Federal district court cases that are filed pursuant to the Hatch-Waxman Act
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). |
| Astellas Pharma Inc. v. Ascent Pharms., Inc., 25-0035 (D.N.J.) | Jan. 2, 2025 | Hon. Michael A. Shipp | Xtandi® (enzalutamide tablets) |
7,709,517 8,183,274 12,161,628 |
| Avadel CNS Pharms., LLC v. Jazz Pharms., Inc., 25-0009 (D. Del.) | Jan. 3, 2025 | Hon. Gregory B. Williams | Lumryz® (sodium oxybate extended-release oral suspension) |
12,167,991 |
| Acacia Pharma Ltd. v. Galenicum Health S.L.U., 25-0010 (D. Del.) | Jan. 3, 2025 | Hon. Gregory B. Williams | Byfavo® (remimazolam for injection) |
9,561,236 9,827,251 |
| Nexus Pharms., LLC v. Hikma Pharms. USA Inc., 25-0018 (D. Del.) | Jan. 6, 2025 | Hon. Gregory B. Williams | Emerphed® (ephedrine sulfate for injection) |
11,464,752 11,426,369 11,571,398 |
| Avadel CNS Pharms., LLC v. Jazz Pharms., Inc., 25-0021 (D. Del.) | Jan. 7, 2025 | Hon. Gregory B. Williams | Lumryz® (sodium oxybate extended-release oral suspension) |
12,186,298 |
| Amneal Pharms. LLC v. Sandoz Inc., 25-0181 (D.N.J.) | Jan. 7, 2025 | Hon. Georgette Castner | Crexont® (carbidopa / levodopa extended-release capsules) |
10,098,845 10,292,935 10,688,058 10,973,769 10,987,313 11,357,733 11,622,941 11,666,538 11,986,449 12,064,521 12,109,185 12,128,141 |
| AstraZeneca Pharms. LP v. Natco Pharma Ltd., 25-0230 (D.N.J.) | Jan. 9, 2025 | Hon. Robert Kirsch | Lynparza® (olaparib tablets) |
12,178,816 |
| AstraZeneca Pharms. LP v. Sandoz Inc., 25-0231 (D.N.J.) | Jan. 9, 2025 | Hon. Robert Kirsch | Lynparza® (olaparib tablets) |
12,178,816 |
| AstraZeneca Pharms. LP v. Cipla Ltd., 25-0233 (D.N.J.) | Jan. 9, 2025 | Hon. Robert Kirsch | Lynparza® (olaparib tablets) |
12,178,816 |
| AstraZeneca Pharms. LP v. Zydus Pharms. (USA) Inc., 25-0234 (D.N.J.) | Jan. 9, 2025 | Hon. Robert Kirsch | Lynparza® (olaparib tablets) |
12,178,816 |
| Azurity Pharms., Inc. v. Exelixis, Inc., IPR2025-00427 (PTAB) | Jan. 9, 2025 | N/A | Cometriq® (cabozantinib S-malate capsules) Cabometyx® (cabozantinib S-malate tablets) |
12,128,039 |
| Ascerta Pharma B.V. v. MSN Pharms. Inc., 25-0043 (D. Del.) | Jan. 10, 2025 | Hon. Gregory B. Williams | Calquence® (acalabrutinib maleate tablets) |
10,272,083 11,059,829 |
| Astellas Pharma Inc. v. Creekwood Pharms. LLC, 25-0045 (D. Del.) | Jan. 10, 2025 | Hon. Joseph F. Bataillon | Myrbetriq® (mirabegron extended-release tablets) |
10,842,780 11,707,451 12,059,409 12,097,189 |
| Bausch Health Ireland Ltd. v. Mylan Pharms. Inc., 25-0003 (N.D.W.V.) | Jan. 13, 2025 | Hon. Thomas S. Kleeh | Trulance® (plecanatide tablets) |
12,146,003 |
| Avadel CNS Pharms., LLC v. Jazz Pharms., Inc., 25-0057 (D. Del.) | Jan. 14, 2025 | Hon. Gregory B. Williams | Lumryz® (sodium oxybate extended-release oral suspension) |
12,186,298 |
