News & Analysis as of

Abbreviated New Drug Application (ANDA) Food and Drug Administration (FDA) Patent-in-Suit

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Pharmacyclics LLC v. Alvogen Pine Brook LLC - Imbruvica® (Ibrutinib)

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Case Name: Pharmacyclics LLC v. Alvogen Pine Brook LLC, Civ. No. 19-434-CFC, 2024 WL 1885677 (D. Del. Apr. 30, 2024) (Connolly, J.) - Drug Product and Patent(s)-in-Suit: Imbruvica® (ibrutinib); U.S. Patents Nos. 8,008,309...more

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Teva Branded Pharm. Products R&D, Inc. v. Amneal Pharms. of NY, LLC - ProAir® HFA (Albuterol Sulfate)

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Case Name: Teva Branded Pharm. Products R&D, Inc. v. Amneal Pharms. of NY, LLC, Civ. No. 23-20964 (SRC), 2024 WL 2923018 (D.N.J. June 10, 2024) (Chesler, J.)....more

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Janssen Pharms., Inc. v. Tolmar, Inc. - Invega Sustenna® (Paliperidone Palmitate)

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Case Name: Janssen Pharms., Inc. v. Tolmar, Inc., Civ. No. 21-1784-WCB, 2024 WL 2972832 (D. Del. June 13, 2024) (Bryson, J.) - Drug Product and Patent(s)-in-Suit: Invega Sustenna® (paliperidone palmitate); U.S. Patent No....more

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Janssen Pharms., Inc. v. Teva Pharms. USA, Inc. - Invega Sustenna® (Paliperidone Palmitate)

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Case Name: Janssen Pharms., Inc. v. Teva Pharms. USA, Inc., No. 2022-1258, 2022-1307, 2024 WL 1355733 (Fed. Cir. Apr. 1, 2024) (Circuit Judges Dyk, Prost, and Hughes presiding; Opinion by Prost, J.) (Appeal from D.N.J.,...more

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Salix Pharms., Ltd. v. Norwich Pharms. Inc. - Xifaxan® (Rifaximin)

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Case Name: Salix Pharms., Ltd. v. Norwich Pharms. Inc., No. 2022-2153, 2023-1952, 2024 WL 1561195 (Fed. Cir. Apr. 11, 2024) (Circuit Judges Lourie, Chen, and Cunningham presiding; Opinion by Lourie, J.; Dissenting-in-part...more

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Amarin Pharma, Inc. v. Hikma Pharms. USA Inc. - Vascepa® (Icosapent Ethyl)

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Case Name: Amarin Pharma, Inc. v. Hikma Pharms. USA Inc., No. 2023-1169, 2024 WL 3152087 (Fed. Cir. June 25, 2024) (Circuit Judges Moore, Lourie, and Albright presiding; Opinion by Lourie, J.) (Appeal from D. Del., Andrews,...more

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Mylan Pharms. Inc. v. Bayer Intellectual Property GmbH, C.A. - Xarelto® (Rivaroxaban)

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Case Name: Mylan Pharms. Inc. v. Bayer Intellectual Property GmbH, C.A. No. 23-556-RGA, 2024 WL 359468 (D. Del. Jan. 31, 2024) (Hatcher, M.J.) - Drug Product and Patent(s)-in-Suit: Xarelto® (rivaroxaban); U.S. Patents Nos....more

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Novartis Pharms. Corp. v. Mylan Pharms. Inc. - Entresto® (Sacubitril/Valsartan)

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Case Name: Novartis Pharms. Corp. v. Mylan Pharms. Inc., Civ. No. 19-cv-201, 2024 WL 384929 (N.D.W.V. Jan. 31, 2024) (Kleeh, J.) - Drug Product and Patent(s)-in-Suit: Entresto® (sacubitril/valsartan); U.S. Patents Nos....more

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Endo Par Innovation Co. v. BPI Labs, LLC - Adrenalin® (Epinephrine)

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Case Name: Endo Par Innovation Co. v. BPI Labs, LLC, C.A. No. 8:23-cv-1953-WFJ-TGW, 2024 WL 730478 (M.D. Fla. Feb. 22, 2024) (Jung, J.) - Drug Product and Patent(s)-in-Suit: Adrenalin® (epinephrine); U.S. Patents Nos....more

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Genentech, Inc. v. Sandoz, Inc. - Esbriet® (Pirfenidone)

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Case Name: Genentech, Inc. v. Sandoz, Inc., Civ No. 23-4085 (JXN)(LDW), 2024 WL 939692 (D.N.J. Mar. 5, 2024) (Wettre, M.J.) - Drug Product and Patent(s)-in-Suit: Esbriet® (pirfenidone); U.S. Patent No. 10,118,637 (“the ’637...more

