New ANDA Cases

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

Fall 2020

Robins Kaplan GENERICally Speaking: A Hatch-Waxman Litigation Bulletin

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).
Avion Pharms., LLC v. Granules Pharms., Inc., 20-0898 (D. Del.) July 1, 2020 Hon. Leonard P. Stark Gloperba®
(colchicine
oral solution)
9,907,751
10,226,423
Horizon Medicines LLC v. Teva Pharms. USA, Inc., 20-8188 (D.N.J.) July 2, 2020 Hon. John M. Vazquez Duexis®
(ibuprofen / famotidine tablets)
8,067,033
8,067,451
8,309,127
8,318,202
8,449,910
8,501,228
Vifor Fresenius Medical Care Renal Pharma Ltd. v. Lupin Atlantis Holdings SA, 20-0911 (D. Del.) July 6, 2020 Hon. Maryellen Noreika Velphoro®
(sucroferric
oxyhydroxide
chewable tablets)
10,682,376
10,695,367
Arbor Pharms., LLC v. Lupin Ltd., 20-0922 (D. Del.) July 8, 2020 Hon. Maryellen Noreika Edarbi® (azilsartan medoxomil tablets) 7,157,584
7,572,920
9,066,936
Allergan, Inc. v. Gland Pharma Ltd., 20-0932 (D. Del.) July 9, 2020 Hon. Colm F. Connolly Lastacaft® (alcaftadine ophthalmic solution) 8,664,215
10,617,695
Celgene Corp. v. Lupin Ltd., 20-8570 (D.N.J.) July 9, 2020 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
Allergan, Inc. v. Gland Pharma Ltd., 20-4094 (N.D. Ill.) July 10, 2020 Hon. Joan B. Gottschall Lastacaft® (alcaftadine ophthalmic solution) 8,664,215
10,617,695
TherapeuticsMD, Inc. v. Teva Pharms. USA, Inc., 20-8809 (D.N.J.) July 13, 2020 Hon. Brian R. Martinotti Imvexxy®
(estradiol vaginal inserts)
10,537,581
Amarin Pharma, Inc. v. Hikma Pharms. USA, Inc., 20-0421 (D. Nev) July 13, 2020 Hon. Miranda M. Du Vascepa®
(icosapent ethyl capsules)
8,293,728
8,318,715
8,357,677
8,367,652
8,377,920
8,415,335
8,426,399
8,440,650
8,518,929
8,524,698
8,546,372
8,617,594
Merck Sharp & Dohme Corp. v. Aurobindo Pharma Ltd., 20-0949 (D. Del.) July 15, 2020 Hon. Richard G. Andrews Januvia® (sitagliptin phosphate tablets) 7,326,708
Takeda Pharm. Co. Ltd. v. Norwich Pharms., Inc., 20-8966 (D.N.J.) July 15, 2020 Hon. Stanley R. Chesler Vyvanse® (lisdexamfetamine dimesylate capsules) 7,105,486
7,223,735
7,655,630
7,659,253
7,659,254
7,662,787
7,662,788
7,671,030
7,671,031
7,674,774
7,678,770
7,678,771
7,687,466
7,687,467
7,700,561
7,713,936
7,718,619
7,723,305
Takeda Pharm. Co. Ltd. v. Norwich Pharms., Inc., 20-0953 (D. Del.) July 16, 2020 Hon. Leonard P. Stark Vyvanse® (lisdexamfetamine dimesylate capsules) 7,105,486
7,223,735
7,655,630
7,659,253
7,659,254
7,662,787
7,662,788
7,671,030
7,671,031
7,674,774
7,678,770
7,678,771
7,687,466
7,687,467
7,700,561
7,713,936
7,718,619
7,723,305
Cephalon, Inc. v. Aurobindo Pharma, Ltd., 20-0962 (D. Del.) July 17, 2020 Hon. Colm F. Connolly Treanda® (bendamustine HCL for injection) 8,436,190
8,609,863
8,791,270
8,895,756
AbbVie Inc. v. Dr. Reddy’s Labs., Ltd., 20-0968 (D. Del.) July 21, 2020 Hon. Leonard P. Stark Venclexta®
(venetoclax tablets)
8,546,399
9,174,982
8,722,657
9,539,251
Almirall, LLC v. Perrigo UK Finco Ltd. Partnership, 20-0975 (D. Del.) July 22, 2020 Hon. Gerald J. Pappert Aczone®
(dapsone gel)