| Astellas Pharma Inc. v. Hikma Pharms. USA Inc., 25-0578 (D.N.J.) | Jan. 16, 2025 | Hon. Michael A. Shipp | Xtandi® (enzalutamide tablets) |
11,839,689 12,161,628 |
| Eagle Pharms., Inc. v. Apotex Inc., 25-0074 (D. Del.) | Jan. 17, 2025 | Hon. Jennifer L. Hall | Belrapzo® (bendamustine HCl injection) |
12,138,248 |
| Eagle Pharms., Inc. v. Slayback Pharma LLC, 25-0075 (D. Del.) | Jan. 17, 2025 | Hon. Jennifer L. Hall | Belrapzo® (bendamustine HCl injection) |
12,138,248 |
| Eagle Pharms., Inc. v. Baxter Healthcare Corp., 25-0079 (D. Del.) | Jan. 17, 2025 | Hon. Jennifer L. Hall | Belrapzo® (bendamustine HCl injection) |
12,138,248 |
| Padagis US LLC v. Neurelis, Inc., IPR2025-00464 (PTAB) | Jan. 17, 2025 | N/A | Valtoco® (diazepam nasal spray) |
8,895,546 |
| Padagis US LLC v. Neurelis, Inc., IPR2025-00465 (PTAB) | Jan. 17, 2025 | N/A | Valtoco® (diazepam nasal spray) |
11,241,414 |
| Padagis US LLC v. Neurelis, Inc., IPR2025-00466 (PTAB) | Jan. 17, 2025 | N/A | Valtoco® (diazepam nasal spray) |
11,793,786 |
| CSPC Pharm. Group Ltd. v. Ipsen Biopharm Ltd., IPR2025-00505 (PTAB) | Jan. 17, 2025 | N/A | Onivyde® (irinotecan HCl injection) |
11,344,552 |
| Novartis Pharms. Corp. v. MSN Labs. Private Ltd., 25-0081 (D. Del.) | Jan. 17, 2025 | Hon. Richard G. Andrews | Entresto® (sacubitril / valsartan tablets) |
8,101,659 |
| Axsome Malta Ltd. v. Aurobindo Pharma USA, Inc., 25-0643 (D.N.J.) | Jan. 21, 2025 | Hon. Madeline Cox Arleo | Sunosi® (solriamfetol tablets) |
12,102,609 |
| Merck Sharp & Dohme B.V. v. USV Private Ltd., 25-0694 (D.N.J.) | Jan. 23, 2025 | Hon. Claire C. Cecchi | Bridion® (sugammadex injection) |
RE44,733 |
| Harmony Biosciences Management, Inc. v. Lupin Ltd., 25-0102 (D. Del.) | Jan. 24, 2025 | Hon. Jennifer L. Hall | Wakix® (pitolisant HCl tablets) |
8,486,947 8,207,197 |
| American Regent, Inc. v. Xiromed, LLC, 25-0723 (D.N.J.) | Jan. 24, 2025 | Hon. Brian R. Martinotti | Tralement® (trace elements injection of zinc, copper, manganese, selenium) |
11,786,548 11,975,022 11,998,565 12,150,956 12,150,957 |
| Axsome Malta Ltd. v. Hetero USA Inc., 25-0801 (D.N.J.) | Jan. 29, 2025 | Hon. Madeline Cox Arleo | Sunosi® (solriamfetol tablets) |
12,102,609 |
| Apotex Inc. v. Alkermes Pharma Ireland Ltd., IPR2025-00514 (PTAB) | Jan. 30, 2025 | N/A | Vivitrol® (naltrexone extended-release suspension) |
7,919,499 |
| Intra-Cellular Therapies, Inc. v. Zydus Pharms. (USA) Inc., 25-0898 (D.N.J.) | Jan. 31, 2025 | Hon. Michael A. Shipp | Caplyta® (lumateperone capsules) |
9,956,227 10,960,009 11,026,951 RE48,839 |
| Celgene Corp. v. Cipla Ltd., 25-1147 (D.N.J.) | Feb. 10, 2025 | Hon. Esther Salas | Pomalyst® (pomalidomide capsules) |
8,828,427 9,993,467 10,555,939 |
| Bausch & Lomb Inc. v. Sandoz Inc., 25-1167 (D.N.J.) | Feb. 11, 2025 | Hon. Michael E. Farbiarz | Lotemax® SM (loteprednol etabonate ophthalmic gel) |
10,596,107 11,534,395 |
