New ANDA Cases - Fall 2020

Robins Kaplan LLP

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

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

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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