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New ANDA Cases
Winter 2020
| Case Name | Date Filed | Judge | Drug | Patent No(s). |
|---|---|---|---|---|
| Belcher Pharms., LLC v. Hospira, Inc., 19-1854 (D. Del.) | Oct. 3, 2019 | Hon. Richard G. Andrews | Abboject® (epinephrine for injection) | 10,004,700 10,039,728 |
| Boehringer Ingelheim Pharms. Inc. v. Aurobindo Pharma Ltd., 19-1862 (D. Del.) | Oct. 3, 2019 | Hon. Colm F. Connolly | Jardiance® (empagliflozin tablets) Glyxambi® (empagliflozin / linagliptin tablets) Synjardy® (empagliflozin / metformin tablets) Synjardy® XR (empagliflozin / metformin extended-release tablets) |
10,258,637 |
| Boehringer Ingelheim Pharms. Inc. v. Macleods Pharms. Ltd., 19-1864 (D. Del.) | Oct. 3, 2019 | Hon. Colm F. Connolly | Jardiance® (empagliflozin tablets) Glyxambi® (empagliflozin / linagliptin tablets) Synjardy® (empagliflozin / metformin tablets) |
10,258,637 |
| Boehringer Ingelheim Pharms. Inc. v. MSN Labs. Private Ltd., 19-1865 (D. Del.) | Oct. 3, 2019 | Hon. Colm F. Connolly | Jardiance® (empagliflozin tablets) Glyxambi® (empagliflozin / linagliptin tablets) Synjardy® XR (empagliflozin / metformin extended-release tablets) |
10,258,637 |
| Boehringer Ingelheim Pharms. Inc. v. Lupin Ltd., 19-1866 (D. Del.) | Oct. 3, 2019 | Hon. Colm F. Connolly | Synjardy® XR (empagliflozin / metformin extended-release tablets) | 9,949998 10,258637 |
| Bristol-Myers Squibb Co. v. Dr. Reddy’s Labs., Ltd., 19-18686 (D.N.J.) | Oct. 3, 2019 | Hon. Michael A. Shipp | Sprycel® (dasatinib tablets) | 7,491,725 8,680,103 |
| Boehringer Ingelheim Pharms. Inc. v. Alembic Pharms. Ltd., 19-1885 (D. Del.) | Oct. 7, 2019 | Hon. Colm F. Connolly | Jardiance® (empagliflozin tablets) Glyxambi® (empagliflozin / linagliptin tablets) Synjardy® (empagliflozin / metformin tablets) |
10,258,637 |
| Chiesi USA, Inc. v. Aurobindo Pharma USA, Inc., 19-18756 (D.N.J.) | Oct. 7, 2019 | Hon. Freda L. Wolfson | Cleviprex® (clevidipine injectable emulsion) | 8,658676 10,010537 |
| Mitsubishi Tanabe Pharma Corp. v. Dr. Reddy’s Labs., Inc., 19-18764 (D.N.J.) | Oct. 7, 2019 | Hon. Freda L. Wolfson | Invokamet® (canagliflozin / metformin HCl tablets) | 7,943,788 |
| Aclaris Therapeutics, Inc. v. Taro Pharms., Inc., 19-1910 (D. Del.) | Oct. 8, 2019 | Hon. Colm F. Connolly | Rhofade® (oxymetazoline HCl cream) | 7,812,049 8,420,688 8,815,929 9,974,773 10,335,391 |
| Celgene Corp. v. Zydus Pharms. (USA) Inc., 19-18806 (D.N.J.) | Oct. 8, 2019 | Hon. Michael A. Shipp | Otezla® (apremilast tablets) | 8,093,283 8,629,173 |
| Mylan API US LLC v. American Regent, Inc., 19-5675 (E.D.N.Y.) | Oct. 8, 2019 | Hon. Roslynn R. Mauskopf | Isosulfan Blue 1% injection | 9,353,050 |
