Zydus to settle Mirabegron patent litigation with Astellas by paying $120 million

Zydus Lifesciences has agreed to pay Astellas Pharma $120 million to settle the U.S. patent litigation with the latter over generic bladder disorder drug Mirabegron.

The company and subsidiary Zydus Pharmaceuticals USA, Inc., have entered into a settlement agreement with Astellas in relation to Astellas’ Myrbetriq (generic name: Mirabegron), Zydus said.

Under the agreement, Zydus will pay Astellas an aggregate amount of $120 million. Additionally, it will pay a prepaid per unit licensing fee on units of Zydus’ generic Mirabegron sold in the U.S. from the date of settlement agreement till September 2027. Other terms and conditions of the agreement remain confidential, Zydus said.

The agreement concludes all litigation between Astellas and the two companies relating to Myrbetriq and Mirabegron and enables Zydus to continue marketing its generic Mirabegron in the U.S., it said.

In April 2025, the United States District Court for the District of Delaware on a case filed by Astellas against Zydus pertaining to the validity of a U.S. patent had passed an order in favour of the innovator. Infringement of the patent, damages and any additional invalidity theories will be litigated at a consolidated jury trial in 2026, Zydus had said in a filing then.

Earlier this week, another Indian generic drugmaker Lupin had announced the signing of a settlement and license agreement with Astellas to resolve their pending litigation. Under the agreement Lupin will be paying $90 million to Astellas and get to continue selling Mirabegron.