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New ANDA Cases
Federal district court cases that are filed pursuant to the Hatch-Waxman Act
Second 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). |
|---|---|---|---|---|
| AbbVie Inc. v. Teva Pharms., Inc., 24-0374 (D. Del.) | Apr. 3, 2023 | Hon. Richard G. Andrews | Orilissa® (elagolix sodium tablets) | 11,542,239 |
| Ingenus Pharms., LLC v. Accord Healthcare, Inc., 23-0377 (D. Del.) | Apr. 3, 2023 | Hon. Colm F. Connolly | Cyclophosphamide intravenous solution | 10,993,952 |
| Actelion Pharms. US, Inc. v. Alembic Pharms. Ltd., 23-0383 (D. Del.) | Apr. 4, 2023 | Hon. Gregory B. Williams | Uptravi® (selexipag tablets) | 7,205,302 |
| Actelion Pharms. US, Inc. v. Alembic Pharms. Ltd., 23-1902 (D.N.J.) | Apr. 4, 2023 | Hon. Stanley R. Chesler | Opsumit® (macitentan tablets) | 7,094,781 |
| Catalyst Pharms., Inc. v. MSN Labs. Private Ltd., 23-1945 (D.N.J.) | Apr. 5, 2023 | Hon. Karen M. Williams | Fycompa® (perampanel oral suspension) | 8,722,497 |
| Actelion Pharms. US, Inc. v. Cipla Ltd., 23-0389 (D. Del.) | Apr. 6, 2023 | Hon. Gregory B. Williams | Uptravi® (selexipag for injection) | 8,791,122 9,284,280 |
| Bristol-Myers Squibb Co. v. Biocon Pharma Ltd., 23-0392 (D. Del.) | Apr. 6, 2023 | Hon. Gregory B. Williams | Eliquis® (apixaban tablets) | 9,326,945 |
| Bristol-Myers Squibb Co. v. ScieGen Pharms., Inc., 23-0393 (D. Del.) | Apr. 6, 2023 | Hon. Gregory B. Williams | Eliquis® (apixaban tablets) | 9,326,945 |
| Catalyst Pharms., Inc. v. MSN Labs. Private Ltd., 23-1961 (D.N.J.) | Apr. 6, 2023 | Hon. Karen M. Williams | Fycompa® (perampanel tablets) | 8,722,497 |
| Abraxis Bioscience, LLC v. Mylan Pharms. Inc., 23-0033 (N.D.W.V.) | Apr. 6, 2023 | Hon. Thomas S Kleeh | Abraxane® (paclitaxel protein-bound particles for injectable suspension) | 7,820,788 |
| Novartis Pharms. Corp. v. Nanjing Noratech Pharm. Co., Ltd., 23-0401 (D. Del.) | Apr. 10, 2023 | Hon. Richard G. Andrews | Entresto® (sacubitril / valsartan tablets) | 8,101,659 11,058,667 |
| Nexus Pharms., Inc. v. Gland Pharma Ltd., 23-2032 (D.N.J.) | Apr. 10, 2023 | Hon. Christine P. O’Hearn | Emerphed® (ephedrine sulfate injection) | 11,090,278 11,241,400 11,478,436 11,426,369 |
| Bayer Pharma AG v. Dr. Reddy’s Labs., Inc., 23-0410 (D. Del.) | Apr. 13, 2023 | Hon. Richard G. Andrews | Xarelto® (rivaroxaban tablets) | 10,828,310 |
| Celgene Corp. v. Accord Healthcare Inc., 23-0424 (D. Del.) | Apr. 18, 2023 | Hon. Richard G. Andrews | Onureg® (azacitidine tablets) | 11,571,436 |
| Pfizer Inc. v. Apotex Inc., 23-0445 (D. Del.) | Apr. 24, 2023 | Hon. Colm F. Connolly | Xeljanz® (tofacitinib) tablets | RE41,783 |
| AbbVie Inc. v. Hetero Labs Ltd., 23-0448 (D. Del.) | Apr. 24, 2023 | Hon. Richard G. Andrews | Orilissa® (elagolix sodium tablets) | 11,542,239 |
| AbbVie Inc. v. Prinston Pharm. Inc., 23-0470 (D. Del.) | Apr. 28, 2023 | Hon. Richard G. Andrews | Orilissa® (elagolix sodium tablets) | 10,537,572 10,682,351 |
