New ANDA Cases

Federal district court cases that are filed pursuant to the Hatch-Waxman Act

Second Quarter

GENERICally Speaking

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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