Lupin Settles Mirabegron Patent Dispute With Astellas for USD 90 Million, Clears US Sales
Under the agreement, Lupin and its U.S. unit will pay Astellas a USD 75 million upfront payment and per-unit licensing fees on Mirabegron sales through September 2027, the company said in an exchange filing.
Mumbai: Indian drugmaker Lupin, opens new tab said on Tuesday it agreed to a USD 90 million settlement with Japan's Astellas Pharma (4503.T), opens new tab in a patent dispute over the bladder disorder drug Mirabegron, a move that allows it to continue selling the product in the United States.
Under the agreement, Lupin and its U.S. unit will pay Astellas a $75 million upfront payment and per-unit licensing fees on Mirabegron sales through September 2027, the company said in an exchange filing.
In a separate statement, the Japanese drugmaker said the settlement concludes its litigation with Lupin and added that it is reviewing the potential financial impact for the fiscal year ending March 31, 2026.
Lupin had previously disclosed the patent dispute with Astellas last April over its generic version of Myrbetriq, Astellas' overactive bladder drug, after a U.S. court ruling raised the risk that generic versions could be withdrawn from the market.
Citi analysts said the settlement removes legal uncertainty around Lupin's Mirabegron sales in the U.S. and could delay the entry of other generic rivals, potentially providing Lupin and Zydus Lifesciences (ZYDU.NS), opens new tab, another drugmaker involved in the litigation, with a period of limited competition.