| Merck Sharp & Dohme LLC v. Hetero USA Inc., 23-2364 (D.N.J.) | Apr. 28, 2023 | Hon. Claire C. Cecchi | Isentress® (raltegravir tablets) | 7,754,731 |
| Pacira Pharms., Inc. v. eVenus Pharms. Labs. Inc., 23-2367 (D.N.J.) | Apr. 28, 2023 | Hon Madeline Cox Arleo | Exparel® (bupivacaine liposome injectable suspension) | 11,033,495 |
| Astellas Pharma Inc. v. Ascent Pharms., Inc., 23-0486 (D. Del.) | 3-May-23 | Hon. Joseph F. Bataillon | Myrbetriq® (mirabegron extended-release tablets) | 10,842,780 |
| Bausch & Lomb, Inc. v. Lupin Ltd., 23-2452 (D.N.J.) | 3-May-23 | Hon. Georgette Castner | Lumify® (brimonidine tartrate ophthalmic solution) | 11,596,600 |
| Bausch & Lomb, Inc. v. Slayback Pharma LLC, 23-2454 (D.N.J.) | 3-May-23 | Hon. Georgette Castner | Lumify® (brimonidine tartrate ophthalmic solution) | 11,596,600 |
| Teva Pharms. Int’l GmbH v. BendaRx Corp., 23-0490 (D. Del.) | 4-May-23 | Hon. Colm F. Connolly | Treanda® (bendamustine HCl for injection) Bendeka® (bendamustine HCl for injection) | 8,436,190 8,445,524 8,609,863 8,669,279 8,791,270 8,883,836 8,895,756 9,533,955 9,572,887 8,076,366 8,461,350 |
| Astellas Pharma Inc. v. Ascent Pharms., Inc., 23-3372 (E.D.N.Y.) | 4-May-23 | Hon. Joan M. Azrack | Myrbetriq® (mirabegron extended-release tablets) | 10,842,780 |
| Gilead Sciences, Inc. v. Lupin Ltd., 23-0508 (D. Del.) | 9-May-23 | Hon. Maryellen Noreika | Symtuza® (darunavir / cobicistat / emtricitabine / tenofovir alafenamide tablets) | 10,039,718 10,786,518 |
| Bausch & Lomb Inc. v. Lupin Ltd., 23-2664 (D.N.J.) | 17-May-23 | Hon. Julien Xavier Neals | Lotemax® SM (loteprednol etabonate ophthalmic gel) | 11,534,395 |
| Bausch Health Ireland Ltd. v. Taro Pharms. Inc., 23-2684 (D.N.J.) | 17-May-23 | Hon. Stanley R. Chesler | Duobrii® (halobetasol propionate / tazarotene lotion) | 11,648,256 |
| Acerta Pharma BV v. Alembic Pharms. Ltd., 23-0548 (D. Del.) | 19-May-23 | Hon. Gregory B. Williams | Calquence® (acalabrutinib capsules) | 10,272,083 |
| Novartis Pharms. Corp. v. MSN Pharms. Inc., 23-0550 (D. Del.) | 19-May-23 | Hon. Gregory B. Williams | Kisqali® (ribociclib tablets) Kisqali® Femara® Co-Pack (ribociclib / letrozole tablets) | 8,962,630 9,416,136 |
| Bayer Pharma AG v. Teva Pharms. USA, Inc., 23-0551 (D. Del.) | 19-May-23 | Hon. Richard G. Andrews | Xarelto® (rivaroxaban tablets) | 10,828,310 |
| Nexus Pharms., Inc. v. Exela Pharma Sciences, LLC, 23-0555 (D. Del.) | 19-May-23 | Hon. Maryellen Noreika | Akovaz® (ephedrine sulfate solution for injection) Emerphed® (ephedrine sulfate solution for injection) | 11,571,398 |
| Mylan Pharms. Inc. v. Bayer Intellectual Property GmbH, 23-0556 (D. Del.) | 19-May-23 | Hon. Richard G. Andrews | Xarelto® (rivaroxaban tablets) | 9,415,053 |
| Theravance Biopharma R&D IP, LLC v . Orbicular Pharm. Technologies Private Ltd., 23-2843 (D.N.J.) | 24-May-23 | Hon. Karen M. Williams | Yupelri® (revefenacin inhalation solution) | 11,484,531 |
