On March 27, 2026, Theravance Biopharma, Inc. announced that its subsidiaries, Theravance Biopharma R&D IP, LLC, Theravance Biopharma US, LLC, and Theravance Biopharma Ireland Limited, have entered into a Settlement Agreement with Mankind Pharma Ltd. and Lifestar Pharma LLC concerning the patent litigation related to YUPELRI (revefenacin) inhalation solution. This settlement resolves the ongoing patent litigation initiated by Theravance and Mylan against Mankind under the Hatch-Waxman Act, which was triggered by Mankind's filing of an abbreviated new drug application (ANDA) to market a generic version of YUPELRI before the expiration of the relevant patents. Under the terms of the Settlement Agreement, Mankind has been granted a royalty-free, non-exclusive, non-sublicensable, and non-transferable license to manufacture and market its generic version of YUPELRI in the United States starting from April 23, 2039, subject to customary provisions. The settlement is subject to review by the U.S. Department of Justice and the Federal Trade Commission, and it effectively resolves all pending Hatch-Waxman litigation concerning YUPELRI. This agreement is expected to have a small positive impact on Theravance's stock price as it clarifies the competitive landscape for YUPELRI and mitigates ongoing legal uncertainties.
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