Item 8.01. Other Events On March 27, 2026, Theravance Biopharma R&D IP, LLC, Theravance Biopharma US, LLC and Theravance Biopharma Ireland Limited, subsidiaries of the Registrant Theravance Biopharma, Inc. (together, “Theravance”), and Mylan Ireland Limited and Viatris Specialty L.P. (together, “Mylan”), entered into a Settlement Agreement (the “Settlement Agreement”) with Mankind Pharma Ltd. and Lifestar Pharma LLC (“Mankind”) relating to Theravance and Mylan’s YUPELRI ® (revefenacin) inhalation solution. A Theravance entity owns and Mylan is the exclusive sub-licensee of United States Patent Nos. 11,484,531, 12,048,692 and 12,285,417 (the “Patents-in-Suit”). The Settlement Agreement resolves patent litigation brought by Theravance and Mylan against Mankind pursuant to the Hatch-Waxman Act based on Mankind’s filing of an abbreviated new drug application (“ANDA”) seeking approval to market a generic version of YUPELRI ® (revefenacin) inhalation solution prior to expiration of the Patents-in-Suit. Under the Settlement Agreement, Theravance and Mylan granted Mankind a royalty-free, non-exclusive, non-sublicensable, non-transferable license to manufacture and market Mankind’s generic version of YUPELRI ® (revefenacin) inhalation solution in the United States on or after the Licensed Launch Date of April 23, 2039, subject to certain exceptions and other provisions customary for agreements of this type. As required by law, the settlement is subject to review by the U.S. Department of Justice and the Federal Trade Commission. With this Settlement Agreement, all pending Hatch-Waxman litigation relating to YUPELRI ® (revefenacin) inhalation solution has been resolved.
TBPH Theravance Biopharma, Inc. - 8-K
Accession
0001104659-26-0368708.01
Item 8.01 - Other Events
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