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New ANDA Cases
Federal district court cases that are filed pursuant to the Hatch-Waxman Act
Third Quarter
This New ANDA Cases 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). |
|---|---|---|---|---|
| Actelion Pharms. US, Inc. v. MSN Labs. Private Ltd., 23-0731 (D. Del.) | 6-Jul-23 | Hon. Gregory B. Williams | Uptravi® (selexipag for injection) | 8,791,122 9,284,280 |
| Biogen Inc. v. Zydus Worldwide DMCC, 23-0732 (D. Del.) | 6-Jul-23 | Hon. Gregory B. Williams | Vumerity® (diroximel fumarate delayed-release capsules) | 8,669,281 9,090,558 10,080,733 |
| Actelion Pharms. Ltd. v. Apotex Inc., 23-0734 (D. Del.) | 6-Jul-23 | Hon. Colm F. Connolly | Opsumit® (macitentan tablets) | 7,094,781 |
| CMP Development, LLC v. Hetero USA, Inc., 23-0747 (D. Del.) | 10-Jul-23 | Hon. Maryellen Noreika | CaroSpir® (spironolactone oral suspension) | 9,757,394 10,493,083 10,624,906 10,660,907 10,888,570 11,389,461 11,395,828 11,491,166 |
| AbbVie Inc. v. Lupin Ltd., 23-0750 (D. Del.) | 10-Jul-23 | Hon. Richard G. Andrews | Orilissa® (elagolix sodium tablets) | 11,542,239 |
| Mitsubishi Tanabe Pharma Corp. v. Cipla USA Inc., 23-0759 (D. Del.) | 12-Jul-23 | Hon. Colm F. Connolly | Radicava Ors® (edaravone oral suspension) | 10,987,341 11,241,416 11,478,450 |
| Gilead Sciences, Inc. v. Apotex Inc., 23-0774 (D. Del.) | 14-Jul-23 | Hon. Maryellen Noreika | Genvoya® (elvitegravir / cobicistat / emtricitabine / tenofovir alafenamide tablets) | 10,039,718 |
| Gilead Sciences, Inc. v. Apotex Inc., 23-0775 (D. Del.) | 14-Jul-23 | Hon. Maryellen Noreika | Genvoya® (elvitegravir / cobicistat / emtricitabine / tenofovir alafenamide tablets) | 8,754,065 9,296,769 |
| Alkermes Pharma Ireland Ltd. v. Slayback Pharma LLC, 23-3794 (D.N.J.) | 14-Jul-23 | Hon. Georgette Castner | Anjeso® (meloxicam injection) | 10,463,673 10,471,067 10,709,713 10,881,663 11,458,145 |
| Azurity Pharms., Inc. v. Cosette Pharms., Inc., 23-3830 (D.N.J.) | 18-Jul-23 | Hon. Evelyn Padin | Firvanq® (vancomycin HCl oral solution) | 11,638,692 |
| Oyster Point Pharma, Inc. v. Apotex, Inc., 23-3860 (D.N.J.) | 19-Jul-23 | Hon. Julien Xavier Neals | Tyrvaya® (varenicline solution) | 9,504,644 9,504,645 9,532,944 9,597,284 10,456,396 11,224,598 |
| Allergan Holdings Unlimited Co. v. MSN Labs. Private Ltd., 23-0794 (D. Del.) | 21-Jul-23 | Hon. Richard G. Andrews | Viberzi® (eluxadoline tablets) | 11,484,527 |
| Allergan Holdings Unlimited Co. v. Sun Pharm. Indus. Ltd., 23-0795 (D. Del.) | 21-Jul-23 | Hon. Richard G. Andrews | Viberzi® (eluxadoline tablets) | 11,484,527 |
