New ANDA Cases

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

Fourth Quarter

GENERICally Speaking

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).
Novartis Pharms. Corp. v. Aurobindo Pharma USA Inc., 21-1407 (D. Del.) Oct. 1, 2021 Hon. Leonard P. Stark Entresto® (sacubitril / valsartan tablets) 11,058,667
Neurocrine Biosciences, Inc. v. Lupin Ltd., 21-1408 (D. Del.) Oct. 1, 2021 Hon. Maryellen Noreika Ingrezza® (valbenazine capsules) 11,026,931
11,026,939
11,040,029
Orexo AB v. Sun Pharm. Indus. Ltd., 21-17941 (D.N.J.) Oct. 1, 2021 Hon. Zahid N. Quaraishi Zubsolv® (buprenorphine / naloxone sublingual tablets) 11,020,387
11,020,388
Zogenix, Inc. v. Lupin Ltd., 21-1424 (D. Del.) Oct. 6, 2021 Hon. Colm F. Connolly Fintepla® (fenfluramine oral solution) 9,549,909
9,603,814
9,603,815
9,610,260
10,478,441
10,478,442
10,947,183
Pfizer Inc. v. Sinotherapeutics Inc., 21-1427 (D. Del.) Oct. 6, 2021 Hon. Leonard P. Stark Xeljanz XR® (tofacitinib extended-release tablets) 9,937,181
Bayer Healthcare LLC v. Apotex Inc., 21-1429 (D. Del.) Oct. 7, 2021 Hon. Leonard P. Stark Astepro® (azelastine HCl nasal spray) 8,071,073
8,518,919
9,919,050
Almirall, LLC v. Encube Ethicals Pvt. Ltd., 21-18534 (D.N.J.) Oct. 13, 2021 Hon. Madeline Cox Arleo Aczone® (dapsone gel) 9,517,219
Novartis Pharms. Corp. v. Crystal Pharm. (Suzhou) Co., Ltd., 21-1452 (D. Del.) Oct. 14, 2021 Hon. Leonard P. Stark Entresto® (sacubitril / valsartan tablets) 11,058,667
Janssen Pharms., Inc. v. Mylan Labs. Ltd., 21-18609 (D.N.J.) Oct. 14, 2021 Hon. Zahid N. Quaraishi Invega Trinza® (paliperidone palmitate extended release suspension) 10,143,693
Azurity Pharms., Inc. v. Bionpharma Inc., 21-1455 (D. Del.) Oct. 15, 2021 Hon. Leonard P. Stark Epaned® (enalapril oral solution) 11,141,405
Neurocrine Biosciences, Inc. v. Crystal Pharm. (Suzhou) Co., Ltd., 21-1464 (D. Del.) Oct. 18, 2021 Hon. Maryellen Noreika Ingrezza® (valbenazine capsules) 10,993,941
11,026,931
11,026,939
11,040,029
Pfizer Inc. v. Natco Pharma, Inc., 21-1466 (D. Del.) Oct. 19, 2021 Hon. Colm F. Connolly Ibrance® (palbociclib tablets) 11,065,250
Biofrontera Inc. v. Dusa Pharms., Inc., IPR2022-00056 (PTAB) Oct. 19, 2021 N/A Levulan® (aminolevulinic acid HCl topical solution) 10,357,567
Pfizer Inc. v. Synthon Pharms., Inc., 21-0817 (M.D.N.C.) Oct. 21, 2021 Hon. Loretta C. Biggs Ibrance® (palbociclib tablets) 11,065,250
Boehringer Ingelheim Pharms. Inc. v. Aurobindo Pharma Ltd., 21-1485 (D. Del.) Oct. 22, 2021 Hon. Colm F. Connolly Jardiance® (empagliflozin tablets) Glyxambi® (empagliflozin / linagliptin tablets) Synjardy® (empagliflozin / metformin tablets) Synjardy® XR (empagliflozin / metformin extended release tablets) 11,090,323
Boehringer Ingelheim Pharms. Inc. v. Lupin Ltd., 21-1486 (D. Del.) Oct. 22, 2021 Hon. Colm F. Connolly Jardiance® (empagliflozin tablets) Glyxambi® (empagliflozin / linagliptin tablets) Synjardy® XR (empagliflozin / metformin extended release tablets) Trijardy XR® (empagliflozin / linagliptin / metformin extended release tablets) 11,090,323