9,517,219
ViiV Healthcare Co. v. Cipla Ltd., 20-0977 (D. Del.) July 22, 2020 Hon. Mitchell S. Goldberg Juluca® (dolutegravir sodium / rilpivirine HCl tablets) 9,242,986
10,426,780
AbbVie Inc. v. Dr. Reddy’s Labs., Inc., 20-9292 (D.N.J.) July 22, 2020 Hon. Michael A. Shipp Venclexta®
(venetoclax tablets)
8,546,399
9,174,982
8,722,657
9,539,251
Pfizer Inc. v. Novo Nordisk A/S, IPR2020-01252 (PTAB) July 22, 2020 N/A Victoza® (liraglutide recombinant for injection) Saxenda® (liraglutide recombinant for injection) Ozempic® (semaglutide for injection) 8,114,833
Janssen Products, L.P. v. Evenus Pharms. Labs. Inc., 20-9369 (D.N.J.) July 23, 2020 Hon. Freda L. Wolfson Yondelis® (trabectedin for injection) 8,895,557
ACADIA Pharms. Inc. v. Aurobindo Pharma Ltd., 20-0985 (D. Del.) July 24, 2020 Hon. Richard G. Andrews Nuplazid® (pimavanserin tartrate capsules) 7,601,740
7,732,615
10,449,185
10,646,480
ACADIA Pharms. Inc. v. Teva Pharms. USA, Inc., 20-0986 (D. Del.) July 24, 2020 Hon. Richard G. Andrews Nuplazid® (pimavanserin tartrate capsules) 7,601,740
7,732,615
10,449,185
10,646,480
UCB, Inc. v. Annora Pharma Private Ltd., 20-0987 (D. Del.) July 24, 2020 Hon. Colm F. Connolly Briviact®
(brivaracetam tablets)
6,784,197
6,911,461
8,492,416
Vertex Pharms. Inc. v. Sun Pharm. Indus. Ltd., 20-0988 (D. Del.) July 24, 2020 Hon. Richard G. Andrews Kalydeco®
(ivacaftor tablets)
10,646,481
AbbVie Inc. v. Alembic Pharms. Ltd., 20-1009 (D. Del.) July 28, 2020 Hon. Leonard P. Stark Venclexta®
(venetoclax tablets)
8,546,399
9,174,982
8,722,657
9,539,251
ACADIA Pharms. Inc. v. Zydus Pharms. (USA) Inc., 20-1021 (D. Del.) July 30, 2020 Hon. Richard G. Andrews Nuplazid® (pimavanserin tartrate capsules) 7,601,740
7,732,615
10,517,860
10,449,185
10,646,480
ACADIA Pharms. Inc. v. Hetero Labs Ltd., 20-1022 (D. Del.) July 30, 2020 Hon. Richard G. Andrews Nuplazid® (pimavanserin tartrate capsules) 7,601,740
10,449,185
10,646,480
ACADIA Pharms. Inc. v. MSN Labs. Private Ltd., 20-1029 (D. Del.) July 30, 2020 Hon. Richard G. Andrews Nuplazid® (pimavanserin tartrate capsules) 7,732,615
10,646,480
Teva Branded Pharm. Products R&D, Inc. v. Cipla Ltd., 20-10172 (D.N.J.) Aug. 7, 2020 Hon. Madeline Cox Arleo Qvar® (beclomethasone dipropionate metered aerosol) 9,463,289
9,808,587
10,022,509
10,022,510
10,086,156
10,561,808
Allergan Pharms. Int’l Ltd. v. Sun Pharm. Indus. Ltd., 20-10176 (D.N.J.) Aug. 7, 2020 Hon. Susan D. Wigenton Asacol® (mesalamine delayed-release tablets) 9,089,492
Biocon Pharma Ltd. v. Novartis Pharms. Corp., IPR2020-01263 (PTAB) Aug. 7, 2020 N/A Entresto® (sacubitril / valsartan tablets)) 8,101,659
Horizon Orphan LLC v. Lupin Ltd., 20-10339 (D.N.J.) Aug. 11, 2020 Hon. Madeline Cox Arleo Procysbi®
(cysteamine bitartrate delayed-release
capsules)
8,026,284
9,192,590
9,198,882
9,925,156
9,925,157
9,925,158
9,173,851
9,233,077
10,143,665
10,328,037
10,548,859
Bayer Intellectual Property GmbH v. Dr. Reddy’s Labs., Inc., 20-10378 (D.N.J.) Aug. 12, 2020 Hon. Madeline Cox Arleo Xarelto® (rivaroxaban tablets) 9,539,218
