Zydus Settles Mirabegron Patent Dispute with Astellas for $120 Million

Zydus Lifesciences has entered into a settlement agreement with Astellas Pharma Inc. to resolve ongoing patent litigation in the United States related to Myrbetriq (Mirabegron). Under the terms of the agreement, Zydus will pay Astellas an aggregate amount of $120 million, plus a prepaid per-unit licensing fee on units of its generic Mirabegron sold in the US from the date of the Settlement Agreement through September 2027.

The settlement concludes all pending litigations between Astellas and Zydus relating to Myrbetriq and Mirabegron. The agreement enables Zydus to continue marketing its generic Mirabegron in the United States.

Zydus, along with its wholly owned subsidiary Zydus Pharmaceuticals USA, Inc., executed the Settlement Agreement with Astellas. The company informed the stock exchanges under Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015. Other terms of the settlement were not disclosed citing confidentiality.

The Ahmedabad-based drugmaker obtained FDA approval to market the drug in 2024. However, Astellas Pharma sued the company citing infringement of its existing patent. In April 2025, the Delaware district court upheld the validity of Astellas Pharma's patent and rejected the plea filed by Zydus.

Mirabegron is a selective beta-3 adrenergic agonist indicated for the treatment of Overactive Bladder (OAB) in adults. The drug is marketed by Astellas Pharma under the brand name Myrbetriq.

Alongside Zydus, Mumbai-based Lupin was also sued by the company on similar grounds. Lupin settled its dispute earlier for $90 million, along with an additional per-unit licensing fee, highlighting a trend of patent dispute resolutions in the generics space.

The settlement was disclosed as part of Zydus Lifesciences' third quarter fiscal year 2026 results, during which the company reported consolidated revenues of ₹68.6 billion, marking a 30% year-on-year increase. The company's operational profitability saw EBITDA climbing 31% year-on-year to ₹18.2 billion, leading to an EBITDA margin of 26.5%, a 20 basis points improvement over the previous year. Consolidated net profit stood at ₹11.1 billion, marking a 9% increase year-on-year, adjusted for exceptional expenses related to acquisitions.

The company's US business reported an 11% volume growth in the calendar year, outperforming the market, and saw 18 Abbreviated New Drug Applications (ANDAs) filed, with 8 approvals and 4 new product launches in the quarter. The specialty segment launched BEIZRAY and received USFDA approval for Zycubo.

The net debt stands at ₹3,000 crore, a result of recent acquisitions, which management considers manageable. Management expressed confidence in sustained double-digit growth across businesses, projecting EBITDA margins to remain above 23% in Q4 FY26.