Boehringer Ingelheim Pharms. Inc. v. Sun Pharm. Industries Ltd., 21-1487 (D. Del.) Oct. 22, 2021 Hon. Colm F. Connolly Jardiance® (empagliflozin tablets) Glyxambi® (empagliflozin / linagliptin tablets) Synjardy® XR (empagliflozin / metformin extended release tablets) Trijardy XR® (empagliflozin / linagliptin / metformin extended release tablets) 11,090,323
Azurity Pharms., Inc. v. CoreRx, Inc., 21-2515 (M.D. Fla.) Oct. 26, 2021 Hon. Thomas P. Barber Epaned® (enalapril oral solution) 11,040,023
11,141,405
Azurity Pharms., Inc. v. CoreRx, Inc., 21-1522 (D. Del.) Oct. 27, 2021 Hon. Leonard P. Stark Epaned® (enalapril oral solution) 11,040,023
11,141,405
Novartis Pharms. Corp. v. HEC Pharm Co., Ltd., 21-1530 (D. Del.) Oct. 27, 2021 Hon. Leonard P. Stark Gilenya® (fingolimod capsules) 10,543,179
Zoegnix, Inc. v. Apotex Inc., 21-1533 (D. Del.) Oct. 28, 2021 Hon. Colm F. Connolly Fintepla® (fenfluramine oral solution) 10,947,183
10,950,331
Bayer Healthcare LLC v. Yabao Pharm. Co., Ltd. Beijing, 21-1549 (D. Del.) Oct. 29, 2021 Hon. Leonard P. Stark Nexavar® (sorafenib tosylate tablets) 8,877,933
9,737,488
Neurocrine Biosciences, Inc. v. Zydus Pharms. (USA) Inc., 21-1553 (D. Del.) Oct. 29, 2021 Hon. Maryellen Noreika Ingrezza® (valbenazine capsules) 10,993,941
11,026,931
11,026,939
11,040,029
Neurocrine Biosciences, Inc. v. Zydus Pharms. (USA) Inc., 21-19466 (D.N.J.) Oct. 29, 2021 Hon. Kevin McNulty Ingrezza® (valbenazine capsules) 10,993,941
11,026,931
11,026,939
11,040,029
ViiV Healthcare Co. v. Lupin Ltd., 21-1561 (D. Del.) Nov. 2, 2021 Hon. Mitchell S. Goldberg Tivicay PD™ (dolutegravir tablets) 9,242,986
Boehringer Ingelheim Pharms. Inc. v. Sun Pharm. Indus. Ltd., 21-1573 (D. Del.) Nov. 5, 2022 Hon. Colm F. Connolly Synjardy® (empagliflozin / metformin tablets) 7,579,449
10,258,637
11,090,323
Bayer Healthcare LLC v. Aurobindo Pharma Ltd., 21-1575 (D. Del.) Nov. 5, 2021 Hon. Leonard P. Stark Astepro® (azelastine HCl nasal spray) 8,071,073
8,518,919
9,919,050
Slayback Pharma LLC v. Eye Therapies, LLC, IPR2022-00142 (PTAB) Nov. 4, 2021 N/A Lumify® (brimonidine tartrate ophthalmic solution) 8,293,742
Slayback Pharma LLC v. Eye Therapies, LLC, IPR2022-00146 (PTAB) Nov. 4, 2021 N/A Lumify® (brimonidine tartrate ophthalmic solution) 9,259,425
Pacira Pharms., Inc. v. eVenus Pharms. Labs. Inc., 21-19829 (D.N.J.) Nov. 8, 2021 Hon. Madeline Cox Arleo Exparel® (bupivacaine liposome injectable suspension) 11,033,495
Baudax Bio, Inc. v. Axsome Therapeutics, Inc., 21-1585 (D. Del.) Nov. 9, 2021 Hon. Leonard P. Stark Anjeso® (meloxicam injection) rizatriptan benzoate / meloxicam for injection 8,512,727
10,471,067
Mylan Institutional LLC v. Hong Kong King-Friend Industrial Co., Ltd., 21-0419 (E.D. Tex.) Nov. 9, 2021 Hon. Rodney Gilstrap isosulfan blue for injection 9,353,050
10,626,086
10,752,580
Jazz Pharms., Inc. v. Avadel Pharms. plc, 21-1594 (D. Del.) Nov. 10, 2021 Hon. Maryellen Noreika Xyrem® (sodium oxybate oral solution) 11,147,782
Puma Biotechnology, Inc. v. Sandoz Inc., 21-19918 (D.N.J.) Nov. 10, 2021 Hon. Renee Marie Bumb Nerlynx® (neratinib tablets) 7,399,865
