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New ANDA Cases
Federal district court cases that are filed pursuant to the Hatch-Waxman Act
Fourth Quarter
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 |
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