| Novartis Pharms. Corp. v. Cipla Ltd., 25-0186 (D. Del.) | Feb. 14, 2025 | Hon. Colm F. Connolly | Mayzent® (siponimod tablets) |
8,492,441 11,944,602 12,071,402 |
| Acadia Pharms. Inc. v. Zydus Lifesciences Ltd., 25-0187 (D. Del.) | Feb. 14, 2025 | Hon. Gregory B. Williams | Nuplazid® (pimavenserin tablets) |
7,601,740 7,659,285 7,732,615 10,517,860 10,953,000 |
| Otsuka Pharm. Co., Ltd. v. Alvogen, Inc., 25-0188 (D. Del.) | Feb. 14, 2025 | Hon. Jennifer L. Hall | Abilify Maintena® (aripiprazole injection) |
10,525,057 10,980,803 11,154,553 11,344,547 11,400,087 11,648,347 |
| AbbVie Inc. v. Hetero USA, Inc., 25-0190 (D. Del.) | Feb. 14, 2025 | Hon. Maryellen Noreika | Rinvoq® (upadacitinib extended-release tablets) |
11,607,411 11,564,922 |
| American Regent, Inc. v. Meitheal Pharms., Inc., 25-0191 (D. Del.) | Feb. 14, 2025 | Hon. Gregory B. Williams | Selenious Acid | 11,998,565 12,150,957 |
| American Regent, Inc. v. Meitheal Pharms., Inc., 25-1278 (D.N.J.) | Feb. 14, 2025 | Hon. Brian R. Martinotti | Selenious Acid | 11,998,565 12,150,957 |
| Vifor (Int’l) AG v. Apotex Inc., 25-0211 (D. Del.) | Feb. 20, 2025 | Hon. Colm F. Connolly | Injectafer® (ferric carboxymaltose injection) |
7,612,109 7,754,702 8,895,612 11,364,260 11,433,091 11,478,502 |
| Metacel Pharms. LLC v. Rubicon Research Private Ltd., 25-1382 (D.N.J.) | Feb. 20, 2025 | Hon. Evelyn Padin | Ozobax® (baclofen oral solution) |
10,610,502 |
| Novartis Pharms. Corp. v. Cipla Ltd., 25-0216 (D. Del.) | Feb. 21, 2025 | Hon. Gregory B. Williams | Tasingna® (nilotinib d-tartrate capsules) |
8,389,537 |
| Merck Sharp & Dohme LLC v. Sun Pharm. Indus. Ltd., 25-1424 (D.N.J.) | Feb. 24, 2025 | Hon. Claire C. Cecchi | Dificid® (fidaxomicin tablets) |
7,906,489 7,378,508 7,863,249 8,859,510 |
| Genentech, Inc. v. Zydus Lifesciences Global FZE, 25-1521 (D.N.J.) | Feb. 27, 2025 | Hon. Brian R. Martinotti | Evrysdi® (risdiplam solution) |
12,122,789 |
| Azurity Pharms., Inc. v. Heron Therapeutics, Inc., PGR2025-00035 (PTAB) | Feb. 28, 2025 | N/A | Cinvanti® (aprepitant injection) Aponvie® (aprepitant injection) |
12,115,254 |
| Azurity Pharms., Inc. v. Heron Therapeutics, Inc., PGR2025-00036 (PTAB) | Feb. 28, 2025 | N/A | Cinvanti® (aprepitant injection) Aponvie® (aprepitant injection) |
12,115,255 |
| Astellas Pharma Inc. v. Deva Holding A/S, 25-0233 (D. Del.) | Feb. 28, 2025 | Hon. Maryellen Noreika | Myrbetriq® (mirabegron extended-release tablets) |
10,842,780 11,707,451 12,059,409 12,097,189 |
| Endo USA, Inc. v. Baxter Healthcare Corp., 25-2365 (N.D. Ill.) | Mar. 5, 2025 | Hon. Franklin U. Valderrama | Adrenalin® (epinephrine in 0.9% sodium chloride injection) |
11,071,719 11,207,280 12,133,837 |
| Novo Nordisk Inc. v. Mylan Pharms. Inc., 25-0276 (D. Del.) | Mar. 10, 2025 | Hon. Colm F. Connolly | Wegovy® (semaglutide injection) |
12,214,017 |
