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). |
| HQ Specialty Pharma Corp. v. Sagent Pharms (Inc.), 25-1227 (D. Del.) | Oct. 3, 2025 | Hon. Maryellen Noreika | calcium gluconate in sodium chloride injection | 10,130,646 |
| Neurelis, Inc. v. Padagis LLC, 25-1228 (D. Del.) | Oct. 3, 2025 | Hon. Maryellen Noreika | Valtoco® (diazepam nasal spray) | 12,324,852 12,337,061 |
| Impax Labs., LLC v. Sciegen Pharms., Inc., 25-1233 (D. Del.) | Oct. 6, 2025 | Hon. Gregory B. Williams | Rytary® (carbidopa / levodopa extended-release capsules) | 8,557,283 9,089,608 9,463,246 9,533,046 9,901,640 |
| HQ Specialty Pharma Corp. v. Cipla Ltd., 25-1236 (D. Del.) | Oct. 7, 2025 | Hon. Maryellen Noreika | calcium gluconate in sodium chloride injection | 10,130,646 |
| Bayer Healthcare Pharms. Inc. v. Aurobindo Pharma Ltd., 25-1246 (D. Del.) | Oct. 9, 2025 | Hon. Jennifer L. Hall | Kerendia® (finerenone tablets) | RE49,826 |
| Bayer Healthcare Pharms. Inc. v. Teva Pharms., Inc., 25-1247 (D. Del.) | Oct. 9, 2025 | Hon. Jennifer L. Hall | Kerendia® (finerenone tablets) | RE49,826 |
| American Regent, Inc. v. Cipla USA, Inc., 25-16422 (D.N.J.) | Oct. 9, 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 |
| Mylan Institutional LLC v. Alora Pharms., LLC, 25-5870 (N.D. Ga.) | Oct. 13, 2025 | Hon. Tiffany R. Johnson | isosulfan blue injection | 7,662,992 8,969,616 9,353,050 10,464,888 10,508,080 10,590,071 10,626,086 10,752,580 |
| Bayer Healthcare Pharms. Inc. v. Zydus Lifesciences Ltd., 25-1260 (D. Del.) | Oct. 15, 2025 | Hon. Jennifer L. Hall | Kerendia® (finerenone tablets) | RE49,826 |
| Bayer Healthcare Pharms. Inc. v. Apotex Inc., 25-1262 (D. Del.) | Oct. 15, 2025 | Hon. Jennifer L. Hall | Kerendia® (finerenone tablets) | RE49,826 |
| Janssen Pharmaceutica NV v. Natco Pharma Ltd., 25-16648 (D.N.J.) | Oct. 15, 2025 | Hon. Julien Xavier Neals | Balversa® (erdafitinib tablets) | 12,037,644 10,478,494 |
| Mitsubishi Tanabe Pharma Corp. v. Sandoz Inc., 25-16664 (D.N.J.) | Oct. 15, 2025 | Hon. Claire C. Cecchi | Radicava ORS® (edaravone oral suspension) | 10,987,341 11,241,416 11,478,450 11,826,352 11,957,660 12,194,025 12,285,409 12,310,946 |
| Mitsubishi Tanabe Pharma Corp. v. Shanghai Auzone Biological Technology Co., Ltd., 25-16665 (D.N.J.) | Oct. 15, 2025 | Hon. Claire C. Cecchi | Radicava ORS® (edaravone oral suspension) | 12,194,025 12,285,409 12,310,946 |
| Mitsubishi Tanabe Pharma Corp. v. Cipla USA, Inc., 25-16677 (D.N.J.) | Oct. 16, 2025 | Hon. Claire C. Cecchi | Radicava ORS® (edaravone oral suspension) | 12,194,025 12,310,946 |
