Theravance (NASDAQ: TBPH) sets 2039 date for Cipla YUPELRI generic

Rhea-AI Filing Summary

Theravance Biopharma, Inc. announced that its subsidiaries and partners Mylan Ireland Limited and Viatris Specialty L.P. have entered into a Settlement Agreement with Cipla Limited and Cipla USA, Inc. covering YUPELRI® (revefenacin) inhalation solution patents. The agreement resolves ongoing Hatch-Waxman patent litigation related to Cipla’s abbreviated new drug application for a generic YUPELRI® product in the United States.

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® in the United States on or after the Licensed Launch Date of April 23, 2039, subject to customary exceptions. The settlement is subject to review by the U.S. Department of Justice and the Federal Trade Commission, and separate patent litigation remains pending against another ANDA filer, Mankind Pharma Ltd. and certain affiliates.

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC  20549

FORM 8-K

Current Report Pursuant

to Section 13 or 15(d) of the

Securities Exchange Act of 1934

Date of Report (Date of earliest event Reported): August 15, 2025

THERAVANCE BIOPHARMA, INC.

(Exact Name of Registrant as Specified in its Charter)

Cayman Islands		001-36033		98-1226628
(State or Other Jurisdiction of		(Commission File Number)		(I.R.S. Employer Identification
Incorporation)				Number)

c/o Theravance Biopharma US, LLC

901 Gateway Boulevard

South San Francisco, CA 94080

(650) 808-6000

(Addresses, including zip code, and telephone numbers, including area code, of principal executive offices)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

¨  Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

¨  Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

¨  Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

¨  Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Ordinary Share $0.00001 Par Value		TBPH		NASDAQ Global Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company    ¨

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨

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 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:  August 20, 2025	By:	/s/ Brett Grimaud
		Brett Grimaud
		General Counsel

FAQ

What did Theravance Biopharma (TBPH) disclose about the YUPELRI patent dispute with Cipla?

Theravance Biopharma subsidiaries and their partners Mylan Ireland Limited and Viatris Specialty L.P. entered into a Settlement Agreement with Cipla Limited and Cipla USA, Inc. The agreement resolves Hatch-Waxman patent litigation over Cipla’s abbreviated new drug application for a generic version of YUPELRI® (revefenacin) inhalation solution in the United States.

When can Cipla launch its generic version of YUPELRI under the Theravance agreement?

Under the Settlement Agreement, Theravance and Mylan granted Cipla a royalty-free, non-exclusive license to manufacture and market its generic YUPELRI® inhalation solution in the United States on or after the Licensed Launch Date of April 23, 2039, subject to certain customary exceptions.

What type of license did Theravance and Mylan grant Cipla for the YUPELRI generic?

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, effective on or after April 23, 2039, with certain customary exceptions.

Is the Theravance–Cipla YUPELRI settlement final, or is any review required?

The settlement is subject to review by the U.S. Department of Justice and the Federal Trade Commission, as required by law. This regulatory review is a standard step for this type of patent settlement agreement.

Does Theravance still have other YUPELRI patent litigation pending after the Cipla settlement?

Yes. Theravance disclosed that patent litigation remains pending against another abbreviated new drug application filer, Mankind Pharma Ltd. and certain affiliates. The settlement with Cipla does not resolve that separate case.

Which patents are covered by the YUPELRI Settlement Agreement between Theravance, Mylan, and Cipla?

The agreement relates to multiple United States patents owned by a Theravance entity for YUPELRI® inhalation solution, including 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, which are referred to collectively as the Patents-in-Suit.