Case Name: Sanofi-Aventis U.S. LLC v. Apotex Corp., C.A. No. 20-cv-804-RGA, 2022 WL 2643532 (D. Del. July 8, 2022) (Hall, J.) Drug Product and Patent(s)-in-Suit: Jevtana® (cabazitaxel); U.S. Patents Nos. 8,927,592 (“the ’592...more
12/9/2022
/ Abbreviated New Drug Application (ANDA) ,
Apotex ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Healthcare ,
Intellectual Property Protection ,
Life Sciences ,
Patent Infringement ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Sanofi-Aventis
Case Name: Tris Pharma, Inc. v. Teva Pharms. USA, Inc., Civ. No. 20-5212 (KM)(ESK) (D.N.J. Aug. 16, 2022) (McNulty, J.) Drug Product and Patent(s)-in-Suit: QuilliChew ER® (methylphenidate); U.S. Patents Nos. 9,545,399 (“the...more
11/29/2022
/ Abbreviated New Drug Application (ANDA) ,
Claim Limitations ,
Hatch-Waxman ,
Indefiniteness ,
Intellectual Property Protection ,
Obviousness ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Patents ,
Prescription Drugs
Case Name: H. Lundbeck A/S v. Lupin Ltd., Civ. No. 18-88-LPS (D. Del. Oct. 5, 2021) (Stark, J.) - Drug Product and Patent(s)-in-Suit: Trintellix® (vortioxetine hydrobromide); U.S. Patents Nos. 7,144,884 (“the ’884 patent”),...more
Case Name: Biogen Int’l GMBH v. Mylan Pharms. Inc., 18 F.4th 1333 (Fed. Cir. 2021) (Circuit Judges O’Malley, Reyna, and Hughes presiding; Opinion by Reyna; Dissent by O’Malley) (Appeal from N.D.W.V., Keeley, J.)...more
Case Name: AstraZeneca AB v. Mylan Pharms., Inc., No. 2021-1729, 2021 WL 5816742 (Fed. Cir. Dec. 8, 2021) (Circuit Judges Taranto, Hughes, and Stoll presiding; Opinion by Stoll, J.; Opinion dissenting in part by Taranto, J.)...more
Case Name: Amarin Pharma, Inc. v. Hikma Pharms. USA Inc., No. CV 20-1630-RGA-JLH, 2021 WL 3396199 (D. Del. Aug. 3, 2021) (Hall, J.) - Drug Product and Patent(s)-in-Suit: Vascepa® (icosapent ethyl); U.S. Patents Nos. 9,700,537...more
11/15/2021
/ Abbreviated New Drug Application (ANDA) ,
Amarin ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Life Sciences ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
Case Name: Sun Pharma Global FZE v. Lupin Ltd., Civ No. 18-2213 (FLW), 2021 WL 4473411 (D.N.J. Sept. 30, 2021) (Wolfson, J.) - Drug Product and Patent(s)-in-Suit: Bromsite® (bromfenac ophthalmic solution); U.S. Patent No....more
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...more
This chart tracks the date, drug, reference-listed company, applicant, and indications of publicly available drug launches resulting from Abbreviated New Drug Applications and 505(b)(2) Applications....more
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 pursuant to the Hatch-Waxman Act....more
8/10/2021
/ 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
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
Case Name: UCB, Inc. v. Actavis Labs. UT, Inc., Civ. No. 19-474-KAJ, 2021 WL 1880993 (D. Del. Mar. 26, 2021) (Jordan, J.) - Drug Product and Patent(s)-in-Suit: Neupro® (rotigotine); U.S. Patent No. 10,130,589 (“the ’589...more
8/6/2021
/ 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: Mitsubishi Tanabe Pharma Co. v. Sandoz, Inc., No. 17-5319, 2021 WL 1845499 (D.N.J. Apr. 7, 2021) (Wolfson, C.J.) - Drug Product and Patent(s)-in-Suit: Invokana® and Invokamet® (canagliflozin), U.S. Patents Nos....more
Case Name: Vifor (Int’l) AG v. Mylan Labs. Ltd., No. 19-13955 (FLW), 2021 WL 1608908 (D.N.J. Apr. 26, 2021) (Wolfson, J.) - Drug Product and Patent(s)-in-Suit: Injectafer® (ferric carboxymaltose injection); U.S. Patent No....more
8/4/2021
/ Abbreviated New Drug Application (ANDA) ,
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: Silvergate Pharms. Inc. v. Bionpharma Inc., No. 18-1962-LPS, 19-1067-LPS, 2021 WL 1751148 (D. Del. Apr. 29, 2021) (Stark, J.) - Drug Product and Patent(s)-in-Suit: Epaned® (enalapril maleate); U.S. Patents Nos....more
Case Name: UCB, Inc. v. Catalent Pharma Solutions, Inc., No. 5:21-cv-00038-GFVT, 2021 WL 1910079 (E.D. Ky. May 12, 2021) (Van Tatenhove, J.) - Drug Product and Patent(s)-in-Suit: Vimpat® (lacosamide); U.S. Patent No....more
Vimovo® (naproxen and esomeprazole magnesium) - Case Name: Horizon Medicines LLC v. Dr. Reddy’s Labs., Inc., No. 15-3324 (SRC), 2021 WL 616067 (D.N.J. Feb. 17, 2021) (Chesler, J.) - Drug Product and Patent(s)-in-Suit: Vimovo®...more
Symbicort® (budesonide and formoterol fumarate dihydrate) - Case Name: AstraZeneca AB v. Mylan Pharms. Inc., No. 1:18CV193, 2021 WL 798856 (N.D.W.V. Mar. 2, 2021) (Keeley, J.) - Drug Product and Patent(s)-in-Suit: Symbicort®...more
Case Name: Takeda Pharm. Co. Ltd. v. Torrent Pharms. Ltd., No. 2020-1552, -1598, 2021 WL 560763 (Fed. Cir. Feb. 16, 2021) (Circuit Judges Dyk, Mayer, and Chen presiding; Opinion by Chen, J.) (Appeal from D.N.J., Chesler, J.) ...more
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...more
4/26/2021
/ Abbreviated New Drug Application (ANDA) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Life Sciences ,
Orange Book ,
Patent Infringement ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
This chart tracks the date, drug, reference-listed company, applicant, and indications of publicly available drug launches resulting from Abbreviated New Drug Applications and 505(b)(2) Applications....more
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 pursuant to the Hatch-Waxman Act....more
4/22/2021
/ 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
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
Duexis® (ibuprofen / famotidine) -
Case Name: Horizon Medicines LLC v. Alkem Labs. Ltd., No. 18-1014-RGA, 2020 WL 7022591 (D. Del. Nov. 30, 2020) (Andrews, J.) ...more
2/12/2021
/ Doctrine of Equivalents ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Life Sciences ,
Patent Infringement ,
Patent Litigation ,
Patent-Eligible Subject Matter ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
Quillivant XR® (methylphenidate (“MPH”)) -
Case Name: Tris Pharma, Inc. v. Actavis Labs. FL, Inc., No. 14-1309-CFC, 2020 WL 7028456 (D. Del. Nov. 30, 2020) (Connolly, J.)...more
2/11/2021
/ Abbreviated New Drug Application (ANDA) ,
Actavis Inc. ,
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