Zydus to launch mirabegron extended-release tablets in the USA

22 April 2024
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Indian generics major Zydus Lifesciences (NYSE: ZYDUSLIFE) today announced the launch of mirabegron extended-release tablets, 25mg in the US market.

The company had earlier received final approval from the US Food and Drug Administration (FDA) to market extended release mirabegron tablets USP 25mg and 50mg, a generic version of Myrbetriq extended-release tablets). Zydus is among the first suppliers to launch the generic version of mirabegron the US market and is prepared to launch the product imminently.

Myrbetriq was developed and is marketed by Japan’s Astellas Pharma (TYO: 4503), which last year lost a patent dispute, when the US District Court for the District of Delaware issued a decision finding that the company’s Patent No 10,842 on Myrbetriq (mirabegron), which expires in March 2030, is invalid.

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