| Mitsubishi Tanabe Pharma Corp. v. Apotex Inc., 25-16679 (D.N.J.) | Oct. 16, 2025 | Hon. Claire C. Cecchi | Radicava ORS® (edaravone oral suspension) | 12,194,025 12,285,409 12,310,946 |
| Mitsubishi Tanabe Pharma Corp. v. Lupin Ltd., 25-16680 (D.N.J.) | Oct. 16, 2025 | Hon. Claire C. Cecchi | Radicava ORS® (edaravone oral suspension) | 12,194,025 12,310,946 |
| Braintree Labs., Inc. v. Strides Pharma Inc., 25-16717 (D.N.J.) | Oct. 17, 2025 | Hon. Edward Kiel | Suflave® (polyethylene glycol / sodium sulfate / potassium chloride / magnesium sulfate / sodium chloride solution) | 12,290,529 |
| Bayer Healthcare Pharms. Inc. v. Macleods Pharms. Ltd., 25-1280 (D. Del.) | Oct. 20, 2025 | Hon. Jennifer L. Hall | Kerendia® (finerenone tablets) | RE49,826 |
| Bayer Healthcare Pharms. Inc. v. MSN Pharms. Inc., 25-1281 (D. Del.) | Oct. 20, 2025 | Hon. Jennifer L. Hall | Kerendia® (finerenone tablets) | RE49,826 |
| Bayer Healthcare Pharms. Inc. v. SABA Ilac Sanayi ve Ticaret A.S., 25-1282 (D. Del.) | Oct. 20, 2025 | Hon. Jennifer L. Hall | Kerendia® (finerenone tablets) | RE49,826 |
| Bayer Healthcare Pharms. Inc. v. ScieGen Pharms., Inc., 25-1283 (D. Del.) | Oct. 20, 2025 | Hon. Jennifer L. Hall | Kerendia® (finerenone tablets) | RE49,826 |
| Bayer Healthcare Pharms. Inc. v. Dr. Reddy’s Labs., Ltd., 25-1299 (D. Del.) | Oct. 23, 2025 | Hon. Jennifer L. Hall | Kerendia® (finerenone tablets) | RE49,826 |
| Celgene Corp. v. Sandoz Inc., 25-16878 (D.N.J.) | Oct. 23, 2025 | Hon. Esther Salas | Pomalyst® (pomalidomide capsules) | 8,828,427 9,993,467 10,555,939 |
| Pfizer Inc. v. Apotex Inc., 25-1306 (D. Del.) | Oct. 24, 2025 | Hon. Gregory B. Williams | Vyndamax® (tafamidis capsules) | 9,770,441 |
| Bayer Healthcare Pharms. Inc. v. Dr. Reddy’s Labs., Ltd., 25-16901 (D.N.J.) | Oct. 24, 2025 | Hon. Renee Marie Bumb | Kerendia® (finerenone tablets) | RE49,826 |
| Novartis Pharms. Corp. v. Apotex Inc., 25-1330 (D. Del.) | Oct. 30, 2025 | Hon. Gregory B. Williams | Mekinist® (trametinib dimethyl sulfoxide tablets) | 8,580,304 9,155,706 9,271,941 9,399,021 |
| ViiV Healthcare Co. v. Aurobindo Pharma Ltd., 25-1331 (D. Del.) | Oct. 30, 2025 | Hon. Gregory B. Williams | Tivicay® (dolutegravir sodium tablets) | 9,242,986 |
| AbbVie Inc. v. Deva Holding A.S., 25-1332 (D. Del.) | Oct. 30, 2025 | Hon. Maryellen Noreika | Vraylar® (cariprazine capsules) | 7,737,142 7,943,621 RE47,350 RE49,110 RE49,302 |
| Genentech, Inc. v. Natco Pharma Ltd., 25-17100 (D.N.J.) | Oct. 31, 2025 | Hon. Brian R. Martinotti | Evrysdi® (risdiplam oral solution) | 12,350,273 |
| Grünenthal GmbH v. MSN Labs. Private Ltd., 25-1343 (D. Del.) | Nov. 3, 2025 | Hon. Colm F. Connolly | Nucynta® ER (tapentadol extended-release tablets) | 8,536,130 11,344,512 |
