New ANDA Cases - Spring 2021

Robins Kaplan LLP

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).
Covis Pharma GmbH v. Eugia Pharma Specialties Ltd., 21-0003 (D. Del.) Jan. 4, 2021 Hon. Colm F. Connolly MakenaÒ Auto-Injector (hydroxy-progesterone caproate) 9,844,558
10,471,075
Liquidia Technologies, Inc. v. United Therapeutics Corp., IPR2021-00406 (PTAB) Jan. 7, 2021 N/A TyvasoÒ (treprostinil solution) 10,716,793
Pfizer Inc. v. Aurobindo Pharma Ltd., 21-0022 (D. Del.) Jan. 11, 2021 Hon. Leonard P. Stark Xeljanz® (tofacitinib tablets) 6,965,027
RE41,783
Celgene Corp. v. Aurobindo Pharma Ltd., 21-0624 (D.N.J.) Jan. 12, 2021 Hon. Susan D. Wigenton Revlimid® (lenalidomide capsules) 7,977,357
8,193,219
8,431,598
Pfizer Inc. v. Aizant Drug Research Solutions Pvt. Ltd., 21-0034 (D. Del.) Jan. 13, 2021 Hon. Colm F. Connolly Ibrance® (palbociclib capsules) 10,723,730
Intercept Pharms., Inc. v. Dr. Reddy’s Labs., Inc., 21-0035 (D. Del.) Jan. 13, 2021 Hon. Maryellen Noreika Ocaliva® (obeticholic acid tablets) RE 48,286
9,238,673
10,047,117
10,052,337
10,174,073
10,751,349
10,758,549
Pfizer Inc. v. Aizant Drug Research Solutions Pvt. Ltd., 21-0686 (D.N.J.) Jan. 13, 2021 Hon. Renee Marie Bumb Ibrance® (palbociclib capsules) 10,723,730
Mitsubishi Tanabe Pharma Corp. v. Macleods Pharms., Ltd., 21-0697 (D.N.J.) Jan. 13, 2021 Hon. Renee Marie Bumb Invokamet® XR (canagliflozin / metformin extended-release tablets) 7,943,582
8,513,202
Amgen Inc. v. Alembic Pharms. Ltd., 21-0061 (D. Del.) Jan. 20, 2021 Hon. Colm F. Connolly Corlanor® (ivabradine tablets) 7,361,649
7,361,650
7,867,996
7,879,842
Pfizer Inc. v. Natco Pharma, Inc., 21-0078 (D. Del.) Jan. 26, 2021 Hon. Colm F. Connolly Ibrance® (palbociclib capsules) 10,723,730
Vanda Pharms. Inc. v. Teva Pharms. USA, Inc., 21-0121 (D. Del.) Jan. 29, 2021 Hon. Colm F. Connolly Hetlioz® (tasimelteon capsules) 10,829,465
Boehringer Ingelheim Pharms., Inc. v. Qilu Pharm. Co., Ltd., 21-1732 (D.N.J.) Feb. 2, 2021 Hon. Michael A. Shipp Gilotrif® (afatinib tablets) RE43,431
8,426,586
10,004,743
Celgene Corp. v. Sun Pharma Global FZE, 21-1734 (D.N.J.) Feb. 2, 2021 Hon. Susan D. Wigenton Revlimid® (lenalidomide capsules) 8,530,498
8,648,095
9,101,621
9,101,622
Pfizer Inc. v. MSN Pharms. Inc., 21-0139 (D. Del.) Feb. 3, 2021 Hon. Colm F. Connolly Ibrance® (palbociclib capsules) 10,723,730
Boehringer Ingelheim Pharms., Inc. v. Qilu Pharm. Co., Ltd., 21-0564 (E.D. Pa.) Feb. 5, 2021 Hon. Joshua D. Wolson Gilotrif® (afatinib tablets) RE43,431
8,426,586
10,004,743
Celgene Corp. v. Dr. Reddy’s Labs., Ltd., 21-2111 (D.N.J.) Feb. 8, 2021 Hon. Esther Salas PomalystÒ (pomalidomide capsules) 10,093,647