Taro Pharm. Indus. Ltd. v. Encube Ethicals Pvt. Ltd., 21-1614 (D. Del.) Nov. 15, 2021 Hon. Richard G. Andrews Ovide® (malathion lotion) 7,560,445
7,977,324
Gilead Sciences, Inc. v. Lupin Ltd., 21-1615 (D. Del.) Nov. 15, 2021 Hon. Maryellen Noreika Symtuza® (darunavir / cobicistat / emtricitabine / tenofovir alafenamide) 8,754,065
9,296,769
Merck Sharp & Dohme Corp. v. Scigen Pharms., Inc., 21-1616 (D. Del.) Nov. 15, 2021 Hon. Richard G. Andrews Januvia® (sitagliptin phosphate tablets) 7,326,708
Eagle Pharms., Inc. v. Hospira, Inc., 21-1619 (D. Del.) Nov. 16, 2021 Hon. Colm F. Connolly Bendeka® (bendamustine HCl for injection) 11,103,483
Gilead Sciences, Inc. v. Lupin Ltd., 21-1621 (D. Del.) Nov. 16, 2021 Hon. Maryellen Noreika Symtuza® (darunavir / cobicistat / emtricitabine / tenofovir alafenamide) 10,039,718
10,786,518
8,497,396
9,428,473
Celgene Corp. v. Alembic Pharms. Ltd., 21-20099 (D.N.J.) Nov. 18, 2021 Hon. Susan D. Wigenton Revlimid® (lenalidomide capsules) 7,465,800
7,855,217
7,968,569
8,530,498
8,648,095
9,101,621
9,101,622
Novartis Pharms. Corp. v. Sun Pharm. Indus. Ltd., 21-1656 (D. Del.) Nov. 23, 2021 Hon. Leonard P. Stark Xiidra® (lifitegrast ophthalmic solution) 11,058,677
8,927,574
9,353,088
9,890,141
9,085,553
Bial-Portela & Ca S.A. v. Aurobindo Pharma Ltd., 21-1682 (D. Del.) Nov. 29, 2021 Hon. Colm F. Connolly Aptiom® (eslicarbazepine acetate tablets) 8,372,431
9,206,135
9,566,244
9,643,929
9,750,747
9,763,954
10,675,287
10,695,354
10,702,536
10,912,781
Hikma Pharms. USA Inc. v. Amarin Pharms. Ireland Ltd., IPR2022-00215 (PTAB) Nov. 30, 2021 N/A Vascepa® (icosapent ethyl capsules) 8,642,077
Azurity Pharms., Inc. v. Aurobindo Pharma Ltd., 21-1707 (D. Del.) Dec. 2, 2021 Hon. Leonard P. Stark Epaned® (enalapril oral solution) 10,786,482
10,918,621
11,040,023
Taro Pharms. U.S.A., Inc. v. Lupin Ltd., 21-20320 (D.N.J.) Dec. 2, 2021 Hon. Christine P. O’Hearn Topicort® (desoximetasone topical spray) 8,277,780
8,715,624
Galderma Labs., L.P. v. Lupin Inc., 21-1710 (D. Del.) Dec. 3, 2021 Hon. Leonard P. Stark Oracea® (doxycycline capsules) 7,749,532
8,206,740
8,394,405
8,394,406
8,470,364
8,709,478
HQ Specialty Pharma Corp. v. Fresenius Kabi USA, L.L.C., 21-1714 (D. Del.) Dec. 3, 2021 Hon. Maryellen Noreika calcium gluconate in sodium chloride for injection 10,130,646
10,342,813
Sun Pharm. Indus. Ltd. v. Eli Lilly and Co., 21-2971 (S.D. Ind.) Dec. 6, 2021 Hon. Jane Magnus-Stinson Forteo® (teriparatide for injection) 7,517,334
Bristol-Myers Squibb Co. v. Eugia Pharma Specialties, Ltd., 21-20409 (D.N.J.) Dec. 8, 2021 Hon. Kevin McNulty Sprycel® (dasatinib tablets) 7,491,725
8,680,103
Gilead Sciences, Inc. v. Aurobindo Pharma Ltd., 21-1735 (D. Del.) Dec. 10, 2021 Hon. Leonard P. Stark Letairis® (ambrisentan tablets) 8,377,933
9,474,752
9,549,926
InfoRLife SA v. Sun Pharm. Indus., Ltd., 21-1740 (D. Del.) Dec. 10, 2021 Hon. Colm F. Connolly midazolam in sodium chloride solution for injection 10,966,990
