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Informist, Thursday, Apr. 17, 2025

 

--Zydus Life: Will continue to market Mirabegron generic in US

--Zydus Life: No negotiations are on for settling Mirabegron case

--Zydus Life: Evaluating legal options on Mirabegron generic patent case

--CONTEXT: US court ruled against Zydus Life on Mirabegron patent litigation

 

By Narayana Krishna

 

HYDERABAD – Zyuds Lifesciences Ltd. Thursday made it clear that the company will continue to sell generic Mirabegron in the US market, despite patent-related legal hurdles. "The company is evaluating legal opinion on this matter. But, as of now it would be business as usual. The company continues to market the generic Mirabegron product in the US market," a Zydus Life spokesperson told Informist.

 

On possibilities of a settlement or negotiations to settle the patent dispute with the innovator, the spokesperson said nothing is clear as of now and that Zydus Life will continue to stick to legal opinions. "There are litigations on two patents. One patent is part of the (US court) judgment. There are other assertions that have not been addressed and that litigation is still on," the company said.

 

On Wednesday, Zydus Life said a US district court had passed an order against it in a litigation relating to the validity of a patent for Mirabegron generic held by Japanese company Astellas Pharma Inc. Another Indian pharmaceutical company Lupin Ltd. also lost the litigation on the same drug. The litigation was over a sustained release formulation of Mirabegron, sold in the US by Astellas Pharma under the brand name Myrbetriq. Mirabegron is a medication used to treat an overactive urinary bladder.

 

Following the US court outcome, JM Financial Institutional Equities said in its report that Zydus Life may have to pay INR 16 billion to INR 22 billion and Lupin may have to shell out INR 5 billion to INR 8 billion as damages to innovator Astellas Pharma.

 

According to multiple reports, the drug has over $2.5 billion in annual sales in the US, and Zydus Life is generating a revenue of around $35 million per quarter from this drug in the US. Zydus Life reported a consolidated net profit of INR 10.24 billion for the December quarter on a revenue of INR 52.69 billion.

 

At 1343 IST, shares of Zydus Life were at INR 828.25 on the National Stock Exchange, up 0.8% from the previous close.  End

 

US$1 = INR 85.58

IST, or Indian Standard Time, is five-and-a-half hours ahead of GMT

 

Edited by Nishant Maher

 

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