Currax Pharms. LLC v. MSN Labs. Private Ltd., 20-1064 (D. Del.) Aug. 13, 2020 Hon. Richard G. Andrews Silenor® (doxepin HCl tablets) 7,915,307
9,532,971
9,572,814
9,907,780
10,548,871
10,653,660
Merck Sharp & Dohme Corp. v. Aurobindo Pharma USA Inc., 20-10444 (D.N.J.) Aug. 13, 2020 Hon. Freda L. Wolfson Noxafil® (posaconazole for injection) 9,023,790
9,358,297
Adamas Pharma, LLC v. Zydus Worlwide DMCC, 20-10463 (D.N.J.) Aug. 13, 2020 Hon. Brian R. Martinotti Gocovri® (amantadine HCl extended-release capsules) 8,389,578
8,796,337
8,889,740
8,895,614
8,895,615
8,895,616
8,895,617
8,895,618
8,741,343
9,867,791
9,867,792
9,867,793
9,877,933
10,154,971
10,646,456
Azurity Pharms., Inc. v. Alkem Labs Ltd., 20-1094 (D. Del.) Aug. 20, 2020 Hon. Leonard P. Stark Firvanq® (vancomycin HCl oral solution) 10,493,028
Merck Sharp & Dohme Corp. v. Aurobindo Pharma Ltd., 20-1099 (D. Del.) Aug. 21, 2020 Hon. Richard G. Andrews Janumet® (metformin HCl / sitagliptin phosphate tablets) 7,326,708
Vanda Pharms. Inc. v. Teva Pharms. USA, Inc., 20-1104 (D. Del.) Aug. 21, 2020 Hon. Colm F. Connolly Hetlioz®
(tasimelteon capsules)
10,610,510
10,610,511
Intercept Pharms., Inc. v. Apotex Inc., 20-1105 (D. Del.) Aug. 21, 2020 Hon. Maryellen Noreika Ocaliva®
(obeticholic acid tablets)
9,238,673
10,047,117
10,052,337
10,174,073
Bausch Health Ireland Ltd. v. Lupin Ltd., 20-11039 (D.N.J.) Aug. 21, 2020 Hon. Renee Marie Bumb Plenvu® (polyethylene glycol / sodium ascorbate / sodium sulfate / ascorbic acid / sodium chloride / potassium chloride oral solution) 10,646,512
TherapeuticsMD, Inc. v. Teva Pharms. USA, Inc., 20-11087 (D.N.J.) Aug. 21, 2020 Hon. Brian M. Martinotti Imvexxy® (estradiol vaginal inserts) 10,668,082
Assertio Therapeutics, Inc. v. Patrin Pharma, Inc., 20-5055 (N.D. Ill.) Aug. 27, 2020 Hon. Charles P. Kocoras Cambia® (diclofenac potassium powder for oral solution) 7,759,394
8,097,651
8,927,604
9,827,197
Boehringer Ingelheim Pharms. Inc. v. Sun Pharm. Indus. Ltd., 20-1153 (D. Del.) Aug. 28, 2020 Hon. Colm F. Connolly Trijardy XR® (empagliflozin / linagliptin / metformin extended-release tablets) 8,551,957
9,155,705
9,415,016
9,949,998
10,022,379
10,258,637
10,406,172
10,596,120
Intercept Pharms., Inc. v. Amneal Pharms. LLC, 20-1154 (D. Del.) Aug. 28, 2020 Hon. Maryellen Noreika Ocaliva® (obeticholic acid tablets) 9,238,673
10,047,117
10,052,337
10,174,073
Intercept Pharms., Inc. v. Lupin Ltd., 20-1155 (D. Del.) Aug. 28, 2020 Hon. Maryellen Noreika Ocaliva®
(obeticholic acid tablets)
7,138,390
9,238,673
10,047,117
10,052,337
10,174,073
Bausch Health Ireland Ltd. v. Perrigo Israel Pharms. Ltd., 20-11807 (D.N.J.) Aug. 28, 2020 Hon. Stanley R. Chesler Duobrii® (halobetasol propionate / tazarotene lotion) 8,809,307
10,478,502
10,251,895
10,426,787
Biogen MA Inc. v. Sun Pharm. Indus. Ltd., 20-1159 (D. Del.) Aug. 31, 2020 Hon. Maryellen Noreika Tecfidera® (dimethyl fumarate delayed-release capsules) 8,399,514
AstraZeneca AB v. Macleods Pharms. Ltd., 20-1180 (D. Del.) Sept. 3, 2020 Hon. Richard G. Andrews Brilinta®
(ticagrelor tablets)
10,300,065