| Otsuka Pharm. Co., Ltd. v. Zenara Pharma Private Ltd., 19-1938 (D. Del.) | Oct. 11, 2019 | Hon. Leonard P. Stark | Rexulti® (brexpiprazole tablets) | 7,888,362 8,349,840 8,618,109 9,839,637 10,307,419 |
| Otsuka Pharm. Co., Ltd. v. Ajanta Pharma Ltd., 19-1939 (D. Del.) | Oct. 11, 2019 | Hon. Leonard P. Stark | Rexulti® (brexpiprazole tablets) | 7,888,362 8,349,840 8,618,109 9,839,637 10,307,419 |
| Mitsubishi Tanabe Pharma Corp. v. MSN Labs. Private Ltd., 19-18958 (D.N.J.) | Oct. 14, 2019 | Hon. Freda L. Wolfson | Invokana® (canagliflozin tablets) Invokamet XR® (canagliflozin / metformin HCl extended-release tablets) |
7,943,788 |
| Otsuka Pharm. Co., Ltd. v. Amneal Pharms. LLC, 19-1952 (D. Del.) | Oct. 15, 2019 | Hon. Leonard P. Stark | Rexulti® (brexpiprazole tablets) | 7,888,362 8,349,840 8,618,109 9,839,637 10,307,419 |
| Otsuka Pharm. Co., Ltd. v. Hetero Labs Ltd., 19-1954 (D. Del.) | Oct. 15, 2019 | Hon. Leonard P. Stark | Rexulti® (brexpiprazole tablets) | 7,888,362 8,349,840 8,618,109 9,839,637 10,307,419 |
| Otsuka Pharm. Co., Ltd. v. Teva Pharms. USA, Inc., 19-1955 (D. Del.) | Oct. 15, 2019 | Hon. Leonard P. Stark | Rexulti® (brexpiprazole tablets) | 7,888,362 8,349,840 8,618,109 9,839,637 10,307,419 |
| Otsuka Pharm. Co., Ltd. v. Prinston Pharm. Inc., 19-1956 (D. Del.) | Oct. 15, 2019 | Hon. Leonard P. Stark | Rexulti® (brexpiprazole tablets) | 7,888,362 8,349,840 8,618,109 9,839,637 10,307,419 |
| Otsuka Pharm. Co., Ltd. v. Alkem Labs. Ltd., 19-1964 (D. Del.) | Oct. 16, 2019 | Hon. Leonard P. Stark | Rexulti® (brexpiprazole tablets) | 7,888,362 8,349,840 8,618,109 9,839,637 10,307,419 |
| Otsuka Pharm. Co., Ltd. v. Aurobindo Pharma Ltd., 19-1965 (D. Del.) | Oct. 16, 2019 | Hon. Leonard P. Stark | Rexulti® (brexpiprazole tablets) | 7,888,362 8,349,840 8,618,109 9,839,637 10,307,419 |
| Sanofi-Aventis U.S. LLC v. Shilpa Medicare Ltd., 19-1975 (D. Del.) | Oct. 17, 2019 | Hon. Maryellen Noreika | Aubagio® (teriflunomide tablets) | 6,794,410 9,186,346 |
| Otsuka Pharm. Co., Ltd. v. Unichem Labs. Ltd., 19-1977 (D. Del.) | Oct. 17, 2019 | Hon. Leonard P. Stark | Rexulti® (brexpiprazole tablets) | 7,888,362 8,349,840 8,618,109 9,839,637 10,307,419 |
| Novartis Pharms. Corp. v. Alkem Labs. Ltd., 19-1979 (D. Del.) | Oct. 17, 2019 | Hon. Leonard P. Stark | Entresto® (sacubitril / valsartan tablets) | 8,101,659 8,796,331 8,877,938 9,388,134 |
| AstraZeneca Pharms. LP v. Xiromed, LLC, 19-19081 (D.N.J.) | Oct. 17, 2019 | Hon. Renee Marie Bumb | Faslodex® (fulvestrant for injection) | 6,774,122 7,456,160 8,329,680 8,466,139 |
| Par Pharm., Inc. v. Fresenius Kabi USA, LLC, 19-1985 (D. Del.) | Oct. 18, 2019 | Hon. Colm F. Connolly | Vasostrict® (vasopressin for injection) | 9,375,478 9,687,526 9,744,209 9,750,785 9,937,223 |
