KEY POINTS
- India’s Zydus Lifesciences and its U.S. arm will pay $120 million to settle Mirabegron patent litigation.
- The deal includes prepaid licensing fees to sustain U.S. generic sales through 2027.
- Settlement follows a similar $90M deal between Astellas and rival Lupin.
India’s Zydus Lifesciences and its U.S. subsidiary have struck a $120 million settlement to end a patent dispute with Japan’s Astellas Pharma over the bladder drug Mirabegron.
Zydus said the agreement resolves litigation around its generic version of the medication commonly used to treat overactive bladder.
Under the deal, Zydus and Zydus Pharmaceuticals USA will pay Astellas an upfront sum of $120 million. The settlement also includes prepaid per-unit licensing fees tied to the sale of generic Mirabegron in the United States.
These licensing payments will apply from the date of the settlement through September 2027. Zydus said other terms of the agreement remain confidential and did not disclose detailed licensing fee amounts.
The settlement allows Zydus to continue marketing its generic drug in the U.S. market without further legal challenge. It comes shortly after rival Indian drugmaker Lupin reached a $90 million patent settlement with Astellas over the same product.
Analysts have said such settlements may delay the entry of additional generic competitors in the U.S. market. The disputes stem from Astellas’ intellectual property rights on its branded version of Mirabegron, marketed under the name Myrbetriq.
Legal challenges by generic producers threatened to curtail sales due to alleged patent infringement. By settling, Zydus secures continued U.S. sales while providing certainty to its supply chain and customers.
Zydus shares climbed after the announcement of the settlement, reflecting investor confidence in ongoing market access.
Astellas Pharma has not publicly disclosed its view on the settlement’s financial impact.
The parties notified regulators and exchanges about the deal, complying with disclosure requirements in India and the U.S. The agreement ends lengthy litigation that began after Zydus challenged the Astellas patent in U.S. courts.
Under the contract, the per-unit licensing fee is prepaid, providing Astellas with immediate revenue. Zydus has not yet revealed how its pricing strategy for generic Mirabegron might change post-settlement.
Market watchers expect the deal could shape how other generics approach patent disputes against branded drugs.
Industry observers say such agreements reflect a broader trend of settlements resolving complex patent litigation. The settlement highlights the commercial importance of Mirabegron in the U.S. pharmaceutical market.
Zydus is now positioned to focus on manufacturing, distribution and marketing rather than extended legal battles. Astellas can reallocate resources to other research and product efforts following resolution of these disputes.
