Lupin settles patent infringement dispute with Astellas, to continue selling overactive bladder drug Mirabegron

Generic drugmaker Lupin has settled with Astellas Pharma a patent infringement dispute relating to overactive bladder drug Mirabegron.

The company and its wholly owned U.S. subsidiary Lupin Pharmaceuticals Inc. have entered into a settlement and license agreement with Astellas resolving the pending litigation and allowing Lupin to continue to sell Mirabegron.

Under the terms of the agreement, Lupin will pay Astellas $90 million, which includes a prepaid option payment of $75 million, and a prepaid per unit license fee for each unit of Lupin product sold from the date of the settlement through September 2027. The settlement terms are confidential, Lupin said in a filing on Tuesday (February 10, 2026).

Lupin had in April 2024 launched Mirabegron Extended-Release Tablets, 25 mg, a generic equivalent of Astellas Pharma Global Development Inc.’s Myrbetriq Extended-Release Tablets, 25 mg, in the U.S. following approval from the U.S. Food and Drug Administration (U.S. FDA). Citing then current industry sales numbers, it had had then said Mirabegron Extended-Release Tablets, 25 mg had estimated annual sales of $1,019 million in the U.S.

Astellas Pharma had filed a patent infringement case against Lupin. The United States District Court for the District of Delaware in April 2025 had ruled in favour of Astellas Pharma regarding the validity of its U.S. patent and said the issues of whether Lupin’s products infringe the patent, damages, and any additional invalidity theories will be litigated at a consolidated jury trial in 2026.