New ANDA Cases

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

First Quarter

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).
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

Oren D. Langer

Partner

Managing Partner, New York Office
Member of Executive Board

Back to Top