| BioCryst Pharms., Inc. v. Annora Pharma Private Ltd., 25-0281 (D. Del.) | Mar. 10, 2025 | Hon. Jennifer L. Hall | Orladeyo® (berotralstat dihydrochloride capsules) |
10,662,160 11,117,867 11,618,733 |
| Nevakar Injectables, Inc. v. Baxter Healthcare Corp., 25-0301 (D. Del.) | Mar. 11, 2025 | Hon. Christopher J. Burke | Norepinephrine bitartrate injection | 12,245,996 |
| Sumitomo Pharma Switzerland GmbH v. Apotex Inc., 25-0311 (D. Del.) | Mar. 12, 2025 | Hon. Maryellen Noreika | Orgovyx® (relugolix tablets) |
11,795,178 12,097,198 12,144,809 |
| Sumitomo Pharma Switzerland GmbH v. Cipla Ltd., 25-0312 (D. Del.) | Mar. 12, 2025 | Hon. Maryellen Noreika | Orgovyx® (relugolix tablets) |
11,795,178 12,097,198 12,144,809 |
| Otsuka Pharm. Co., Ltd. v. Alkem Labs. Ltd., 25-0318 (D. Del.) | Mar. 13, 2025 | Hon. Richard G. Andrews | Jynarque® (tolvaptan tablets) |
8,501,730 10,905,694 8,273,735 |
| Incyte Corp. v. Taro Pharms. Inc., 25-1858 (D.N.J.) | Mar. 13, 2025 | 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 |
| Incyte Corp. v. Hikma Pharms. USA Inc., 25-1859 (D.N.J.) | Mar. 13, 2025 | Hon. Christine P. O’Hearn | Jakafi® (ruxolitinib tablets) |
7,598,257 8,415,362 8,722,693 8,822,481 8,829,013 |
| Opus Genetics, Inc. v. Sandoz Inc., 25-1895 (D.N.J.) | Mar. 14, 2025 | Hon. Zahid N. Quraishi | Ryzumvi™ (phentolamine ophthalmic solution) |
9,795,560 10,278,918 10,772,829 11,090,261 11,844,858 11,400,077 12,201,615 12,201,616 |
| Sumitomo Pharma Switzerland GmbH v. Aizant Drug Research Solutions Private Ltd., 25-0343 (D. Del.) | Mar. 19, 2025 | Hon. Maryellen Noreika | Orgovyx® (relugolix tablets) |
11,795,178 12,097,198 12,144,809 |
| Sumitomo Pharma Switzerland GmbH v. Hetero Labs Ltd., 25-0344 (D. Del.) | Mar. 19, 2025 | Hon. Maryellen Noreika | Orgovyx® (relugolix tablets) |
11,795,178 12,097,198 12,144,809 |
| Sumitomo Pharma Switzerland GmbH v. MSN Labs. Pvt. Ltd., 25-0345 (D. Del.) | Mar. 19, 2025 | Hon. Maryellen Noreika | Orgovyx® (relugolix tablets) |
11,795,178 12,097,198 |
| Exelixis, Inc. v. MSN Labs. Private Ltd., 25-0346 (D. Del.) | Mar. 19, 2025 | Hon. Richard G. Andrews | Cabometyx® (cabozantinib tablets) |
12,128,039 |
| Impax Labs., LLC v. Qilu Pharm. Co., Ltd., 25-1962 (D.N.J.) | Mar. 19, 2025 | Hon. Evelyn Padin | Rytary® (carbidopa / levodopa extended-release capsules) |
8,557,283 9,089,608 9,463,246 9,533,046 9,901,640 |
| Impax Labs., LLC v. Biocon Pharma Ltd., 25-1968 (D.N.J.) | Mar. 19, 2025 | Hon. Evelyn Padin | Rytary® (carbidopa / levodopa extended-release capsules) |
8,557,283 9,089,608 9,463,246 9,533,046 9,901,640 |
| Bayer Pharma AG v. Lupin Ltd., 25-0349 (D. Del.) | Mar. 20, 2025 | Hon. Richard G. Andrews | Xarelto® (rivaroxaban tablets) |
10,828,310 |
| Novartis Pharms. Corp. v. Alembic Pharms. Ltd., 25-0350 (D. Del.) | Mar. 20, 2025 | Hon. Jennifer L. Hall | Kisqali® (ribociclib tablets) |
