axsome Therapeutics, Inc. v. Apotex Inc., 25-16038 (D.N.J.) | Sept. 26, 2025 | Hon. Michael E. Farbiarz | Symbravo® (meloxicam / rizatriptan tablets) | 9,821,075 10,029,010 10,058,614 10,137,131 10,195,278 10,265,324 10,363,31 10,369,224 10,426,839 10,463,736 10,471,014 10,471,069 10,512,692 10,512,693 10,517,950 10,532,101 10,537,642 10,561,664 10,583,144 10,653,777 10,688,102 10,688,185 10,695,429 10,695,430 10,702,535 10,702,602 10,722,583 10,729,696 10,729,697 10,729,773 |
| Orion Corp. v. MSN Pharms. Inc., 25-1201 (D. Del.) | Sept. 26, 2025 | Hon. Jennifer L. Hall | Nubeqa® (darolutamide tablets) | 10,010,530 10,383,853 10,835,515 11,168,058 |
| Pfizer Inc. v. Prinston Pharm. Inc., 25-1202 (D. Del.) | Sept. 26, 2025 | Hon. Colm F. Connolly | Xeljanz® (tofacitinib tablets) | RE41,783 |
| Boehringer Ingelheim Pharms. Inc. v. Ipca Labs. Ltd., 25-1207 (D. Del.) | Sept. 29, 2025 | Hon. Colm F. Connolly | Jardiance® (empagliflozin tablets) | 11,090,323 11,833,166 |
