At a Glance
- Astellas settles Myrbetriq patent litigation with Lupin and Zydus
- Combined settlement payments of $60 million
- Additional $150 million in upfront license payments plus per-unit fees
- Financial impact under review for FY2026
Written By: Pharmacally Medical News Desk
Astellas Pharma Inc announced that it has entered into separate settlement agreements with Lupin Limited and its U.S. subsidiary Lupin Pharmaceuticals, Inc., as well as Zydus Lifesciences Limited and Zydus Pharmaceuticals (USA) Inc., resolving pending U.S. patent litigation related to Myrbetriq® (mirabegron).
Under the terms of the agreements, Astellas will receive a combined total of $60 million from Lupin and Zydus to settle the disputes. In addition, the company will receive upfront license payments totalling $150 million, along with prepaid per-unit licensing fees tied to product sales in the United States. Other financial and commercial terms of the settlements were not disclosed.
The settlements conclude all litigation between Astellas and the two generic manufacturers concerning Myrbetriq and mirabegron. Patent disputes involving Myrbetriq have been closely watched given the product’s importance within Astellas’ urology portfolio and the competitive landscape for generic entry in the U.S. market.
Astellas stated that it is currently reviewing the potential financial impact of these agreements on its consolidated results for the fiscal year ending March 31, 2026.
Myrbetriq is approved for the treatment of overactive bladder and remains a key commercial product for the company.
Reference
Astellas Reaches Settlement Agreements with Lupin and Zydus in Myrbetriq® Patent Litigation, 12 February 2026, Astellas Reaches Settlement Agreements with Lupin and Zydus in Myrbetriq<sup>®</sup> Patent Litigation