| Exeltis USA, Inc. v. Glenmark Pharms. Ltd., 25-17250 (D.N.J.) | Nov. 6, 2025 | Hon. Esther Salas | Slynd® (drospirenone tablets) | 9,603,860 10,179,140 10,603,281 10,849,857 10,987,364 11,123,299 11,291,632 11,291,633 11,351,122 11,413,249 11,439,598 11,452,695 11,478,487 11,491,113 11,504,334 11,951,213 12,090,231 12,280,151 |
| Axsome Malta Ltd. v. Alkem Labs. Ltd., 25-17395 (D.N.J.) | Nov. 12, 2025 | Hon. Stanley R. Chesler | Sunosi® (solriamfetol tablets) | 12,384,743 12,390,419 |
| Vifor Fresenius Medical Care Renal Pharma Ltd. v. Gland Pharma Ltd., 25-1382 (D. Del.) | Nov. 13, 2025 | Hon. Colm F. Connolly | Korsuva® (difelikefalin acetate injection) | 7,402,564 7,713,937 7,727,963 8,217,007 8,236,766 8,486,894 8,536,131 9,334,305 9,359,399 10,017,536 10,138,270 10,793,596 |
| Kyowa Kirin Co., Ltd. v. Sun Pharm. Indus. Ltd., 25-17403 (D.N.J.) | Nov. 13, 2025 | Hon. Renee Marie Bumb | Nourianz® (istradefylline tablets) | 7,727,993 |
| Astellas Pharma Inc. v. Renata Ltd., 25-1383 (D. Del.) | Nov. 14, 2025 | Hon. Maryellen Noreika | Myrbetriq® (mirabegron extended-release tablets) | 10,842,780, 11,707,451 12,059,409 12,097,189 |
| Axsome Malta Ltd. v. Aurobindo Pharma USA, Inc., 25-17592 (D.N.J.) | Nov. 14, 2025 | Hon. Stanley R. Chesler | Sunosi® (solriamfetol tablets) | 12,263,145 12,318,362 12,390,419 |
| Salix Pharms., Inc. v. Ajanta Pharma Ltd., 25-17780 (D.N.J.) | Nov. 20, 2025 | Hon. John F. Murphy | Xifaxan® (rifaximin tablets) | 11,779,571 11,564,912 8,193,196 |
| Vifor Fresenius Medical Care Renal Pharma Ltd. v. Cipla Ltd, 25-1420 (D. Del.) | Nov. 21, 2025 | Hon. Colm F. Connolly | Korsuva® (difelikefalin acetate injection) | 7,402,564 |
| Incyte Corp. v. Dr. Reddy’s Labs., Inc., 25-17832 (D.N.J.) | Nov. 21, 2025 | Hon. Christine P. O’Hearn | Jakafi® (ruxolitinib tablets) | 7,598,257 8,415,362 8,722,693 8,822,481 8,829,013 |
| Incyte Corp. v. Eugia Pharma Specialities Ltd., 25-17833 (D.N.J.) | Nov. 21, 2025 | Hon. Christine P. O’Hearn | Jakafi® (ruxolitinib tablets) | 7,598,257 8,415,362 8,722,693 8,822,481 8,829,013 9,079,912 |
| Oyster Point Pharma, Inc. v. Lupin Ltd., 25-17843 (D.N.J.) | Nov. 21, 2025 | Hon. Michael E. Farbiarz | 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 |
| Vifor (Int’l) AG v. Xiromed Pharma Espana, S.L., 25-17822 (D.N.J.) | Nov. 21, 2025 | Hon. Georgette Castner | Injectafer® (ferric carboxymaltose injection) | 7,612,109 7,754,702 8,895,612 11,364,260 11,433,091 11,478,502 |
| Bayer Intellectual Property GmbH v. Mankind Pharma Ltd., 25-1429 (D. Del.) | Nov. 24, 2025 | Hon. Richard G. Andrews | Xarelto® (rivaroxaban tablets) | 9,539,218 |