| Braintree Labs., Inc. v. Lupin Ltd., 23-2853 (D.N.J.) | 25-May-23 | Hon. Christine P. O’Hearn | Sutab® (sodium sulfate / magnesium sulfate / potassium chloride osmotic laxative tablets) | 10,143,656 11,033,498 11,382,864 |
| Vertex Pharms. Inc. v. Lupin Ltd., 23-0581 (D. Del.) | 26-May-23 | Hon. Richard G. Andrews | Kalydeco® (ivacaftor tablets) | 10,646,481 11,564,916 |
| Vertex Pharms. Inc. v. Aurobindo Pharma Ltd., 23-0582 (D. Del.) | 26-May-23 | Hon. Richard G. Andrews | Kalydeco® (ivacaftor tablets) | 10,646,481 11,564,916 |
| Vertex Pharms. Inc. v. Lupin Ltd., 23-0583 (D. Del.) | 26-May-23 | Hon. Richard G. Andrews | Kalydeco® (ivacaftor tablets) | 8,883,206 10,272,046 10,646,481 11,147,770 11,564,916 |
| Janssen Pharms., Inc. v. Alkem Labs. Ltd., 23-2939 (D.N.J.) | 30-May-23 | Hon. Karen M. Williams | Spravato® (esketamine nasal spray) | 10,869,844 11,173,134 11,311,500 11,446,260 |
| Janssen Pharms., Inc. v. Hikma Pharms. USA Inc., 23-2942 (D.N.J.) | 30-May-23 | Hon. Karen M. Williams | Spravato® (esketamine nasal spray) | 10,869,844 11,173,134 11,311,500 11,446,260 |
| Janssen Pharms., Inc. v. Sandoz Inc., 23-2943 (D.N.J.) | 30-May-23 | Hon. Karen M. Williams | Spravato® (esketamine nasal spray) | 10,869,844 11,173,134 11,311,500 11,446,260 |
| Janssen Pharms., Inc. v. Hikma Pharms. USA Inc., 23-0595 (D. Del.) | 31-May-23 | Hon. Colm F. Connolly | Spravato® (esketamine nasal spray) | 10,869,844 11,173,134 11,311,500 11,446,260 |
| Janssen Pharms., Inc. v. Sandoz Inc., 23-0597 (D. Del.) | 31-May-23 | Hon. Colm F. Connolly | Spravato® (esketamine nasal spray) | 10,869,844 11,173,134 11,311,500 11,446,260 |
| Celgene Corp. v. Deva Holding A.S., 23-2992 (D.N.J.) | 31-May-23 | Hon. Susan D. Wigenton | Revlimid® (lenalidomide capsules) | 7,465,800 7,855,217 |
| Evofem Biosciences, Inc. v. Padagis Israel Pharms. Ltd., 23-3003 (D.N.J.) | 1-Jun-23 | Hon. Zahid N. Quaraishi | Phexxi® (lactic acid / citric acid / potassium bitartrate vaginal gel) | 10,568,855 11,337,989 11,439,610 |
| Bayer Intellectual Property GmbH v. Auson Pharms. Inc., 23-3020 (D.N.J.) | 1-Jun-23 | Hon. Evelyn Padin | Xarelto® (rivaroxaban tablets) | 9,539,218 10,828,310 |
| Evofem Biosciences, Inc. v. Padagis Israel Pharms. Ltd., 23-0606 (D. Del.) | 2-Jun-23 | Hon. Colm F. Connolly | Phexxi® (lactic acid / citric acid / potassium bitartrate vaginal gel) | 10,568,855 11,337,989 11,439,610 |
| AbbVie Inc. v. Prinston Pharm. Inc., 23-0607 (D. Del.) | 2-Jun-23 | Hon. Richard G. Andrews | Orilissa® (elagolix sodium tablets) | 11,542,239 |
| Horizon Therapeutics USA Inc. v. Dr. Reddy’s Labs., Ltd., 23-0623 (D. Del.) | 7-Jun-23 | Hon. Maryellen Noreika | Rayos® (prednisone delayed-release tablets) | 9,504,699 |
| Array BioPharma Inc. v. Teva Pharms., Inc., 23-0625 (D. Del.) | 8-Jun-23 | Hon. Gregory B. Williams | Mektovi® (binimetinib tablets) | 9,562,016 9,598,376 9,980,944 |