Celgene Corp. v. Hikma Pharms. USA, Inc., 21-20459 (D.N.J.) Dec. 10, 2021 Hon. Susan D. Wigenton Revlimid® (lenalidomide capsules) 7,977,357
8,193,219
8,431,598
Novartis Pharms. Corp. v. Hetero USA Inc., 21-1760 (D. Del.) Dec. 16, 2021 Hon. Leonard P. Stark Entresto® (sacubitril / valsartan tablets) 11,058,667
InfoRLife SA v. Hikma Pharms. USA Inc., 21-1764 (D. Del.) Dec. 16, 2021 Hon. Colm F. Connolly midazolam in sodium chloride solution for injection 10,966,990
Boehringer Ingelheim Pharms. Inc. v. Mankind Pharma Ltd., 21-1766 (D. Del.) Dec. 16, 2021 Hon. Colm F. Connolly Jardiance® (empagliflozin tablets) 11,090,323
Bayer Healthcare LLC v. Amneal Pharms. LLC, 21-1770 (D. Del.) Dec. 17, 2021 Hon. Leonard P. Stark Astepro® (azelastine HCl nasal spray) 8,071,073
8,518,919
9,919,050
Astellas Pharma Inc. v. Prinston Pharm. Inc., 21-1771 (D. Del.) Dec. 17, 2021 Hon. Joseph F. Bataillon Myrbetriq® (mirabegron extended-release tablets) 10,842,780
Novartis Pharms. Corp. v. Mylan Pharms. Inc., 21-0146 (N.D.W.V.) Dec. 20, 2021 Hon. Irene M. Keeley Entresto® (sacubitril / valsartan tablets) 11,058,667
Novo Nordisk Inc. v. Teva Pharms., Inc., 21-1782 (D. Del.) Dec. 21, 2021 Hon. Colm F. Connolly Saxenda® (liraglutide recombinant solution injection) 7,762,994
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
9,968,659
10,220,155
10,357,616
10,376,652
11,097,063
RE46,363
Novo Nordisk Inc. v. Hikma Pharms. USA Inc., 21-1783 (D. Del.) Dec. 21, 2021 Hon. Colm F. Connolly Victoza® (liraglutide recombinant solution injection) 8,579,869
7,762,994
8,114,833
9,265,893
Janssen Pharms., Inc. v. Tolmar, Inc., 21-1784 (D. Del.) Dec. 21, 2021 Hon. Richard G. Andrews Invega Sustenna® (paliperidone palmitate extended-release injectable suspension) 9,439,906
Astellas US LLC v. Hikma Pharms. USA, Inc., 21-1785 (D. Del.) Dec. 22, 2021 Hon. Colm F. Connolly Lexiscan® (regadenoson for injection) 8,106,183
RE 47,301
8,524,883
Novartis Pharms. Corp. v. Torrent Pharma Inc., 21-1794 (D. Del.) Dec. 22, 2021 Hon. Leonard P. Stark Entresto® (sacubitril / valsartan tablets) 11,058,667
Celgene Corp. v. Accord Healthcare Inc., 21-1795 (D. Del.) Dec. 22, 2021 Hon. Richard G. Andrews Onureg® (azacitidine tablets) 8,846,628
Novartis Pharms. Corp. v. Crystal Pharm. (Suzhou) Co., Ltd., 21-1797 (D. Del.) Dec. 22, 2021 Hon. Leonard P. Stark Entresto® (sacubitril / valsartan tablets) 11,135,192
Allergan, Inc. v. Aurobindo Pharma Ltd., 21-1808 (D. Del.) Dec. 23, 2021 Hon. Richard G. Andrews Alphagan® (brimonidine tartrate ophthalmic solution) 8,858,961
Eisai Co., Ltd. v. Aurobindo Pharma Ltd., 21-20723 (D.N.J.) Dec. 27, 2021 Hon. Christine P. O’Hearn Banzel® (rufinamide oral suspension) 6,740,669
Currax Pharms. LLC v. Aurolife Pharma LLC, 21-20765 (D.N.J.) Dec. 30, 2021 Hon. Christine P. O’Hearn Silenor® (doxepin HCl) 7,915,307
8,513,299
9,107,898
9,486,437
9,532,971
9,572,814
9,861,607
9,907,780
10,238,620
10,548,871
10,653,660
10,653,662
11,096,920
11,110,074

Oren D. Langer

Partner

Managing Partner, New York Office

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