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Astellas US LLC v. Hospira, Inc.

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

Sanofi-Aventis U.S. LLC v. Apotex Corp. Jevtana® (Cabazitaxel)

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

Tris Pharma, Inc. V. Teva Pharms. Usa, Inc., Quillichew Er® (Methylphenidate)

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

Vifor Fresenius Medical Care Renal Pharma Ltd. v. Teva Pharms. USA, Inc.

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

United Therapeutics Corp. v. Liquidia Technologies, Inc. - Tyvaso® (Treprostinil)

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

AstraZeneca AB v. Zydus Pharms. (USA) Inc.

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

Melinta Therapeutics, LLC v. Nexus Pharms., Inc.

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

Pharmacyclics LLC v. Alvogen Pine Brook LLC

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

Par Pharmaceutical Inc. v. Eagle Pharmaceuticals Inc.

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

ANDA Litigation Settlements - Summer 2021

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

UCB, Inc. v. Actavis Labs. UT, Inc.

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

Mitsubishi Tanabe Pharma Co. v. Sandoz, Inc.

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

Vifor (Int’l) AG v. Mylan Labs. Ltd.

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

New ANDA Cases - Spring 2021

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

ANDA Litigation Settlements - Spring 2021

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

Horizon Medicines LLC v. Alkem Labs. Ltd.

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

Tris Pharma, Inc. v. Actavis Labs. FL, Inc.

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

Encore Dermatology Inc. v. Glenmark Pharms. Ltd.

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

GlaxoSmithKline LLC v. Teva Pharms. USA, Inc.

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

Valeant Pharm. N. Am. LLC v. Mylan Pharm. Inc.

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

New ANDA Cases - Winter 2021

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

Generic Launches - Winter 2021

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

ANDA Litigation Settlements - Winter 2021

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

ANDA Approvals - Winter 2021

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

Par Pharm., Inc. v. Hospira, Inc.

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

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