10,093,648
10,093,649
Merck Sharp & Dohme Corp. v. Inventia Healthcare Ltd., 21-0182 (D. Del.) Feb. 10, 2021 Hon. Richard G. Andrews Janumet® (metformin HCl / sitagliptin phosphate tablets) 7,326,708
Bial – Portela & CA S.A. v. Alkem Labs. Ltd., 21-0186 (D. Del.) Feb. 10, 2021 Hon. Colm F. Connolly AptiomÒ (eslicarbazepine acetate tablets) 10,912,781
Bial – Portela & CA S.A. v. Apotex Inc., 21-0187 (D. Del.) Feb. 10, 2021 Hon. Colm F. Connolly AptiomÒ (eslicarbazepine acetate tablets) 10,912,781
Bial – Portela & CA S.A. v. Dr. Reddy’s Labs., Ltd., 21-0188 (D. Del.) Feb. 10, 2021 Hon. Colm F. Connolly AptiomÒ (eslicarbazepine acetate tablets) 10,912,781
Bial – Portela & CA S.A. v. Jubilant Pharmova Ltd., 21-0189 (D. Del.) Feb. 10, 2021 Hon. Colm F. Connolly AptiomÒ (eslicarbazepine acetate tablets) 10,912,781
Bial – Portela & CA S.A. v. Torrent Pharms. Ltd., 21-0190 (D. Del.) Feb. 10, 2021 Hon. Colm F. Connolly AptiomÒ (eslicarbazepine acetate tablets) 10,912,781
Janssen Pharms., Inc. v. Macleods Pharms., Ltd., 21-2309 (D.N.J.) Feb. 10, 2021 Hon. Renee Marie Bumb InvokanaÒ (canagliflozin tablets) 10,617,668
Silvergate Pharms., Inc. v. Annora Pharma Private Ltd., 21-0196 (D. Del.) Feb. 11, 2021 Hon. Leonard P. Stark EpanedÒ (enalapril maleate oral solution) 10,772,868
10,786,482
10,799,476
Pfizer Inc. v. Zydus Pharms. (USA) Inc., 21-0214 (D. Del.) Feb. 16, 2021 Hon. Leonard P. Stark XeljanzÒ XR (tofacitinib extended-release tablets) RE41,783
6,965,027
Custopharm, Inc. v. Fresenius Kabi USA, LLC, 21-0148 (W.D. Tex.) Feb. 16, 2021 Hon. Alan D. Albright Levothyroxine sodium for injection 9,782,376
10,398,669
Hikma Pharms. USA Inc. v. Aurobindo Pharma Ltd., 21-0228 (D. Del.) Feb. 18, 2021 Hon. Colm F. Connolly Mitigare® (colchicine capsules) 8,927,607
9,399,036
9,555,029
9,675,613
9,789,108
Novartis Pharms. Corp. v. Lupin Atlantis Holdings, S.A., 21-0229 (D. Del.) Feb. 18, 2021 Hon. Leonard P. Stark Entresto® (sacubitril / valsartan tablets) 8,101,659
8,796,331
8,877,938
9,388,134
Vanda Pharms. Inc. v. Apotex Inc., 21-0282 (D. Del.) Feb. 24, 2021 Hon. Colm F. Connolly Hetlioz® (tasimelteon capsules) 10,829,465
Vanda Pharms. Inc. v. MSN Pharms. Inc., 21-0283 (D. Del.) Feb. 24, 2021 Hon. Colm F. Connolly Hetlioz® (tasimelteon capsules) 10,829,465
Pfizer Inc. v. Synthon Pharms., Inc., 21-0284 (D. Del.) Feb. 24, 2021 Hon. Colm F. Connolly Ibrance® (palbociclib capsules) 6,936,612
RE47,739
7,456,168
10,723,730
Pfizer Inc. v. Sun Pharm. Indus., Ltd., 21-0285 (D. Del.) Feb. 24, 2021 Hon. Colm F. Connolly Ibrance® (palbociclib capsules) 10,723,730
