Scilex Holding Announce Final Court Approval Settlement Agreement With Takeda Pharmaceuticals To Resolve The Paragraph IV Patent Infringement Lawsuit

Author: Benzinga Newsdesk | May 14, 2024 09:03am

Scilex Holding Company (NASDAQ:SCLX, "Scilex" or "Company"))))), an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain, today announced that the 45-day review period for the U.S. Federal Trade Commission and U.S. Department of Justice to comment on or object to the Settlement Agreement (the "Settlement Agreement") entered into by the Company and its wholly owned subsidiary, Scilex Pharmaceuticals Inc. ("Scilex Pharma" and, together with the Company, the "Scilex Parties") with Takeda Pharmaceuticals U.S.A., Inc. and Takeda Pharmaceuticals Company LTD. (collectively "Takeda") to resolve the Paragraph IV patent infringement lawsuit (the "Action") that Takeda filed against the Scilex Parties in the federal district court in Delaware in November 2023 has expired and the U.S. District Court for the District of Delaware entered a Consent Judgment on May 3, 2024, approving the Settlement Agreement. The Action arose from Scilex's filing of a revised label 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.
 

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