| Boehringer Ingelheim Pharms., Inc. v. Alvogen, Inc., 23-3911 (D.N.J.) | 21-Jul-23 | Hon. Kevin McNulty | Spiriva® HandiHaler® (tiotropium bromide inhalation powder) | 9,010,323 |
| GW Research Ltd. v. Teva Pharms., Inc., 23-3914 (D.N.J.) | 21-Jul-23 | Hon. Michael Farbiarz | Epidiolex® (cannabidiol oral solution) | 11,633,369 |
| Currax Pharms. LLC v. Ajanta Pharma Ltd., 23-3937 (D.N.J.) | 24-Jul-23 | Hon. Christine P. O’Hearn | Silenor® (doxepin HCl tablets) | 7,915,307 8,513,299 9,107,898 9,486,43 9,572,814 9,861,607 10,238,620 10,653,660 10,653,662 11,110,074 |
| Janssen Pharmaceutica NV v. Natco Pharma Ltd., 23-3959 (D.N.J.) | 25-Jul-23 | Hon. Brian R. Martinotti | Balversa® (erdafitinib tablets) | 9,902,714 11,077,106 |
| Supernus Pharms., Inc. v. Ascent Pharms. Inc., 23-4015 (D.N.J.) | 26-Jul-23 | Hon. Georgette Castner | Trokendi XR® (topiramate extended-release capsules) | 8,298,576 8,298,580 8,663,683 8,877,248 8,889,191 8,992,989 9,549,940 9,555,004 9,622,983 10,314,790 |
| Novo Nordisk Inc. v. Lupin Ltd., 23-4027 (D.N.J.) | 27-Jul-23 | Hon. Georgette Castner | Victoza® (liraglutide recombinant solution injection) | 8,114,833 9,265,893 |
| Novo Nordisk Inc. v. Lupin Ltd., 23-4031 (D.N.J.) | 27-Jul-23 | Hon. Susan D. Wigenton | Saxenda® (liraglutide recombinant solution injection) | 8,114,833 8,684,969 8,920,383 9,108,002 9,132,239 9,457,154 9,616,180 9,687,611 9,775,953 9,861,757 10,220,155 10,357,616 10,376,652 11,097,063 11,311,679 RE46,363 |
| Astellas Pharma Inc. v. Lupin Ltd., 23-0819 (D. Del.) | 28-Jul-23 | Hon. Gregory B. Williams | Myrbetriq® (mirabegron extended-release tablets) | 11,707,451 |
| Supernus Pharms., Inc. v. Ascent Pharms. Inc., 23-5720 (E.D.N.Y.) | 28-Jul-23 | Hon. Gary R. Brown | Trokendi XR® (topiramate extended-release capsules) | 8,298,576 8,298,580 8,663,683 8,877,248 8,889,191 8,992,989 9,549,940 9,555,004 9,622,983 10,314,790 |
| Genentech, Inc. v. Sandoz, Inc., 23-4085 (D.N.J.) | 31-Jul-23 | Hon. Julien Xavier Neals | Esbriet® (pirfenidone tablets) | 10,188,637 |
| Azurity Pharms., Inc. v. Zydus Worldwide DMCC, 23-0833 (D. Del.) | Aug. 2, 2023 | Hon. Maryellen Noreika | Edarbi® (azilsartan medoxomil tablets) Edarbyclor® (azilsartan medoxomil / chlorthalidone tablets) | 9,066,936 9,169,238 9,387,249 |
| Azurity Pharms., Inc. v. Zydus Worldwide DMCC, 23-4152 (D.N.J.) | Aug. 3, 2023 | Hon. Robert Kirsch | Edarbi® (azilsartan medoxomil tablets) Edarbyclor® (azilsartan medoxomil / chlorthalidone tablets) | 9,066,936 9,169,238 9,387,249 |
| Boehringer Ingelheim Pharms. Inc. v. Ajanta Pharma Ltd., 23-0847 (D. Del.) | Aug. 4, 2023 | Hon. Colm F. Connolly | Glyxambi® (empagliflozin / linagliptin tablets) | 8,551,957 9,949,998 10,258,637 11,090,323 |
