Pharma Focus Asia

Scilex Holding Company Settles Patent Dispute with Takeda Pharmaceuticals Over Gloperba® Label Expansion

Thursday, March 21, 2024

Scilex Holding Company (Nasdaq: SCLX, "Scilex" or the "Company"), a company focused on acquiring, developing, and commercializing non-opioid pain management products for both acute and chronic pain, has announced a Settlement Agreement with Takeda Pharmaceuticals U.S.A., Inc. and Takeda Pharmaceuticals Company LTD. (collectively "Takeda"). This agreement aims to resolve a Paragraph IV patent infringement lawsuit filed by Takeda against the Scilex Parties in a federal district court in Delaware in November 2023. The lawsuit arose from Scilex's submission of a sNDA to the FDA to expand the label for its FDA-approved liquid colchicine product, Gloperba®, used as a preventive treatment for gout.

As part of the Settlement Agreement, the Scilex Parties have entered into a License Agreement with Takeda, granting the Company and its affiliates a non-exclusive license to certain patents owned by Takeda. The specific terms of these agreements remain confidential. The Settlement Agreement is subject to approval by the district court, as well as by both the Federal Trade Commission and the U.S. Department of Justice, as required in Paragraph IV patent case settlements.



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