This chart tracks the date, drug, reference-listed company, and applicant of Abbreviated New Drug Applications and 505(b)(2) Applications receiving final approval by the FDA....more
2/1/2021
/ Abbreviated New Drug Application (ANDA) ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Life Sciences ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
Adrenalin® (epinephrine injection) -
Case Name: Par Pharm., Inc. v. Hospira, Inc., No. 2020-1273, 2020 WL 6846347 (Fed. Cir. Nov. 23, 2020) (Circuit Judges Dyk, Taranto, and Stoll presiding; Opinion by Taranto, J.)...more
1/29/2021
/ Abbreviated New Drug Application (ANDA) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Hospira ,
Intellectual Property Protection ,
Life Sciences ,
Par Pharmaceutical ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
Kinevac® (sincalide) -
Case Name: Bracco Diagnostics Inc. v. Maia Pharms., Inc., No. 2020-1387, 2020 WL 7393233 (Fed. Cir. Dec. 17, 2020) (Circuit Judges Lourie, Clevenger, and Chen presiding; Opinion by Lourie, J.)...more
1/28/2021
/ Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Life Sciences ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
Alimta® (pemetrexed disodium) -
Case Name: Eli Lilly & Co. v. Apotex, Inc., No. 2020-1328, 2020 WL 7490251 (Fed. Cir. Dec. 21, 2020) (Circuit Judges Prost, Bryson, and Stoll presiding; Opinion by Stoll, J.) (Appeal from...more
1/27/2021
/ Apotex ,
Eli Lilly ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Life Sciences ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
Colcrys®/colchicine -
Case Name: Takeda Pharms. U.S.A., Inc. v. Mylan Pharms. Inc., No. 2020-1407, -1417 (Fed. Cir. July 31, 2020) (Circuit Judges Prost, Newman, and Hughes presiding; Opinion by Prost, C.J.; Dissent by...more
11/4/2020
/ Abbreviated New Drug Application (ANDA) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Life Sciences ,
Mylan Pharmaceuticals ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Takeda Pharmaceuticals
Tirosint®/levothyroxine sodium -
Case Name: IBSA Institut Biochimique, S.A. v. Teva Pharms. USA, Inc., No. 2019-2400 (Fed. Cir. July 31, 2020) (Circuit Judges Prost, Reyna, and Hughes presiding; Opinion by Prost, C.J.)...more
11/3/2020
/ Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Life Sciences ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
POSITA ,
Prescription Drugs ,
Teva Pharmaceuticals
Eliquis®/apixaban -
Case Name: Bristol-Myers Squibb Co. v. Aurobindo Pharma USA Inc., No. 17-374-LPS (Consolidated), 2020 WL 4500226 (D. Del. Aug. 5, 2020) (Stark, J.)...more
11/2/2020
/ Abbreviated New Drug Application (ANDA) ,
Bristol-Myers Squibb ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Life Sciences ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
Riomet®/metformin HCl -
Case Name: Sun Pharm. Indus. Ltd. v. Saptalis Pharms., LLC, No. 18-648-WCB, 2020 WL 5077412 (D. Del. Aug. 6, 2020) (Bryson, J.)...
Drug Product and Patent(s)-in-Suit: Riomet® (metformin HCl);...more
10/30/2020
/ Abbreviated New Drug Application (ANDA) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Life Sciences ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
Case Name: Novartis Pharms. Corp. v. Accord Healthcare Inc., No. 18-1043-KAJ (D. Del. August 10, 2020) (Jordan, J.)...
Drug Product and Patent(s)-in-Suit: Gilenya® (fingolimod); U.S. Patent No. 9,187,405 (“the ’405...more
10/29/2020
/ Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Life Sciences ,
Novartis ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
Case Name: Noven Pharm., Inc. v. Amneal Pharms. LLC, No. 18-cv-00699 (D. Del. Sept. 2, 2020) (Stark, J.)...
Drug Product and Patent(s)-in-Suit: Minivelle® (estradiol); U.S. Patents Nos. 9,833,419 (“the ’419 patent”),...more
10/28/2020
/ Abbreviated New Drug Application (ANDA) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Life Sciences ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
Case Name: Biogen Int’l GmbH v. Amneal Pharmaceuticals LLC, Civ. No. 17-823 (MN), 2020 WL 5549084 (D. Del. Sept. 16, 2020) (Noreika, J.)...
Drug Product and Patent(s)-in-Suit: Tecfidera® (dimethyl fumarate (“DMF”)...more
10/27/2020
/ Abbreviated New Drug Application (ANDA) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Life Sciences ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
Reported settlements in federal district court cases -
This chart summarizes the case name, drug, patents-in-suit, and publicly available terms for reported settlements in federal district court cases that are filed...more
10/22/2020
/ Abbreviated New Drug Application (ANDA) ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Life Sciences ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Settlement Agreements