SECURITIES AND EXCHANGE COMMISSION
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Item 8.01 Other Events
On October 27, 2023, 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 Teva Pharmaceuticals, Inc. and Teva Pharmaceuticals USA, Inc. (together, “Teva”, and together with Theravance and Mylan, the “parties”) relating to Theravance and Mylan’s YUPELRI® (revefenacin) inhalation solution. A Theravance entity owns and Mylan is the exclusive sub-licensee of Orange Book-listed United States Patent Nos. 8,541,451; 9,765,028; 10,550,081; 11,008,289; 11,484,531; and 11,691,948 (the “Orange Book Listed Patents”).
The Settlement Agreement resolves ongoing patent litigation brought by Theravance and Mylan against Teva pursuant to the Hatch-Waxman Act based on Teva’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 Orange Book Listed Patents.
Under the Settlement Agreement, Theravance and Mylan granted Teva a royalty-free, non-exclusive, non-sublicensable, non-transferable license to manufacture and market Teva’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 against the other six ANDA filers, Accord Healthcare, Inc.; Cipla Limited; Eugia Pharma Specialities Ltd.; Lupin Inc.; Mankind Pharma Ltd.; and Orbicular Pharmaceutical Technologies Private Limited, along with certain affiliates, remains pending.
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: October 30, 2023||By:||
/s/ Brett Grimaud