| Ascendis Pharma A/S v. Biomarin Pharm. Inc., PGR2026-00013 (PTAB) | Nov. 24, 2025 | N/A | Voxzogo® (vosoritide injection) | 12,233,106 |
| Vifor Fresenius Medical Care Renal Pharma Ltd. v. MSN Labs. Private Ltd., 25-1440 (D. Del.) | Nov. 26, 2025 | Hon. Colm F. Connolly | Korsuva® (difelikefalin acetate injection) | 7,402,564 |
| Neurelis, Inc. v. Lupin Inc., 25-1443 (D. Del.) | Nov. 26, 2025 | Hon. Maryellen Noreika | Valtoco® (diazepam nasal spray) | 12,324,852 12,337,061 |
| Pacira Pharms., Inc. v. The Whiteoak Group, Inc., 25-1445 (D. Del.) | Nov. 26, 2025 | Hon. Jennifer L. Hall | Exparel® (bupivacaine Liposome injectable suspension) | 11,033,495 11,819,574 12,144,890 12,151,024 12,156,940 12,251,468 12,296,047 12,318,483 12,370,142 |
| Acrotech Biopharma Inc. v. Gland Pharma Ltd., 25-17982 (D.N.J.) | Nov. 26, 2025 | Hon. Zahid N. Quraishi | Evomela® (melphalan hydrochloride injection) | 10,864,183 10,940,128 11,020,363 |
| Mitsubishi Tanabe Pharma Corp. v. Zydus Pharms. (USA) Inc., 25-18032 (D.N.J.) | Nov. 29, 2025 | Hon. Claire C. Cecchi | Radicava ORS® (edaravone oral suspension) | 10,987,341 11,241,416 11,478,450 11,826,352 11,957,660 12,194,025 12,285,409 12,310,946 |
| Pacira Pharms., Inc. v. Qilu Pharm. (Hainan) Co., Ltd., 25-6742 (E.D. Pa.) | Dec. 1, 2025 | Hon. Nitza I. Quinones Alejandro | Exparel® (bupivacaine Liposome injectable suspension) | 11,033,495 11,819,574 12,144,890 12,151,024 12,156,940 12,251,468 12,296,047 12,318,483 12,370,142 |
| Bausch & Lomb Inc. v. Granules India Ltd., 25-18325 (D.N.J.) | Dec. 9, 2025 | Hon. Robert Kirsch | Lumify® (brimonidine tartrate ophthalmic solution) | 8,293,742 9,259,425 11,596,600 11,833,245 |
| Actelion Pharms. US, Inc. v. Apotex Inc., 25-1488 (D. Del.) | Dec. 10, 2025 | Hon. Gregory B. Williams | Uptravi® (selexipag tablets) | 8,791,122 9,284,280 |
| Azurity Pharms., Inc. v. Annora Pharma Private Ltd., 25-1493 (D. Del.) | Dec. 11, 2025 | Hon. Maryellen Noreika | Edarbyclor® (azilsartan medoxomil / chlorthalidone tablets) | 9,066,936 9,169,238 9,387,249 |
| Azurity Pharms., Inc. v. Aurobindo Pharma Ltd., 25-1507 (D. Del.) | Dec. 15, 2025 | Hon. Maryellen Noreika | Edarbi® (azilsartan kamedoxomil tablets) | 9,066,936 |
| Supernus Pharms., Inc. v. Macleods Pharms. Ltd., 25-18683 (D.N.J.) | Dec. 16, 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 |
| ViiV Healthcare Co. v. Zydus Pharms. (USA) Inc., 25-1520 (D. Del.) | Dec. 17, 2025 | Hon. Gregory B. Williams | Juluca® (dolutegravir sodium / rilpivirine HCl tablets) | 9,242,986 10,426,780 |
| Hope Medical Enterprises, Inc. v. Somerset Therapeutics, LLC, 25-1523 (D. Del.) | Dec. 17, 2025 | Hon. John F. Murphy | Sodium Thiosulfate Injection | 8,496,973 9,345,724 11,753,301 12,304,813 |
