New ANDA Cases

Winter 2020

Robins Kaplan GENERICally Speaking: A Hatch-Waxman Litigation Bulletin
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
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