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Bausch Health Ireland Ltd. v. Padagis Israel Pharms. Ltd. - Arazlo® (Tazarotene)

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Case Name: Bausch Health Ireland Ltd. v. Padagis Israel Pharms. Ltd., Civ. No. 22-4248 (SRC), 2023 WL 7131809 (D.N.J. Oct. 30, 2023) (Chesler, J.) - Drug Product and Patent(s)-in-Suit: Arazlo® (tazarotene); U.S. Patent Nos....more

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Norwich Pharms., Inc. v. Becerra - Xifaxan® (Rifaximin)

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Case Name: Norwich Pharms., Inc. v. Becerra, Civ. No. 23-1611 (RDM), 2023 WL 7174558 (D.D.C. Nov. 1, 2023) (Moss, J.) - Drug Product and Patent(s)-in-Suit: Xifaxan® (rifaximin); U.S. Patents Nos. 7,612,199 (“the ’199...more

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Eisai R&D Mgmt. Co., Ltd. v. Dr Reddy’s Labs., Inc. - Halaven® (Eribulin Mesylate)

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Case Name: Eisai R&D Mgmt. Co., Ltd. v. Dr Reddy’s Labs., Inc., No. 22-CV-5950, 2023 WL 7331272 (D.N.J. Nov. 7, 2023) (Chesler, J.) - Drug Product and Patent(s)-in-Suit: Halaven® (eribulin mesylate); U.S. Patents Nos....more

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Corcept Therapeutics, Inc. v. Teva Pharms. USA, Inc. - Korlym® (Mifepristone)

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Case Name: Corcept Therapeutics, Inc. v. Teva Pharms. USA, Inc., No. 18-CV-03632 (RMB/LDW), 2023 WL 9017081 (D.N.J. Dec. 29, 2023) (Bumb, J.) - Drug Product and Patent(s)-in-Suit: Korlym® (mifepristone); U.S. Patents Nos....more

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Actelion Pharms. Ltd. v. Mylan Pharms. Inc. - Veletri® (Epoprostenol)

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Case Name: Actelion Pharms. Ltd. v. Mylan Pharms. Inc., No. 2022-1889, 2023 WL 7289417 (Fed. Cir. Nov. 6, 2023) (Circuit Judges Reyna, Stoll, and Stark presiding; Opinion by Stoll, J.) (Appeal from N.D.W.V., Bailey, J.) - ...more

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H. Lundbeck A/S v. Lupin Ltd. - Trintellix® (Vortioxetine)

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Case Name: H. Lundbeck A/S v. Lupin Ltd., 87 F.4th 1361, 2023 WL 8462010 (Fed. Cir. Dec. 7, 2023) (Circuit Judges Dyk, Prost, and Hughes presiding; Opinion by Dyk, J.) - Drug Product and Patent(s)-in-Suit: Trintellix®...more

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Novartis Pharms. Corp. v. Mylan Pharms. Inc. - Entresto® (Sacubitril / Valsartan)

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Case Name: Novartis Pharms. Corp. v. Mylan Pharms. Inc., Civ. No. 19-cv-201, 2023 WL 4375445 (N.D.W.V. July 6, 2023) (Kleeh, J.) - Drug Product and Patent(s)-in-Suit: Entresto® (sacubitril / valsartan); U.S. Patents Nos....more

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Bristol-Myers Squibb Co. v. Xspray Pharma AB Sprycel®/Dasynoc® (Dasatinib)

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Case Name: Bristol-Myers Squibb Co. v. Xspray Pharma AB , No. CV 22-964 (RMB/MJS), 2023 WL 3354261 (D.N.J. Apr. 25, 2023) (Bumb, J.) Drug Product and Patent(s)-in-Suit: Sprycel®/Dasynoc® (dasatinib) U.S. Patents Nos....more

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Azurity Pharms., Inc. v. Alkem Labs. Ltd. - Epaned® (Enalapril Maleate)

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Case Name: Azurity Pharms., Inc. v. Alkem Labs. Ltd., No. 19-cv-2100, 2023 WL 1927613 (D. Del. Feb. 10, 2023) (Goldberg, J.) - Drug Product and Patents-in-Suit: Epaned® (enalapril maleate); U.S. Patents Nos. 10,786,482...more

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

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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

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

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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

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Amarin Pharma, Inc. v. Hikma Pharms. USA Inc.

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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

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Chief Judge Connolly Issues Comprehensive Opinion Setting Forth Court’s Findings Of Fact And Conclusions Of Law On Infringement...

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By Memorandum Opinion entered by The Honorable Colm F. Connolly in Pharmacyclics LLC et al. v. Alvogen Pine Brook LLC et al., Civil Action No. 19-0434-CFC-CJB (D.Del. August 19, 2021), the Court set forth its findings of fact...more

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ANDA Litigation Settlements - Summer 2021

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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

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

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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

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