| Teva Pharms. Int’l GmbH v. BendaRx Corp., 23-0633 (D. Del.) | 9-Jun-23 | Hon. Colm F. Connolly | Treanda® (bendamustine HCl for injection) Bendeka® (bendamustine HCl for injection) | 8,436,190 8,445,524 8,609,863 8,669,279 8,791,270 8,883,836 8,895,756 9,533,955 9,572,887 8,076,366 8,461,350 |
| Pfizer Inc. v. Annora Pharma Private Ltd., 23-0634 (D. Del.) | 9-Jun-23 | Hon. Colm F. Connolly | Xeljanz® (tofacitinib oral solution) | RE41,783 |
| Jazz Pharms. Ireland Ltd. v. Alkem Labs. Ltd., 23-3182 (D.N.J.) | 9-Jun-23 | Hon. Stanley R. Chesler | Xyrem® (sodium oxybate oral solution) | 8,772,306 9,050,302 9,486,426 10,213,400 10,864,181 11,253,494 |
| Hikma Pharms. USA Inc. v. Padagis Israel Pharms. Ltd., 23-0654 (D. Del.) | 14-Jun-23 | Hon. Gregory B. Williams | Kloxxado® (naloxone HCl nasal spray) | 10,722,510 10,973,814 11,135,155 11,617,713 11,628,139 |
| Merck KGaA v. Apotex Inc., 23-0655 (D. Del.) | 15-Jun-23 | Hon. Gregory B. Williams | Mavenclad® (cladribine tablets) | 7,713,947 8,377,903 10,849,919 |
| Bayer Pharma AG v. Macleods Pharms. Ltd., 23-0665 (D. Del.) | 16-Jun-23 | Hon. Richard G. Andrews | Xarelto® (rivaroxaban tablets) | 10,828,310 |
| Vertex Pharms. Inc. v. Sun Pharm. Indus. Ltd., 23-0666 (D. Del.) | 16-Jun-23 | Hon. Richard G. Andrews | Kalydeco® (ivacaftor tablets) | 10,646,481 11,564,916 |
| Hikma Pharms. USA Inc. v. Padagis Israel Pharms. Ltd., 23-0630 (W.D. Mich.) | 16-Jun-23 | Hon. Paul L. Maloney | Kloxxado® (naloxone HCl nasal spray) | 10,722,510 10,973,814 11,135,155 11,617,713 11,628,139 |
| Bausch Health Ireland Ltd. v. MSN Labs. Private Ltd., 23-3333 (D.N.J.) | 16-Jun-23 | Hon. Stanley R. Chesler | Trulance® (plecanatide tablets) | 11,142,549 11,319,346 |
| Teva Pharms. Int’l GmbH v. BendaRx USA Corp., 23-0788 (E.D. Va.) | 16-Jun-23 | Hon. Rossie D. Alston, Jr. | Treanda® (bendamustine HCl for injection) Bendeka® (bendamustine HCl for injection) | 8,436,190 8,445,524 8,609,863 8,669,279 8,791,270 8,883,836 8,895,756 9,533,955 9,572,887 8,076,366 8,461,350 |
| Actelion Pharms. Ltd. v. MSN Labs. Private Ltd., 23-3371 (D.N.J.) | 20-Jun-23 | Hon. Stanley R. Chesler | Opsumit® (macitentan tablets) | 7,094,781 |
| Bausch Health Ireland Ltd. v. Padagis Israel Pharms. Ltd., 23-3393 (D.N.J.) | 21-Jun-23 | Hon. Stanley R. Chesler | Arazlo® (tazarotene lotion) | 11,679,116 |
| Padagis Israel Pharms. Ltd. v. Bausch Health US, LLC, IPR2023-01114 (PTAB) | 21-Jun-23 | N/A | Arazlo® (tazarotene lotion) | 11,311,482 |
| Merck Sharp & Dohme LLC v. Biocon Pharma Ltd., 23-0683 (D. Del.) | 23-Jun-23 | Hon. Richard G. Andrews | Januvia® (sitagliptin phosphate tablets) | 7,326,708 |
| AbbVie Inc. v. Sun Pharm. Indus. Ltd., 23-0684 (D. Del.) | 23-Jun-23 | Hon. Richard G. Andrews | Orilissa® (elagolix sodium tablets) | 11,542,239 |