Astellas US LLC v. Meitheal Pharms., Inc., 20-1182 (D. Del.) Sept. 4, 2020 Hon. Colm F. Connolly Lexiscan®
(regadenoson for injection)
8,106,183
RE47,301
8,524,883
Fresenius Kabi USA, LLC v. Gland Pharma Ltd., 20-12347 (D. N.J.) Sept. 4, 2020 Hon. Freda L. Wolfson Naropin®
(ropivacaine HCl for injection)
8,118,802
Alkermes, Inc. v. Teva Pharm. Indus. Ltd., 20-12470 (D.N.J.) Sept. 9, 2020 Hon. Madeline Cox Arleo Vivitrol® (extended-release naltrexone for injection) 7,919,499
Intercept Pharms., Inc. v. MSN Labs. Private Ltd., 20-1214 (D. Del.) Sept. 10, 2020 Hon. Maryellen Noreika Ocaliva® (obeticholic acid tablets) 7,138,390
9,238,673
10,047,117
10,052,337
10,174,073
Intercept Pharms., Inc. v. Optimus Pharma Pvt. Ltd., 20-1215 (D. Del.) Sept. 10, 2020 Hon. Maryellen Noreika Ocaliva® (obeticholic acid tablets) 7,138,390
9,238,673
10,047,117
10,052,337
10,174,073
Orexo AB v. Sun Pharm. Indus. Ltd., 20-12588 (D.N.J.) Sept. 11, 2020 Hon. Brian R. Martinotti Zubsolv® (buprenorphine / naloxone sublingual tablets) 8,470,361 
8,658,198
8,940,330
9,259,421
9,439,900
Merck Sharp & Dohme Corp. v. Unichem Labs. Ltd., 20-1227 (D. Del.) Sept. 15, 2020 Hon. Richard G. Andrews Januvia® (sitagliptin phosphate tablets) 7,326,708
Silvergate Pharms., Inc. v. Amneal Pharms. LLC, 20-1255 (D. Del.) Sept. 18, 2020 Hon. Leonard P. Stark Epaned® (enalapril maleate oral solution) 10,772,868
Silvergate Pharms., Inc. v. Bionpharma Inc., 20-1256 (D. Del.) Sept. 18, 2020 Hon. Leonard P. Stark Epaned® (enalapril maleate oral solution) 10,772,868
Kitov Pharma Ltd. v. Lupin Ltd., 20-12849 (D.N.J.) Sept. 18, 2020 Hon. Claire C. Cecchi Consensi® (amlodipine besylate / celecoxib tablets) 10,350,171
9,408,837
Eton Pharms., Inc. v. Exela Pharma Sciences, LLC, PGR2020-00086 (PTAB) Sept. 21, 2020 N/A Elcys® (cysteine HCl for injection) Nouress® (cysteine HCl for injection) 10,653,719
Janssen Pharms., Inc. v. Mylan Labs. Ltd.,
20-13103 (D.N.J.)
Sept. 23, 2020 Hon. Brian R. Martinotti Trinza® (paliperidone palmitate extended-release injectable suspension) 10,143,693
Otsuka Pharm. Co., Ltd. v. Alkem Labs. Ltd.,
20-1286 (D. Del.)
Sept. 24, 2020 Hon. Leonard P. Stark Rexulti®
(brexipiprazole tablets)
RE48,059
Otsuka Pharm. Co., Ltd. v. Accord Healthcare Inc.,
20-1287 (D. Del.)
Sept. 24, 2020 Hon. Leonard P. Stark Rexulti®
(brexipiprazole tablets)
RE48,059
Otsuka Pharm. Co., Ltd. v. Accord Healthcare Inc.,
20-0878 (M.D.N.C.)
Sept. 24, 2020 Hon. Thomas D. Schroeder Rexulti®
(brexipiprazole tablets)
RE48,059
Otsuka Pharm. Co., Ltd. v. Unichem Labs. Ltd.,
20-1295 (D. Del.)
Sept. 25, 2020 Hon. Leonard P. Stark Rexulti®
(brexipiprazole tablets)
RE48,059
Otsuka Pharm. Co., Ltd. v. Lupin Ltd.,
20-1296 (D. Del.)
Sept. 25, 2020 Hon. Leonard P. Stark Rexulti®
(brexipiprazole tablets)
RE48,059
Otsuka Pharm. Co., Ltd. v. Amneal Pharms. LLC,
20-1297 (D. Del.)
Sept. 25, 2020 Hon. Leonard P. Stark Rexulti®
(brexipiprazole tablets)
RE48,059

Oren D. Langer

Partner

Assistant Managing Partner, New York Office
Member of Executive Board

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