| Otsuka Pharm. Co., Ltd. v. Accord Healthcare Inc., 19-1987 (D. Del.) | Oct. 18, 2019 | Hon. Leonard P. Stark | Rexulti® (brexpiprazole tablets) | 7,888,362 8,349,840 8,618,109 9,839,637 10,307,419 |
| Otsuka Pharm. Co., Ltd. v. Lupin Ltd., 19-1988 (D. Del.) | Oct. 18, 2019 | Hon. Leonard P. Stark | Rexulti® (brexpiprazole tablets) | 7,888,362 8,349,840 8,618,109 9,839,637 10,307,419 |
| Otsuka Pharm. Co., Ltd. v. Accord Healthcare Inc., 19-1072 (M.D.N.C.) | Oct. 18, 2019 | Hon. Thomas D. Schroeder | Rexulti® (brexpiprazole tablets) | 7,888,362 8,349,840 8,618,109 9,839,637 10,307,419 |
| Otsuka Pharm. Co., Ltd. v. Apotex Inc., 19-2006 (D. Del.) | Oct. 23, 2019 | Hon. Leonard P. Stark | Rexulti® (brexpiprazole tablets) | 10,307,419 |
| Otsuka Pharm. Co., Ltd. v. Alembic Pharms. Ltd., 19-2007 (D. Del.) | Oct. 23, 2019 | Hon. Leonard P. Stark | Rexulti® (brexpiprazole tablets) | 7,888,362 8,349,840 8,618,109 9,839,637 10,307,419 |
| Otsuka Pharm. Co., Ltd. v. Optimus Pharma Pvt. Ltd., 19-2008 (D. Del.) | Oct. 23, 2019 | Hon. Leonard P. Stark | Rexulti® (brexpiprazole tablets) | 7,888,362 8,349,840 8,618,109 9,839,637 10,307,419 |
| Otsuka Pharm. Co., Ltd. v. MSN Labs. Pvt. Ltd., 19-2009 (D. Del.) | Oct. 23, 2019 | Hon. Leonard P. Stark | Rexulti® (brexpiprazole tablets) | 7,888,362 8,349,840 8,618,109 9,839,637 10,307,419 |
| Novartis Pharms. Corp. v. Alembic Pharms. Ltd., 19-2021 (D. Del.) | Oct. 24, 2019 | Hon. Leonard P. Stark | Entresto® (sacubitril / valsartan tablets) | 8,101,659 8,796,331 8,877,938 9,388,134 |
| Otsuka Pharm. Co., Ltd. v. Zydus Pharms. (USA) Inc., 19-2024 (D. Del.) | Oct. 25, 2019 | Hon. Leonard P. Stark | Rexulti® (brexpiprazole tablets) | 7,888,362 8,349,840 8,618,109 9,839,637 10,307,419 |
| Novartis Pharms. Corp. v. Macleods Pharms. Ltd., 19-19345 (D.N.J.) | Oct. 25, 2019 | Hon. Mitchell S. Goldberg | Entresto® (sacubitril / valsartan tablets) | 8,101,659 8,877,938 9,388,134 |
| Otsuka Pharm. Co., Ltd. v. Zydus Pharms. (USA) Inc., 19-19394 (D.N.J.) | Oct. 25, 2019 | Hon. Freda L. Wolfson | Rexulti® (brexpiprazole tablets) | 7,888,362 8,349,840 8,618,109 9,839,637 10,307,419 |
| Exelixis, Inc. v. MSN Labs. Private Ltd., 19-2017 (D. Del.) | Oct. 29, 2019 | Hon. Richard G. Andrews | Cabometyx® (cabozantinib tablets) | 8,877,776 |
| Cydex Pharms., Inc. v. Lupin Ltd., 19-2043 (D. Del.) | Oct. 29, 2019 | Hon. Leonard P. Stark | Evomela® (Captisol®-enabled melphalan HCl for injection) | 9,200,088 9,493,582 |
| Genzyme Corp. v. Dr. Reddy’s Labs., Inc., 19-2045 (D. Del.) | Oct. 29, 2019 | Hon. Colm F. Connolly | Cerdelga® (eliglustat capsules) | 6,916802 7,253185 7,615573 |
