Theravance (NASDAQ: TBPH) sets 2039 generic date in YUPELRI patent settlement

Filing Impact

(Moderate)

Filing Sentiment

(Neutral)

Form Type

8-K

Rhea-AI Filing Summary

Theravance Biopharma, Inc. announced a settlement of patent litigation over its YUPELRI® (revefenacin) inhalation solution. Theravance and its partner Mylan granted Mankind Pharma a royalty-free, non-exclusive license to sell a generic YUPELRI in the U.S. starting on the Licensed Launch Date of April 23, 2039, subject to customary exceptions.

The agreement resolves all pending Hatch-Waxman patent disputes related to YUPELRI. The settlement will be reviewed by the U.S. Department of Justice and the Federal Trade Commission, as required for patent settlements involving branded and generic drug makers.

Positive

YUPELRI® patent litigation resolved: All pending Hatch-Waxman cases over YUPELRI inhalation solution are settled, reducing legal uncertainty around a key respiratory product.
Generic entry timing defined: A royalty-free U.S. license allows Mankind’s generic YUPELRI to launch on or after April 23, 2039, giving investors clearer visibility on the drug’s long-term exclusivity period.

Negative

None.

Insights

Settlement locks in generic entry timing for YUPELRI, clarifying long-term IP protection.

Theravance and partner Mylan have settled Hatch-Waxman litigation with Mankind over YUPELRI® by granting a royalty-free, non-exclusive U.S. license for Mankind’s generic starting on April 23, 2039, with customary exceptions. This sets a clear earliest licensed launch date tied to the asserted patents.

The deal ends all pending patent litigation for YUPELRI® inhalation solution, removing legal uncertainty around this asset while preserving exclusivity for many years. Because the license is non-sublicensable and non-transferable, generic participation is contractually limited to the named party under the agreed terms.

The settlement remains subject to review by the U.S. Department of Justice and the Federal Trade Commission, a standard step for brand–generic patent agreements. Subsequent company filings may detail any additional commercial or competitive implications once regulatory review is completed.

8-K Event Classification

Item 8.01 — Other Events

1 item

Item 8.01 Other Events Other

Voluntary disclosure of events the company deems important to shareholders but not covered by other items.

Key Figures

Licensed Launch Date for generic YUPELRI: April 23, 2039 Patent No.: 11,484,531 Patent No.: 12,048,692 +1 more

4 metrics

Licensed Launch Date for generic YUPELRI April 23, 2039 Earliest licensed U.S. launch date for Mankind’s generic under settlement

Patent No. 11,484,531 One of three U.S. patents asserted for YUPELRI inhalation solution

Patent No. 12,048,692 One of three U.S. patents asserted for YUPELRI inhalation solution

Patent No. 12,285,417 One of three U.S. patents asserted for YUPELRI inhalation solution

Key Terms

Hatch-Waxman Act, abbreviated new drug application, royalty-free, non-exclusive, +2 more

6 terms

Hatch-Waxman Act regulatory

"The Settlement Agreement resolves patent litigation brought by Theravance and Mylan against Mankind pursuant to the Hatch-Waxman Act"

A U.S. law that created a faster approval route for generic drugs while allowing original drug makers limited extensions of their patent protection, balancing quicker competition with incentives to innovate. Think of it as a system that shortens the time for a copycat product to get regulatory clearance while preserving a temporary “fence” around the original maker’s market; this timing directly affects when sales and profits shift and is a key factor for investors valuing drug companies and forecasting revenue risks.

abbreviated new drug application regulatory

"based on Mankind’s filing of an abbreviated new drug application (“ANDA”) seeking approval to market a generic version"

An abbreviated new drug application is a regulatory submission used to gain approval to market a generic version of an already approved prescription medicine by showing it is equivalent in effect and safety to the original product, without repeating full clinical trials. For investors, an approval signals a lower-cost competitor entering the market that can quickly capture sales from the branded drug, similar to a generic knock‑off replacing a name‑brand item on store shelves.

royalty-free financial

"Theravance and Mylan granted Mankind a royalty-free, non-exclusive, non-sublicensable, non-transferable license"

non-exclusive financial

"granted Mankind a royalty-free, non-exclusive, non-sublicensable, non-transferable license"

Non-exclusive describes an arrangement where a party keeps the right to work with others or grant the same rights to multiple partners, rather than giving a sole or exclusive right. For investors, non-exclusive deals can speed distribution and reduce reliance on one counterparty, but may limit upside and strategic control because the same product, service or right can be sold or licensed to others.

Licensed Launch Date regulatory

"market Mankind’s generic version of YUPELRI inhalation solution in the United States on or after the Licensed Launch Date of April 23, 2039"

Emerging growth company regulatory

"405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934. Emerging growth company"

An emerging growth company is a recently public or smaller public firm that qualifies for temporary, lighter regulatory and disclosure rules to reduce the cost and effort of being public. For investors, it means the company may provide less historical financial detail and face fewer reporting requirements than larger firms, so it can grow more quickly but also carries higher uncertainty—like buying a promising early-stage product with fewer user reviews.

Understanding 8-K Material Events →

03/30/2026 - 05:34 PM

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): March 27, 2026

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

(Address, 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 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.

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: March 30, 2026	By:	/s/ Brett Grimaud
		Brett Grimaud
		General Counsel

Source: View Original Filing on SEC EDGAR

FAQ

What did Theravance Biopharma (TBPH) announce regarding YUPELRI?

Theravance Biopharma disclosed a settlement resolving patent litigation over YUPELRI® inhalation solution with Mankind Pharma. The agreement grants Mankind a defined future license for a generic version, ending all pending Hatch-Waxman disputes tied to YUPELRI while maintaining long-term patent-based protections.

When can Mankind launch its generic YUPELRI under the settlement with TBPH?

Mankind received a license to market its generic YUPELRI® inhalation solution in the United States on or after April 23, 2039. This Licensed Launch Date reflects the agreed resolution of Theravance and Mylan’s patent claims and clarifies the earliest licensed generic entry timing.

What kind of license did Theravance and Mylan grant to Mankind for generic YUPELRI?

Theravance and Mylan granted Mankind a royalty-free, non-exclusive, non-sublicensable, non-transferable license to manufacture and market a generic YUPELRI® in the United States. The license becomes effective on the Licensed Launch Date and includes customary exceptions and provisions typical for such settlements.

Does the YUPELRI patent settlement affect ongoing litigation for Theravance Biopharma (TBPH)?

Yes. With this Settlement Agreement, all pending Hatch-Waxman litigation relating to YUPELRI® inhalation solution has been resolved. This removes an active legal overhang tied to that product, although the underlying settlement remains subject to regulatory review by U.S. antitrust authorities.

Is the Theravance–Mankind YUPELRI settlement subject to regulatory review?

Yes. The settlement must be reviewed by the U.S. Department of Justice and the Federal Trade Commission, as required for certain brand–generic patent settlements. This review assesses competitive effects but does not itself alter the disclosed Licensed Launch Date terms.

Which patents were involved in the YUPELRI litigation settled by TBPH?

The litigation involved United States Patent Nos. 11,484,531, 12,048,692 and 12,285,417 covering YUPELRI® inhalation solution. A Theravance entity owns these patents, and Mylan is the exclusive sub-licensee. The settlement resolves disputes based on Mankind’s abbreviated new drug application.

Filing Exhibits & Attachments

3 documents

Theravance (NASDAQ: TBPH) sets 2039 generic date in YUPELRI patent settlement