Zydus Settles Mirabegron Patent Dispute With Astellas for USD 120 Million
New Delhi: Zydus Lifesciences has entered into a settlement agreement with Astellas Pharma Inc. to resolve ongoing patent litigation in the United States related to Myrbetriq (Mirabegron).
The company informed the stock exchanges under Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015, that it, along with its wholly owned subsidiary Zydus Pharmaceuticals USA, Inc., has executed a Settlement Agreement with Astellas.
The development follows Zydus’ earlier disclosure dated April 17, 2025, regarding US patent litigation concerning Astellas’ Myrbetriq (generic name: Mirabegron).
Under the terms of the agreement, Zydus will pay Astellas an aggregate amount of USD 120 million. In addition, the company will pay a prepaid per-unit licensing fee on units of its generic Mirabegron sold in the US from the date of the Settlement Agreement through September 2027.
Other terms of the agreement remain confidential.
The settlement concludes all pending litigations between Astellas and Zydus relating to Myrbetriq and Mirabegron. Importantly, the agreement enables Zydus to continue marketing its generic Mirabegron in the United States.
Mirabegron is indicated for the treatment of overactive bladder and represents a significant product in the US urology segment. The resolution removes legal uncertainty around Zydus’ ability to continue selling the product in the highly competitive US generics market.