| Pfizer Inc. v. Apotex Ins., 25-1532 (D. Del.) | Dec. 18, 2025 | Hon. Gregory B. Williams | Vyndamax® (tafamidis capsules) | 9,770,441 |
| PH Health Ltd. v. Somerset Therapeutics, LLC, 25-1533 (D. Del.) | Dec. 18, 2025 | Hon. Jennifer L. Hall | Vasostrict® (vasopressin injection) | 9,919,026 9,925,233 9,925,234 9,962,422 9,968,649 9,974,827 9,981,006 10,010,575 12,186,362 |
| Mirum Pharms., Inc. v. Annora Pharma Private Ltd., 25-1537 (D. Del.) | Dec. 19, 2025 | Hon. Jennifer L. Hall | Livmarli® (maralixibat chloride oral solution) | 10,512,657 11,229,661 12,350,267 11,229,647 11,376,251 11,497,745 11,918,578 11,260,053 |
| Mirum Pharms., Inc. v. Sandoz Inc., 25-1538 (D. Del.) | Dec. 19, 2025 | Hon. Jennifer L. Hall | Livmarli® (maralixibat chloride oral solution) | 11,229,647 11,376,251 11,497,745 11,918,578 11,260,053 |
| Mirum Pharms., Inc. v. Zenara Pharma Private Ltd., 25-1539 (D. Del.) | Dec. 19, 2025 | Hon. Jennifer L. Hall | Livmarli® (maralixibat chloride oral solution) | 10,512,657 11,229,661 12,350,267 11,229,647 11,376,251 11,497,745 11,918,578 11,260,053 |
| Mirum Pharms., Inc. v. Zydus Lifesciences Global FZE, 25-1541 (D. Del.) | Dec. 19, 2025 | Hon. Jennifer L. Hall | Livmarli® (maralixibat chloride oral solution) | 10,512,657 11,229,661 12,350,267 11,229,647 11,376,251 11,497,745 11,918,578 11,260,053 |
| Allergan, Inc. v. Alembic Pharms. Ltd., 25-6986 (E.D.N.Y.) | Dec. 19, 2025 | Hon. Ann M. Donnelly | Lumigan® (bimatoprost ophthalmic solution) | 7,851,504 |
| AbbVie Inc. v. Apotex Inc., 25-18972 (D.N.J.) | Dec. 23, 2025 | Hon. Zahid N. Quraishi | Qulipta® (atogepant tablets) | 12,090,148 12,350,259 12,383,545 12,465,598 |
| Heron Therapeutics, Inc. v. Baxter Healthcare Corp., 25-1555 (D. Del.) | Dec. 23, 2025 | Hon. William C. Bryson | Cinvanti® (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 11,744,800 12,115,254 12,115,255 12,290,520 |
| Bristol-Myers Squibb Co. v. Azurity Pharms., Inc., 25-1558 (D. Del.) | Dec. 23, 2025 | Hon. Gregory B. Williams | Eliquis® (apixaban tablets) | 6,967,208 9,326,945 |
| Genentech, Inc. v. Sun Pharm. Indus. Ltd., 25-19019 (D.N.J.) | Dec. 29, 2025 | Hon. Evelyn Padin | Alecensa® (alectinib capsules) | 9,126,931 9,365,514 10,350,214 11,433,076 9,714,229 10,344,014 10,774,067 |
| AbbVie Inc. v. Macleods Pharms. Ltd., 25-19038 (D.N.J.) | Dec. 29, 2025 | Hon. Zahid N. Quraishi | Qulipta® (atogepant tablets) | 12,090,148 12,350,259 12,383,545 12,465,598 |
| AbbVie Inc. v. Dr. Reddy’s Labs., Ltd., 25-19039 (D.N.J.) | Dec. 29, 2025 | Hon. Zahid N. Quraishi | Qulipta® (atogepant tablets) | 12,090,148 12,350,259 12,383,545 12,465,598 |
