Theravance Biopharma Inc. filed SEC Form 8-K: Other Events
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Item 8.01 Other Events
On September 18, 2024, Theravance Biopharma R&D IP, LLC, Theravance Biopharma US, Inc. and Theravance Biopharma Ireland Limited, subsidiaries of the Registrant Theravance Biopharma, Inc. (together, “Theravance”), and Mylan Ireland Limited and Mylan Specialty L.P. (together, “Mylan”), entered into a Settlement Agreement (the “Settlement Agreement”) with Qilu Pharmaceutical Co., Ltd. and Qilu Pharma Inc. (together “Qilu”) 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; and 11,858,898 (the “Patents-in-Suit”).
The Settlement Agreement resolves ongoing patent litigation brought by Theravance and Mylan against Qilu pursuant to the Hatch-Waxman Act based on Qilu’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 Qilu a royalty-free, non-exclusive, non-sublicensable, non-transferable license to manufacture and market Qilu’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 three other ANDA filers: Cipla Limited; Eugia Pharma Specialities Ltd.; 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: September 23, 2024 | By: | /s/ Brett Grimaud |
| Brett Grimaud | ||
| General Counsel | ||