Pfizer Inc. v. Synthon Pharms., Inc., 21-0157 (M.D.N.C.) Feb. 25, 2021 Hon. Loretta C. Biggs Ibrance® (palbociclib capsules) 6,936,612
RE47,739
7,456,168
10,723,730
Bayer Pharma AG v. Lupin Ltd., 21-0314 (D. Del.) Mar. 1, 2021 Hon. Richard G. Andrews Xarelto® (rivaroxaban tablets) 10,828,310
Merck Sharp & Dohme Corp. v. Zydus Worldwide DMCC, 21-0315 (D. Del.) Mar. 1, 2021 Hon. Richard G. Andrews Januvia® (sitagliptin phosphate tablets) 7,326,708
Otsuka Pharm. Co., Ltd. v. Macleods Pharms. Ltd., 21-0316 (D. Del.) Mar. 1, 2021 Hon. Leonard P. Stark Rexulti® (brexpiprazole tablets) RE48,059
Astellas US LLC v. Mylan Pharms. Inc., 21-0032 (N.D.W.V.) Mar. 4, 2021 Hon. Thomas S. Kleeh Lexiscan® (regadenoson for injection) 8,106,183
RE47,301
8,524,883
Boehringer Ingelheim Pharms. Inc. v. Sun Pharm. Indus. Ltd., 21-0356 (D. Del.) Mar. 9, 2021 Hon. Colm F. Connolly Synjardy XR® (empagliflozin / metformin extended-release tablets) 7,579,449
9,949,998
10,258,637
10,596,120
Pfizer Inc. v. Micro Labs, Ltd., 21-0361 (D. Del.) Mar. 11, 2021 Hon. Leonard P. Stark Xeljanz® (tofacitinib tablets) RE41,783
6,965,027
Corcept Therapeutics, Inc. v. Hikma Pharms. USA Inc., 21-5034 (D.N.J.) Mar. 12, 2021 Hon. Susan D. Wigenton Korlym® (mifepristone tablets) 10,195,214
10,500,216
10,842,800
10,842,801
Biogen Inc. v. Teva Pharms. Development Inc., 21-0389 (D. Del.) Mar. 17, 2021 Hon. Leonard P. Stark Vumerity® (diroximel fumarate delayed-release capsules) 8,669,281
9,090,558
10,080,733
Astellas Pharma Inc. v. Aurobindo Pharma Ltd., 21-0425 (D. Del.) Mar. 24, 2021 Hon. Joseph F. Bataillon Myrbetriq® (mirabegron extended-release tablets) 10,842,780
Azurity Pharms., Inc. v. ANI Pharms., Inc., 21-0796 (D. Minn.) Mar. 24, 2021 Hon. John R. Tunheim Firvanq® (vancomycin HCl oral solution) 10,688,046
Aziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A. v. CrossMedica S.A., 21-0455 (D. Del.) Mar. 26, 2021 Hon. Richard G. Andrews Desyrel® (trazodone HCl tablets) 8,133,893
Supernus Pharms., Inc. v. Ajanta Pharma Ltd., 21-6964 (D.N.J.) Mar. 26, 2021 Hon. Freda L. Wolfson Trokendi XR® (topiramate extended-release capsules) 8,298,576
8,298,580
8,663,683
8,877,248
8,889,191
8,992,989
9,549,940
9,555,004
9,622,983
10,314,790
Akebia Therapeutics, Inc. v. Fibrogen, Inc., 21-0464 (D. Del.) Mar. 29, 2021 Hon. Colm F. Connolly Vafseo® (vadadustat tablets) 8,318,703
8,466,172
8,614,204
9,920,011
8,629,131
8,604,012
8,609,646
8,604,013
10,626,090
10,894,774
10,882,827
10,927,081

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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