| Novartis Pharms. Corp. v. Dr. Reddy’s Labs., Inc., 19-2053 (D. Del.) | Oct. 29, 2019 | Hon. Leonard P. Stark | Entresto® (sacubitril / valsartan tablets) | 8,101,659 8,796,331 8,877,938 9,388,134 |
| Otsuka Pharm. Co., Ltd. v. Macleods Pharms. Ltd., 19-2065 (D. Del.) | Oct. 30, 2019 | Hon. Leonard P. Stark | Rexulti® (brexpiprazole tablets) | 7,888,362 10,307,419 |
| Novartis Pharms. Corp. v. Mylan Pharms. Inc., 19-0201 (N.D.W.V.) | Oct. 30, 2019 | Hon. Irene M. Keeley | Entresto® (sacubitril / valsartan tablets) | 8,101,659 8,796,331 8,877,938 9,388,134 |
| Mylan Pharms. Inc. v. Merck Sharp & Dohme Corp., IPR2020-00040 (PTAB) | Oct. 30, 2019 | N/A | Januvia® (sitagliptin phosphate tablets) Janumet® (metformin HCL / sitagliptin phosphate tablets) Janumet® XR (metformin HCL / sitagliptin phosphate extended-release tablets) Juvisync® (simvastatin / sitagliptin phosphate tablets) Steglujan® (ertugliflozin / sitagliptin phosphate tablets) |
7,326,708 |
| Otsuka Pharm. Co., Ltd. v. Sandoz Inc., 19-2080 (D. Del.) | Nov. 1, 2019 | Hon. Leonard P. Stark | Rexulti® (brexpiprazole tablets) | 7,888,362 8,349,840 8,618,109 9,839,637 10,307,419 |
| Otsuka Pharm. Co., Ltd. v. Sandoz Inc., 19-3112 (D. Col.) | Nov. 1, 2019 | Hon. R. Brooke Jackson | Rexulti® (brexpiprazole tablets) | 7,888,362 8,349,840 8,618,109 9,839,637 10,307,419 |
| Viiv Healthcare Co. v. Cipla Ltd., 19-2085 (D. Del.) | Nov. 4, 2019 | Hon. Mitchell S. Goldberg | Dovato® (dolutegravir / lamivudine tablets) | 9,242,986 |
| Silvergate Pharms., Inc. v. Alkem Labs. Ltd., 19-2100 (D. Del.) | Nov. 5, 2019 | Hon. Leonard P. Stark | Epaned® (enalapril maleate for oral solution) | 9,669,008 9,808,442 10,039,745 10,154,987 |
| AstraZeneca AB v. Aurobindo Pharma USA Inc., 19-2113 (D. Del.) | Nov. 8, 2019 | Hon. Richard G. Andrews | Movantik® (naloxegol oxalate tablets) | 9,012,469 |
| IBSA Institut Biochimique SA v. Teva Pharms. USA, Inc., 19-2115 (D. Del.) | Nov. 8, 2019 | Hon. Richard G. Andrews | Tirosint® (levothyroxine sodium capsules) | 7,691,411 7,723,390 |
| Eisai R&D Management Co., Ltd. v. Shilpa Medicare Ltd., 19-19998 (D.N.J.) | Nov. 8, 2019 | Hon. Freda L. Wolfson | Lenvima® (lenvatinib mesylate capsules) | 10,259,791 |
| Aquestive Therapeutics, Inc. v. Biodelivery Sciences Int’l, Inc., 19-0505 (E.D.N.C.) | Nov. 11, 2019 | Hon. Terrence W. Boyle | Belbuca® (buprenorphine buccal film) | 8,765,167 |
| Fresenius Kabi USA, LLC v. Wockhardt USA LLC, 19-20383 (D.N.J.) | Nov. 15, 2019 | Hon. Claire C. Cecchi | Naropin® (ropivacaine HCl for injection) | 8,118,802 |
| Merz Pharms., LLC v. Annora Pharma Private Ltd., 19-2165 (D. Del.) | Nov. 20, 2019 | Hon. Richard G. Andrews | Cuvposa® (glycopyrrolate oral solution) | 7,638,552 7,816,396 |
