At a Glance
- Astellas and Lupin have settled U.S. patent litigation related to Myrbetriq (mirabegron)
- The agreement resolves all disputes between the two companies; terms remain confidential
- Patent litigations involving other generic manufacturers are still ongoing
- Astellas is assessing the potential financial impact for FY ending March 31, 2026
Written By: Pharmacally Medical News Desk
Astellas Pharma Inc. announced that it has reached a settlement agreement with Lupin Limited and its U.S. subsidiary, Lupin Pharmaceuticals, Inc., resolving pending patent litigation in the United States related to Myrbetriq (mirabegron).
The settlement brings to a close all legal disputes between Astellas and Lupin concerning Myrbetriq and its generic equivalent, mirabegron. Financial and commercial terms of the agreement have not been disclosed, consistent with standard practice in patent settlement cases.
Astellas clarified that litigation involving Myrbetriq with other generic manufacturers remains ongoing, and the current settlement does not affect those separate proceedings.
The company also stated that it is evaluating the potential financial impact of the Lupin settlement on its consolidated results for the fiscal year ending March 31, 2026. No further details were provided at this time.
Myrbetriq is a key product in Astellas’ urology portfolio and is approved for the treatment of overactive bladder. Patent disputes around the product reflect broader competitive dynamics as generic manufacturers seek market entry in the U.S.
Astellas said it will continue to provide updates as appropriate in line with regulatory disclosure requirements.
Reference
Astellas Reaches Settlement Agreement with Lupin in Myrbetriq® Patent Litigation, 10 February 2026, Astellas Reaches Settlement Agreement with Lupin in Myrbetriq<sup>®</sup> Patent Litigation