| Boehringer Ingelheim Pharms. Inc. v. Apotex Inc., 23-0685 (D. Del.) | 23-Jun-23 | Hon. Colm F. Connolly | Tradjenta® (linagliptin tablets) | 9,486,526 10,034,877 |
| Astellas Pharma Inc. v. MSN Pharms. Inc., 23-0689 (D. Del.) | 23-Jun-23 | Hon. Joseph F. Bataillon | Myrbetriq® (mirabegron extended-release tablets) | 10,842,780 |
| Bayer Intellectual Property GmbH v. Indoco Remedies Ltd., 23-0690 (D. Del.) | 23-Jun-23 | Hon. Richard G. Andrews | Xarelto® (rivaroxaban tablets) | 9,539,218 10,828,310 |
| Celgene Corp. v. MSN Labs. Private Ltd., 23-0699 (D. Del.) | 27-Jun-23 | Hon. Richard G. Andrews | Onureg® (azacitidine tablets) | 8,846,628 11,571,436 |
| Bausch & Lomb Inc. v. Dr. Reddy’s Labs. Ltd., 23-3463 (D.N.J.) | 27-Jun-23 | Hon. Robert Kirsch | Vyzulta® (latanoprostene bunod ophthalmic solution) | 7,273,946 7,629,345 7,910,767 8,058,467 |
| Amring Pharms. Inc. v. Rubicon Research Private Ltd., 23-3494 (D.N.J.) | 28-Jun-23 | Hon. Susan D. Wigenton | Lysteda® (tranexamic acid tablets) | 7,947,739 8,022,106 8,273,795 8,487,005 8,791,160 8,809,394 8,957,113 9,060,939 |
| Boehringer Ingelheim Pharms., Inc. v. Anobri Pharms. US, LLC, 23-3530 (D.N.J.) | 29-Jun-23 | Hon. Claire C. Cecchi | Spiriva® Respimat® (tiotropium bromide inhalation spray) | 7,284,474 7,896,264 7,396,341 9,027,967 7,837,235 8,733,341 |
| Boehringer Ingelheim Pharms., Inc. v. Anobri Pharms. US, LLC, 23-3531 (D.N.J.) | 29-Jun-23 | Hon. Claire C. Cecchi | Combivent® Respimat® (ipratropium bromide / albuterol inhalation spray) | 7,284,474 7,896,264 7,396,341 9,027,967 7,837,235 8,733,341 |
| Otsuka Pharm. Co., Ltd. v. Apotex Inc., 23-0710 (D. Del.) | 30-Jun-23 | Hon. Richard G. Andrews | Jynarque® (tolvaptan tablets) | 8,501,730 8,273,735 |
| Galderma Labs., L.P. v. Dr. Reddy’s Labs., Ltd., 23-0711 (D. Del.) | 30-Jun-23 | Hon. Stephanos Bibas | Oracea® (doxycycline capsules | 7,749,532 8,206,740 |
| Intercept Pharms., Inc. v. Zenara Pharma Private Ltd., 23-0714 (D. Del.) | 30-Jun-23 | Hon. Maryellen Noreika | Ocaliva® (obeticholic acid tablets) | RE48,286 |
| Boehringer Ingelheim Pharms. Inc. v. Anobri Pharms. US, LLC, 23-0715 (D. Del.) | 30-Jun-23 | Hon. Gregory B. Williams | Spiriva® Respimat® (tiotropium bromide inhalation spray) | 7,284,474 7,896,264 7,396,341 9,027,967 7,837,235 8,733,341 |
| Boehringer Ingelheim Pharms. Inc. v. Anobri Pharms. US, LLC, 23-0716 (D. Del.) | 30-Jun-23 | Hon. Gregory B. Williams | Combivent® Respimat® (ipratropium bromide / albuterol inhalation spray) | 7,284,474 7,896,264 7,396,341 9,027,967 7,837,235 8,733,341 |
| Pfizer Inc. v. Aurobindo Pharma Ltd., 23-0717 (D. Del.) | 30-Jun-23 | Hon. Colm F. Connolly | Xeljanz® XR (tofacitinib citrate extended-release tablets) | RE41,783 |
| Pfizer Inc. v. Sun Pharm. Indus. Ltd., 23-0718 (D. Del.) | 30-Jun-23 | Hon. Colm F. Connolly | Xeljanz® XR (tofacitinib citrate extended-release tablets) | RE41,783 |
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