Lupin has announced the settlement of its long-running patent infringement dispute with Astellas Pharma, bringing clarity to the future of its Mirabegron product in the United States market.
In a regulatory filing made under Regulation 30 read with Schedule III of the SEBI Listing Regulations, Lupin informed exchanges that it, along with its wholly owned subsidiary Lupin Pharmaceuticals Inc., USA, has entered into a Settlement and License Agreement with Astellas. The settlement follows earlier disclosures made on April 16, 2025, regarding the ongoing litigation related to Mirabegron.
As per the terms of the agreement, Lupin will make a total payment of USD 90 million to Astellas. This amount includes a prepaid option payment of USD 75 million. In addition, Lupin will pay a prepaid per-unit license fee for each unit of Mirabegron sold from the date of settlement until September 2027. The company noted that the detailed commercial terms of the settlement remain confidential.
The agreement effectively resolves all pending litigation between the two parties and allows Lupin to continue the sale of its Mirabegron product without legal uncertainty. Mirabegron is used in the treatment of overactive bladder and represents an important product in Lupin’s US generics portfolio.