Company: TBPH
Filing Date: 2025-08-20
Form Type: 8-K
Source: 0001104659-25-080470
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Company: Theravance Biopharma, Inc.
Filing Date: 2025-08-20
Form: 8-K
Item: Item 8.01
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Item 8.01 Other Events

On August 15, 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 L. P. (together, “ Mylan”), entered into
a Settlement Agreement (the “ Settlement Agreement”) with Cipla Limited and Cipla USA, Inc. (“ Cipla”) 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. 8,541,451; 9,765,028; 10,550,081; 11,008,289; 11,484,531; 11,691,948; 8,017,783; 9,249,099;
10,100,013; 11,649,209; 11,858,898, 12,048,692 and 12,285,417 (the “ Patents-in-Suit”).

The Settlement Agreement resolves ongoing patent
litigation brought by Theravance and Mylan against Cipla pursuant to the Hatch-Waxman Act based on Cipla’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 Cipla a royalty-free, non-exclusive, non-sublicensable, non-transferable license to manufacture and market Cipla’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 one other ANDA filer: Mankind Pharma Ltd., along with certain affiliates.

SIGNATURE

Pursuant to the requirements of the Securities