| Boehringer Ingelheim Pharms. Inc. v. Ajanta Pharma Ltd., 23-0848 (D. Del.) | Aug. 4, 2023 | Hon. Colm F. Connolly | Jardiance® (empagliflozin tablets) | 9,949,998 10,258,637 11,090,323 |
| Boehringer Ingelheim Pharms. Inc. v. Ajanta Pharma Ltd., 23-0849 (D. Del.) | Aug. 4, 2023 | Hon. Colm F. Connolly | Synjardy® (empagliflozin / metformin HCl tablets) | 10,258,637 11,090,323 |
| Par Pharm., Inc. v. Zydus Pharms. (USA) Inc., 23-0866 (D. Del.) | Aug. 8, 2023 | Hon. Richard G. Andrews | Chantix® (varenicline tartrate tablets) | 11,717,524 |
| Vifor Fresenius Medical Care Renal Pharma Ltd. v. Aurobindo Pharma Ltd., 23-0877 (D. Del.) | Aug. 10, 2023 | Hon. Maryellen Noreika | Velphoro® (sucroferric oxyhydroxide tablets) | 9,561,251 10,624,855 10,682,376 10,695,367 10,925,896 10,925,897 10,933,090 11,013,761 11,013,762 11,234,938 11,446,252 |
| Pfizer Inc. v. Dexcel Pharma Technologies Ltd., 23-0879 (D. Del.) | Aug. 10, 2023 | Hon. Gregory B. Williams | Vyndamax® (tafamidis capsules) | 7,214,695 7,214,696 9,770,441 |
| AbbVie Inc. v. Alkem Labs. Ltd., 23-0881 (D. Del.) | Aug. 10, 2023 | Hon. Richard G. Andrews | Orilissa® (elagolix sodium tablets) | 11,542,239 |
| AbbVie Inc. v. Zenara Pharma Private Ltd., 23-0892 (D. Del.) | Aug. 11, 2023 | Hon. Richard G. Andrews | Orilissa® (elagolix sodium tablets) | 11,542,239 |
| Fresenius Kabi USA, LLC v. Amneal Pharms. LLC, 23-4343 (D.N.J.) | Aug. 11, 2023 | Hon. Claire C. Cecchi | Diprivan® (propofol injection) | 8,476,010 |
| Allergan, Inc. v. Amneal Pharms. of New York, LLC, 23-6208 (E.D.N.Y.) | Aug. 17, 2023 | Hon. Gary R. Brown | Lumigan® (bimatoprost ophthalmic solution) | 7,851,504 8,278,353 8,299,118 8,309,605 8,338,479 8,524,777 8,586,630 8,772,338 8,933,120 8,933,127 9,155,716 9,241,918 |
| Pfizer Inc. v. Cipla Ltd., 23-0909 (D. Del.) | Aug. 18, 2023 | Hon. Gregory B. Williams | Vyndamax® (tafamidis capsules) | 9,770,441 |
| Theravance Biopharma R&D IP, LLC v. Eugia Pharma Specialties Ltd., 23-6667 (D.N.J.) | Aug. 21, 2023 | Hon. Karen M. Williams | Yupelri® (revefenacin inhalation solution) | 11,691,948 |
| Pfizer Inc. v. Aurobindo Pharma Ltd., 23-0923 (D. Del.) | Aug. 23, 2023 | Hon. Gregory B. Williams | Vyndaqel® (tafamidis meglumine capsules) | 7,214,695 |
| Pfizer Inc. v. Zenara Pharma Private Ltd., 23-0924 (D. Del.) | Aug. 23, 2023 | Hon. Gregory B. Williams | Vyndamax® (tafamidis capsules) | 9,770,441 |
| Alkermes Pharma Ireland Ltd. v. Nanjing Delova Biotech Co., Ltd., 23-9763 (D.N.J.) | Aug. 24, 2023 | Hon. Georgette Castner | Anjeso® (meloxicam injection) | 9,974,746 10,709,713 10,881,663 11,458,145 |
