Zydus Lifesciences has announced a major settlement agreement with Astellas Pharma in relation to the US patent litigation surrounding Myrbetriq® (generic name: Mirabegron). The agreement also involves Zydus Pharmaceuticals USA, Inc., the company’s wholly owned US subsidiary.
The development comes as a continuation of the earlier disclosure dated April 17, 2025, regarding the ongoing patent dispute in the United States.
Key Highlights of the Settlement Agreement
Under the terms of the agreement, Zydus will pay Astellas an aggregate amount of USD 120 million. In addition to this one-time settlement amount, Zydus will also pay a prepaid per-unit licensing fee on units of its generic Mirabegron sold in the US from the date of the settlement agreement until September 2027.
While the financial structure of the deal has been disclosed, other terms and conditions of the settlement remain confidential between the parties.
Litigation Concludes, Marketing to Continue
The settlement effectively concludes all ongoing litigations between Astellas and Zydus related to Myrbetriq® and Mirabegron in the US market. Importantly, the agreement enables Zydus to continue marketing its generic Mirabegron in the United States, removing legal uncertainty around the product.
Myrbetriq® is a branded formulation of Mirabegron, a medication used to treat overactive bladder. The resolution of this dispute provides clarity for Zydus’ US generics business and ensures continuity of supply in a competitive therapeutic segment.
