Theravance Biopharma Resolves Patent Dispute over YUPELRI(R) Inhalation Solution with Eugia

Theravance Biopharma, Inc. has filed a current report with the US Securities and Exchange Commission, announcing the settlement of ongoing patent litigation with Eugia Pharma Specialities Ltd. over the YUPELRI(R) (revefenacin) inhalation solution. Under the terms of the agreement, Theravance granted Eugia a non-exclusive license to manufacture and market a generic version of YUPELRI(R) in the US, starting from April 23, 2039. This settlement resolves the dispute between the parties, while patent litigation against other ANDA filers, including Cipla Limited and Mankind Pharma Ltd., remains ongoing.

Key Takeaways:

  • Theravance Biopharma has resolved patent litigation with Eugia Pharma Specialities Ltd. over YUPELRI(R) inhalation solution.
  • The settlement grants Eugia a non-exclusive license to manufacture and market a generic version of YUPELRI(R) in the US, starting from April 23, 2039.
  • The license is royalty-free and non-sublicensable, and Eugia will not be allowed to transfer it to any other party.
  • The settlement is subject to review by the US Department of Justice and the Federal Trade Commission.
  • Patent litigation against other ANDA filers, including Cipla Limited and Mankind Pharma Ltd., remains ongoing.

Statistics:

  • Theravance Biopharma has resolved patent litigation with Eugia Pharma Specialities Ltd.
  • The settlement covers the YUPELRI(R) (revefenacin) inhalation solution.
  • The license will be effective from April 23, 2039.
  • The patent litigation remains pending against two other ANDA filers: Cipla Limited and Mankind Pharma Ltd.

Sources:

  • United States Securities and Exchange Commission (United States SEC) (Form 8-K, June 6, 2025)
  • Theravance Biopharma, Inc. (current report, June 6, 2025)
  • THERAVANCE BIOPHARMA, INC. (Form 8-K, June 6, 2025)