| Endo Par Innovation Co., LLC v. BPI Labs, LLC, 23-1953 (M.D. Fl.) | Aug. 29, 2023 | Hon. William F. Jung | Adrenalin® (epinephrine injection) | 9,119,876 9,295,657 |
| Curia IP Holdings, LLC v. Salix Pharms., Ltd., 23-13764 (D.N.J.) | Aug. 31, 2023 | Hon. Karen M. Williams | Xifaxan® (rifaximin tablets) | 11,739,099 |
| Amicus Therapeutics US, LLC v. Lupin Ltd., 23-0964 (D. Del.) | Sept. 1, 2023 | Hon. Christopher J. Burke | Galafold® (migalastat capsules) | 9,000,011 9,987,263 10,383,864 10,406,143 10,925,866 10,813,921 RE48,608 |
| Par Pharm., Inc. v. Mankind Pharma Ltd., 23-0399 (E.D. Tex.) | Sept. 1, 2023 | Hon. Rodney Gilstrap | Varenicline Tartrate | 11,717,524 |
| Par Pharm., Inc. v. Alkem Labs. Ltd., 23-0400 (E.D. Tex.) | Sept. 1, 2023 | Hon. Rodney Gilstrap | Varenicline Tartrate | 11,717,524 |
| United Therapeutics Corp. v. Liquidia Technologies, Inc., 23-0975 (D. Del.) | Sept. 5, 2023 | Hon. Richard G. Andrews | Tyvaso® (treprostinil inhalation solution) Tyvaso DPI® (treprostinil inhalation powder) Yutrepia® (treprostinil inhalation powder) | 10,716,793 |
| Azurity Pharms., Inc. v. Annora Pharma Private Ltd., 23-18420 (D.N.J.) | Sept. 7, 2023 | Hon. Christine P. O’Hearn | Qbrelis® (lisinopril oral solution) | 9,463,183 9,616,096 9,814,751 10,039,800 10,265,370 10,406,199 10,940,177 11,179,434 |
| Celgene Corp. v. Teva Pharms., Inc., 23-1008 (D. Del.) | Sept. 13, 2023 | Hon. Richard G. Andrews | Onureg® (azacitidine tablets) | 8,846,628 11,571,436 |
| Axsome Malta Ltd. v. Alkem Labs Ltd., 23-20354 (D.N.J.) | Sept. 13, 2023 | Hon. Madeline Cox Arleo | Sunosi® (solriamfetol tablets) | 8,440,715 8,877,806 9,604,917 10,351,517 10,195,151 10,512,609 11,439,597 10,912,754 10,959,976 11,160,779 10,940,133 11,560,354 11,648,232 |
| Heron Therapeutics, Inc. v. Mylan Pharms. Inc., 23-1015 (D. Del.) | Sept. 15, 2023 | Hon. William C. Bryson | Civanti® (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 |
| Celgene Corp. v. Natco Pharma Ltd., 23-1019 (D. Del.) | Sept. 18, 2023 | Hon. Richard G. Andrews | Onureg® (azacitidine tablets) | 8,846,628 11,571,436 |
| Fresenius Kabi USA, LLC v. Meitheal Pharms., Inc., 23-1050 (D. Del.) | Sept. 26, 2023 | Hon. Colm F. Connolly | Diprivan® (propofol injectable emulsion) | 8,476,010 |
| Orphalan SA v. Novitium Pharma LLC, 23-1079 (D. Del.) | Sept. 29, 2023 | Hon. Gregory B. Williams | Cuvrior® (triethylenetetramine tetrachloride tablets) | 10,988,436 11,072,577 |
| Azurity Pharms., Inc. v. Teva Pharms., Inc., 23-1080 (D. Del.) | Sept. 29, 2023 | Hon. Maryellen Noreika | Edarbyclor® (azilsartan medoxomil / chlorthalidone tablets) | 9,066,936 9,169,238 9,387,249 |
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