8,324,225 8,415,355 8,685,980 8,962,630 9,416,136 |
| Bausch Health Ireland Ltd. v. Taro Pharms. Inc., 25-2000 (D.N.J.) | Mar. 20, 2025 | Hon. Madeline Cox Arleo | Cabtreo® (clindamycin phosphate / adapalene / benzoyl peroxide topical gel) |
8,288,434 9,561,208 10,220,049 10,624,918 11,389,467 12,128,059 12,133,859 12,138,278 |
| Eli Lilly & Co. v. Humanwell Pharm. US, Inc., 25-0362 (E.D. Mo.) | Mar. 21, 2025 | Hon. Stephen R. Clark | Reyvow® (lasmiditan tablets) |
11,053,214 |
| Eli Lilly & Co. v. Humanwell Pharm. US, Inc., 25-2020 (D.N.J.) | Mar. 21, 2025 | Hon. Evelyn Padin | Reyvow® (lasmiditan tablets) |
11,053,214 |
| Heron Therapeutics, Inc. v. Qilu Pharm. Co., Ltd., 25-0357 (D. Del.) | Mar. 21, 2025 | Hon William C. Bryson | Aponvie® (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 11,878,074 12,115,254 12,115,255 |
| Janssen Sciences Ireland Unlimited Co. v. Laurus Labs, Ltd., 25-2049 (D.N.J.) | Mar. 24, 2025 | Hon. Zahid N. Quraishi | Complera® (emtricitabine / rilpivirine / tenofovir disoproxil fumarate tablets) |
10,857,102 8,618,291 8,101,752 |
| Calliditas Therapeutics AB v. Zydus Pharms. (USA) Inc., 25-0368 (D. Del.) | Mar. 25, 2025 | Hon. Colm F. Connolly | Tarpeyo® (budesonide delayed-release capsules) |
11,896,719 12,171,882 12,171,883 |
| Urovant Sciences GmbH v. Apotex Inc., 25-0372 (D. Del.) | Mar. 26, 2025 | Hon. Gregory B. Williams | Gemtesa® (vibegron tablets) |
12,102,638 |
| Urovant Sciences GmbH v. Intas Pharms. Ltd., 25-0373 (D. Del.) | Mar. 26, 2025 | Hon. Gregory B. Williams | Gemtesa® (vibegron tablets) |
12,102,638 |
| Nevakar Injectables, Inc. v. InfoRLife SA, 25-2086 (D.N.J.) | Mar. 26, 2025 | Hon. Julien Xavier Neals | norepinephrine bitartrate in sodium chloride for injection | 12,245,996 |
| Salix Pharms., Inc. v. Mylan Pharms. Inc., 25-0024 (N.D.W.V.) | Mar. 26, 2025 | Hon. Thomas S. Kleeh | Xifaxan® (rifaximin tablets) |
11,779,571 11,564,912 8,193,196 |
| Sumitomo Pharma Switzerland GmbH v. Annora Pharma Private Ltd., 25-0380 (D. Del.) | Mar. 27, 2025 | Hon. Maryellen Noreika | Myfembree® (estradiol / norethindrone acetate / relugolix tablets) |
11,795,178 11,033,551 11,957,684 11,793,812 |
| Urovant Sciences GmbH v. Intas Pharms. Ltd., 25-0163 (E.D.N.C.) | Mar. 27, 2025 | Hon. Louise Wood Flanagan | Gemtesa® (vibegron tablets) |
12,102,638 |
| UCB Inc. v. Hikma Pharms. PLC, 25-0382 (D. Del.) | Mar. 28, 2025 | Hon. Jennifer L. Hall | Nayzilam® (midazolam nasal spray) |
8,217,033 8,809,322 9,289,432 9,687,495 |
| Almirall, LLC v. Taro Pharms., Inc., 25-0385 (D. Del.) | Mar. 28, 2025 | Hon. Colm F. Connolly | Klisyri® (tirbanibulin topical ointment) |
7,300,931 7,851,470 10,323,001 10,617,693 10,669,236 11,497,750 |
| InfoRLife SA v. Sagent Pharms. (Inc.), 25-0387 (D. Del.) | Mar. 28, 2025 | Hon. Colm F. Connolly | norepinephrine bitartrate in sodium chloride for injection | 10,888,534 |
