8-K - Theravance Biopharma, Inc. | StockGist

AI Analysis

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Theravance Biopharma and Mylan settled patent litigation with Mankind Pharma, granting a royalty-free license for generic YUPELRI inhalation solution starting April 23, 2039, resolving all related Hatch-Waxman cases.

Key Takeaways

1Settlement Agreement entered March 27, 2026, between Theravance subsidiaries, Mylan, and Mankind Pharma.

2Resolves Hatch-Waxman litigation over Mankind's ANDA for generic YUPELRI prior to Patents-in-Suit expiration.

3Royalty-free, non-exclusive license for Mankind to launch generic YUPELRI in US on or after April 23, 2039.

4All pending Hatch-Waxman litigation for YUPELRI now resolved.

5Settlement subject to US DOJ and FTC review.

Current Report Details

Event Type

Other Event

Disclosure

Voluntary

Variant

8-K

Items Reported

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 th

Other Event

Transaction Details

Material Agreement

Agreement: Settlement Agreement
Parties: Theravance Biopharma R&D IP, LLC, Theravance Biopharma US, LLC, Theravance Biopharma Ireland Limited, Mylan Ireland Limited, Viatris Specialty L.P., Mankind Pharma Ltd., Lifestar Pharma LLC

•Resolves patent litigation under Hatch-Waxman Act related to YUPELRI (revefenacin) inhalation solution
•Grants royalty-free, non-exclusive, non-sublicensable, non-transferable license to manufacture and market generic version in US on or after April 23, 2039
•Subject to review by U.S. Department of Justice and Federal Trade Commission
•Resolves all pending Hatch-Waxman litigation relating to YUPELRI

Exhibits (1)

8-K

FORM 8-K