| Merck Sharp & Dohme Corp. v. Accord Healthcare, Inc., 19-2192 (D. Del.) | Nov. 25, 2019 | Hon. Richard G. Andrews | Januvia® (sitagliptin phosphate tablets) | 7,326,708 |
| Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A. v. Aurobindo Pharma USA Inc., 19-2197 (D. Del.) | Nov. 25, 2019 | Hon. Richard G. Andrews | Desyrel® (trazodone HCl tablets) | 8,133,893 |
| Vanda Pharms. Inc. v. Teva Pharms. USA, Inc., 19-2202 (D. Del.) | Nov. 26, 2019 | Hon. Colm F. Connolly | Hetlioz® (tasimelteon capsules) | 10,376,487 |
| Cipla Ltd. v. Novartis AG, 19-20810 (D.N.J.) | Nov. 26, 2019 | Hon. Stanley R. Chesler | Jadenu® (deferasirox tablets) | 9,283,209 |
| Biogen Int’l GmbH v. Cipla Ltd., 19-2210 (D. Del.) | Nov. 27, 2019 | Hon. Leonard P. Stark | Tecfidera® (dimethyl fumarate delayed-release capsules) | 7,619,001 |
| Alembic Pharms. Ltd. v. Novartis Pharms. Corp. 19-20890 (D.N.J.) | Nov. 27, 2019 | Hon. Stanley R. Chesler | Jadenu® (deferasirox tablets) | 9,283,209 |
| Amneal Pharms. LLC v. Cubist Pharms. LLC, IPR2020-00193 (PTAB) | Nov. 27, 2019 | N/A | Cubicin RF® (daptomycin for injection) | 9,138,456 |
| Takeda Pharms. U.S.A., Inc. v. Mylan Pharms. Inc., 19-2216 (D. Del.) | Dec. 2, 2019 | Hon. Richard G. Andrews | Colcrys® (colchicine tablets) | 7,906,519 7,935,731 8,093,297 8,093,298 7,964,648 |
| Medicure Int’l, Inc. v. Nexus Pharms., Inc., 19-7979 (N.D. Ill.) | Dec. 5, 2019 | Hon. Sharon Johnson Coleman | Aggrastat® (tirofiban HCl for injection) | 6,770,660 |
| Chiesi USA Inc. v. Gland Pharma Ltd., 19-21204 (D.N.J.) | Dec. 9, 2019 | Hon. Madeline Cox Arleo | Kengreal® (cangrelor for injection) | 6,130,208 8,680,052 9,427,448 9,439,921 9,700,575 9,925,265 10,039,780 |
| Millennium Pharms., Inc. v. Fresenius Kabi USA, LLC, 19-2252 (D. Del.) | Dec. 10, 2019 | Hon. Colm F. Connolly | Velcade® (bortezomib for injection) | 6,713,446 6,958,319 |
| Zydus Pharms. (USA) Inc. v. Novartis Pharms. Corp., 19-21259 (D.N.J.) | Dec. 10, 2019 | Hon. Stanley R. Chesler | Jadenu® (deferasirox tablets) | 9,283,209 |
| Corcept Therapeutics, Inc. v. Teva Pharms USA, Inc., 19-21384 (D.N.J.) | Dec. 13, 2019 | Hon. Susan D. Wigenton | Korlym® (mifepristone tablets) | 10,500,216 |
| Taiho Pharm. Co., Ltd. v. Eugia Pharma Specialities Ltd., 19-2309 (D. Del.) | Dec. 19, 2019 | Hon. Colm F. Connolly | Lonsurf® (trifluridine / tipiracil tablets | RE46,284 10,138,223 |
| Janssen Pharms., Inc. v. Pharmascience Inc., 19-21590 (D.N.J.) | Dec. 19, 2019 | Hon. Claire C. Cecchi | Invega Sustenna® (paliperidone palmitate extended-release injectable suspension) | 9,439,906 |
