Scilex Holding (SCLX) announced that the Company and its wholly owned subsidiary, Scilex Pharmaceuticals, have entered into a Settlement Agreement with Takeda Pharmaceuticals (TAK) and Takeda Pharmaceuticals Company to resolve the Paragraph IV patent infringement lawsuit that Takeda filed against the Scilex Parties in federal district court in Delaware in November 2023. That litigation arose from Scilex’s filing of a sNDA with the FDA seeking to expand the label for its FDA-approved liquid colchicine product, Gloperba, a preventive treatment for gout. As part of the Settlement Agreement, the Scilex Parties entered into a License Agreement with Takeda granting the Company and its affiliates a non-exclusive license to certain patents owned by Takeda. The terms of those agreements are confidential. The Settlement Agreement is subject to approval by the district court, and by both the Federal Trade Commission and the U.S. Department of Justice, as is required in Paragraph IV patent case settlements.
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