CoverageForm 410-K10-Q8-K13D13G13F

TBPH Theravance Biopharma, Inc. - 8-K

Filed Mar 30, 2026. See issuer overview · financials · original on SEC.gov ↗
Accession
0001104659-26-036870
8.01

Item 8.01 - Other Events

232 words

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.