PFE - Theravance Biopharma Mylan settle patent dispute over Yupelri

2024-01-16 08:19:18 ET

Orbicular Pharmaceutical Technologies has agreed to resolve its patent fight with Theravance Biopharma ( NASDAQ: TBPH ) and Viatris ( NASDAQ: VTRS ) unit, Mylan, over the respiratory disorder therapy Yupelri.

Per the terms of the agreement, Orbicular will receive a royalty-free license to manufacture and market its Yupelri version on or after April 23, 2039. The U.S. Department of Justice and the Federal Trade Commission will next review the agreement.

The dispute relates to a lawsuit Theravance ( TBPH ) and Mylan filed against Orbicular over the latter’s request to obtain FDA approval for a generic version of Yupelri (revefenacin) inhalation solution before the expiry of related patents.

The settlement comes as Theravance ( TBPH ) and Mylan, which joined Pfizer ( PFE ) spinoff Upjohn in 2020 to establish Viatris ( VTRS ), are fighting to stave off knockoff versions of Yupelri, indicated in the U.S. for chronic obstructive pulmonary disease.

In October, the companies entered into a similar settlement agreement with Teva ( TEVA ), granting the Israeli drugmaker the right to market its Yupelri version in 2039.

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