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TOKYO, February 12, 2026 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that it has reached separate agreements with Lupin Limited and Lupin Pharmaceuticals, Inc. (collectively “Lupin”), and Zydus Lifesciences Limited and Zydus Pharmaceuticals (USA) Inc. (collectively “Zydus”), to settle pending U.S. patent litigation regarding Astellas’ Myrbetriq® (generic name: Mirabegron).
1. Background and terms of the settlements
Under the terms of the separate settlement agreements with Lupin and Zydus, Astellas will receive a total of $60 million to resolve the litigations from the two companies combined. In addition, Astellas will receive upfront license payments totaling $150 million from the two companies combined, along with prepaid per-unit licensing fees for each unit sold by the companies in the United States. The remaining terms of the agreements are confidential.
This settlement concludes all litigation between Astellas and the two companies relating to Myrbetriq® and mirabegron.
2. Overview of the settlement counterparties
| I | Company name | Lupin Limited and Lupin Pharmaceuticals, Inc. |
| II | Location | -3rd Floor, Kalpataru Inspire, Off Western Express Highway, Santacruz (East), Mumbai 400 055, Maharashtra, India -111 South Calvert Street, 21st Floor Baltimore, Maryland 21202, United States |
| III | Title and name of the representative | Chief Executive Officer, Vinita Gupta |
| I | Company name | Zydus Lifesciences Limited and Zydus Pharmaceuticals (USA) Inc. |
| II | Location | -Zydus Corporate Park, Scheme No. 63, Survey No. 536, Khoraj (Gandhinagar), Near Vaishnodevi Circle, Sarkhej–Gandhinagar Highway, Ahmedabad – 382481, Gujarat, India -73 Route 31 North, Pennington, New Jersey 08534, United States |
| III | Title and name of the representative | Chairman, Pankaj R. Patel |
Astellas is reviewing potential financial impacts of this matter for the fiscal year ending March 31, 2026.
About Astellas
Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at www.astellas.com.
Cautionary Notes
In this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management’s current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas’ intellectual property rights by third parties. Information about pharmaceutical products (including products currently in development) which is included in this press release is not intended to constitute an advertisement or medical advice.
Contacts for inquiries:
Astellas Pharma Inc.
Corporate Communications
+81-3-3244-3201
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