Company: TBPH
Filing Date: 2025-06-06
Form Type: 8-K
Source: 0001104659-25-056996
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Company: Theravance Biopharma, Inc.
Filing Date: 2025-06-06
Form: 8-K
Item: Item 8.01
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Item 8.01 Other Events

On
June 5, 2025, 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 LLC
(together, “ Mylan”), entered into a Settlement Agreement (the “ Settlement Agreement”) with Eugia Pharma Specialities
Ltd.; Eugia US LLC; Aurobindo Pharma Limited; and Aurobindo Pharma USA, Inc. (together, “ Eugia”) relating to Theravance and
Mylan’s YUPELRI ®and 12,285,417 (the “ Patents-in-Suit”).

The Settlement Agreement resolves ongoing patent litigation brought
by Theravance and Mylan against Eugia pursuant to the Hatch-Waxman Act based on Eugia’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 Eugia
a royalty-free, non-exclusive, non-sublicensable, non-transferable license to manufacture and market Eugia’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 as is customary in these type of agreements.

As required by law, the settlement is subject to review by the U. S.
Department of Justice and the Federal Trade Commission.

The patent litigation previously disclosed by the Company remains pending
against two other ANDA filers: Cipla Limited and Mankind Pharma Ltd.; along with certain affiliates.

SIGNATURE

Pursuant to the requirements of the Securities
Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

                          THERAVANCE BIOPHARMA, INC.                         
  Date: June 6, 2025      By:                             /s/ Brett Grimaud  
                                                          Brett Grimaud      
                                                          General Counsel