Zydus Lifesciences Limited has reached a definitive settlement with Astellas Pharma Inc., resolving all ongoing US patent litigation related to Myrbetriq (Mirabegron). Under the terms of the agreement, Zydus will pay Astellas an aggregate sum of $120 million, in addition to ongoing prepaid per unit licensing fees for sales of its generic Mirabegron in the United States through September 2027.
The settlement, announced via a regulatory filing under Regulation 30 of the Securities and Exchange Board of India (Listing Obligations and Disclosure Requirements) Regulations, 2015, brings to a close a legal dispute that was previously disclosed by Zydus on April 17, 2025. The agreement encompasses both Zydus Lifesciences Limited and its wholly owned subsidiary, Zydus Pharmaceuticals USA, Inc.
According to the terms, Zydus is permitted to continue marketing its generic version of Mirabegron in the US market without further legal challenges from Astellas regarding this product. The financial arrangement includes a lump sum payment of $120 million and additional licensing fees calculated on a per-unit basis for each sale of generic Mirabegron in the US until September 2027.
While the principal financial terms have been disclosed, other details of the settlement remain confidential. The resolution allows both companies to avoid the costs and uncertainties associated with prolonged litigation, providing operational clarity for Zydus in the US generic pharmaceuticals sector.
The settlement announcement was formally signed by Dhaval N. Soni, Company Secretary and Compliance Officer for Zydus, and was filed with both BSE Limited and the National Stock Exchange of India Limited on February 12, 2026.
In a related regulatory matter, Zydus Lifesciences Limited’s board of directors reviewed penalties imposed by BSE and NSE for technical non-compliance with board meeting intimation requirements under SEBI regulations. Both exchanges levied penalties of ₹11,800 each (including GST) for insufficient prior notice of a board meeting held on November 6, 2025, which was convened to consider a fund-raising exercise.
The non-compliance stemmed from differing interpretations of working days between the company’s registered office in Ahmedabad and the exchanges in Mumbai. Zydus had considered November 5, 2025, as a working day based on the Reserve Bank of India’s holiday list for Ahmedabad, while the exchanges treated it as a holiday due to the Mumbai trading holiday for Prakash Gurpurb Sri Guru Nanak Dev.
At a board meeting on February 9, 2026, Zydus directors reviewed the penalty notices dated December 15, 2025, and the company’s responses dated December 29, 2025. The board determined that the technical non-compliance was inadvertent and resulted from the holiday calendar discrepancy, emphasizing that the company acted in good faith with no intent to violate regulatory requirements.
Zydus confirmed that both penalties were paid within the prescribed timeline and that replies were submitted to the exchanges acknowledging the payments. The board also committed to implementing strengthened compliance processes to prevent future technical non-compliances.
This dual resolution—of both the US patent litigation and the Indian regulatory penalties—marks a significant step for Zydus Lifesciences in reinforcing its compliance posture and securing its position in the US generic drug market.