| Mylan Institutional LLC v. Novo Nordisk A/S, IPR2020-00324 (PTAB) | Dec. 19, 2019 | N/A | Victoza® (liraglutide recombinant for injection) Saxenda® (liraglutide recombinant for injection) Ozempic® (semaglutide) |
8,114,833 |
| Janssen Pharms., Inc. v. Pharmascience Inc., 19-2313 (D. Del.) | Dec. 20, 2019 | Hon. Colm F. Connolly | Invega Sustenna® (paliperidone palmitate extended-release injectable suspension) | 9,439,906 |
| Allergan USA, Inc. v. Sun Pharm. Indus. Ltd., 19-2317 (D. Del.) | Dec. 20, 2019 | Hon. Richard G. Andrews | Vraylar® (cariprazine capsules) | 7,737,142 7,943,621 |
| Taiho Pharm. Co., Ltd. v. Accord Healthcare Inc., 19-2321 (D. Del.) | Dec. 20, 2019 | Hon. Colm F. Connolly | Lonsurf® (trifluridine / tipiracil tablets | RE46,284 9,527,833 10,457,666 |
| Allergan Sales, LLC v. Torrent Pharms. Ltd., 19-21709 (D.N.J.) | Dec. 20, 2019 | Hon. Esther Salas | Fetzima® (levomilnacipran HCl extended-release capsules) | 8,481,598 8,865,937 RE43,879 |
| Sun Pharm. Indus. Ltd. v. Novartis Pharms. Corp., 19-21733 (D.N.J.) | Dec. 20, 2019 | Hon. Claire C. Cecchi | Ciprodex® (ciprofloxacin / dexamethasone otic suspension) | 9,402,805 9,345,714 9,149,486 8,846,650 |
| Taiho Pharm. Co., Ltd. v. MSN Labs. Private Ltd., 19-2342 (D. Del.) | Dec. 23, 2019 | Hon. Colm F. Connolly | Lonsurf® (trifluridine / tipiracil tablets | RE46,284 9,527,833 |
| Taiho Pharm. Co., Ltd. v. Accord Healthcare Inc., 19-1251 (M.D.N.C.) | Dec. 23, 2019 | Hon. William L. Osteen, Jr. | Lonsurf® (trifluridine / tipiracil tablets | RE46,284 9,527,833 10,457,666 |
| Eisai R&D Management Co., Ltd. v. Sun Pharm. Indus. Ltd., 19-21857 (D.N.J.) | Dec. 23, 2019 | Hon. Freda L. Wolfson | Lenvima® (lenvatinib mesylate capsules) | 10,259,791 10,407,393 |
| Ayla Pharma LLC v. Alcon Research, LLC, IPR2020-00295 (PTAB) | Dec. 24, 2019 | N/A | Pazeo® (olopatadine HCl ophthalmic drops) | 9,533,053 |
| Taiho Pharm. Co., Ltd. v. Natco Pharma Ltd., 19-2368 (D. Del.) | Dec. 30, 2019 | Hon. Colm F. Connolly | Lonsurf® (trifluridine / tipiracil tablets | RE46,284 9,527,833 10,457,666 |
| Vanda Pharms. Inc. v. Apotex Inc., 19-2375 (D. Del.) | Dec. 30, 2019 | Hon. Colm F. Connolly | Hetlioz® (tasimelteon capsules) | 10,376,487 |
| Actelion Pharms. Ltd. v. Zydus Pharms. (USA), Inc., 19-22193 (D.N.J.) | Dec. 31, 2019 | Hon. Brian R. Martinotti | Tracleer® (bosentan tablets) | 8,309,126 |
| Celgene Corp. v. Mylan Pharms. Inc., 19-22231 (D.N.J.) | Dec. 31, 2019 | Hon. Susan D. Wigenton | Revlimid® (lenalidomide capsules) | 7,189,740 7,465,800 7,855,217 7,968,569 8,404,717 8,530,498 8,648,095 9,056,120 9,101,621 9,101,622 |
GENERICally Speaking Winter 2020
GENERICally Speaking Hatch Waxman Bulletin Related Professionals
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