Case Name: Astellas US LLC v. Hospira, Inc., No. 2022-1878, 2022 WL 17998229 (Fed. Cir. Dec. 30, 2022) (Circuit Judges Dyk, Reyna, and Cunningham presiding; Opinion by Dyk, J.) (Appeal from D. Del., Connolly, J.)...more
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: Vifor Fresenius Medical Care Renal Pharma Ltd. v. Teva Pharms. USA, Inc., Civ. No. 18-390 (MN), 2022 WL 3562555 (D. Del. Aug. 18, 2022) (Noreika, J.) Drug Product and Patent(s)-in-Suit: Velphoro® (sucroferric...more
Case Name: United Therapeutics Corp. v. Liquidia Technologies, Inc., Civ. No. 20-755-RGA, 2022 WL 3910252 (D. Del. Aug. 31, 2022) (Andrews, J.) Drug Product and Patent(s)-in-Suit: Tyvaso® (treprostinil); U.S. Patents Nos....more
Case Name: AstraZeneca AB v. Zydus Pharms. (USA) Inc., C.A. No. 18-664-RGA, 2021 WL 4819905 (D. Del. Oct. 15, 2021) (Andrews, J.) Drug Product and Patent(s)-in-Suit: Farxiga® (dapagliflozin); U.S. Patent No. 6,515,117 (“the...more
Case Name: Melinta Therapeutics, LLC v. Nexus Pharms., Inc., C.A. No. 2:21-cv-11198 (BRM) (AME), 2021 WL 5150157 (D.N.J Nov. 5, 2021) (Martinotti, J.) - Drug Product and Patent(s)-in-Suit: Minocin® (minocycline HCl); U.S....more
Case Name: Pharmacyclics LLC v. Alvogen Pine Brook LLC, No. 19-0434, 2021 WL 3680317 (D. Del. Aug. 19, 2021) (Connolly, J.) Drug Product and Patent(s)-in-Suit: Imbruvica® (ibrutinib); U.S. Patents Nos. 8,008,309 (“the ’309...more
Case Name: Par Pharmaceutical Inc. v. Eagle Pharmaceuticals Inc., No. 18-0823-CFC-JLH, 2021 WL 3886418 (D. Del. Aug. 31, 2021) (Connolly, J.) -
Drug Product and Patent(s)-in-Suit: Vasostrict® (vasopressin); U.S. Patents...more
11/11/2021
/ Abbreviated New Drug Application (ANDA) ,
Hatch-Waxman ,
Intellectual Property Protection ,
Life Sciences ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Preponderance of the Evidence
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
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
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 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
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
Impoyz® (clobetasol) -
Case Name: Encore Dermatology Inc. v. Glenmark Pharms. Ltd., Civ. No. 20-02509 (KM) (ESK), 2020 WL 7586958 (D.N.J. Dec. 22, 2020) (McNulty, J.)...more
2/10/2021
/ 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
Coreg® (carvedilol) -
Case Name: GlaxoSmithKline LLC v. Teva Pharms. USA, Inc., No. 2018-1976, -2023 (Fed. Cir. Oct. 2, 2020) (Circuit Judges Prost, Newman, and Moore presiding; Opinion by Newman, J.; Dissent by Prost, C.J.)...more
2/9/2021
/ Abbreviated New Drug Application (ANDA) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
GlaxoSmithKline ,
Hatch-Waxman ,
Intellectual Property Protection ,
Life Sciences ,
Patent Infringement ,
Patent Litigation ,
Patent-in-Suit ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Popular ,
Prescription Drugs ,
Teva Pharmaceuticals
Jublia® (efinaconazole) -
Case Name: Valeant Pharm. N. Am. LLC v. Mylan Pharm. Inc.,978 F.3d 1374 (Fed. Cir. Nov. 5, 2020)(Circuit Judges Newman, O’Malley, and Taranto presiding; Opinion by O’Malley, J.) (Appeal from D.N.J.,...more
2/8/2021
/ 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 ,
Valeant
Federal District Court Cases That Are Filed Pursuant To The Hatch-Waxman Act -
This chart summarizes the case name, presiding judge, drug, and patents-at-issue in all federal district court cases that are filed pursuant to...more
2/4/2021
/ 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
2/3/2021
/ Abbreviated New Drug Application (ANDA) ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Intellectual Property Protection ,
Life Sciences ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs
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
2/2/2021
/ 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 ,
Settlement
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