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New ANDA Cases
Federal district court cases that are filed pursuant to the Hatch-Waxman Act
First Quarter
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 |
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