Zydus Lifesciences launches Mirabegron ER Tablets in US for overactive bladder treatment

Mirabegron is indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency and urinary frequency. The drug will be manufactured at the group’s formulation manufacturing facility in Ahmedabad SEZ, India.

Speaking on the launch, CEO Americas, Dr. Punit Patel, said, "As one of the first suppliers, we are pleased with the launch of generic Mirabegron which will improve access and availability of the generic product for patients in the US market. This is a significant launch for us which will strengthen our growth plans in US market in the current fiscal.”

Mirabegron Extended-Release Tablets USP 25mg and 50mg had annual sales of USD 2.42bn in the US (IQVIA MAT February 2024). The group now has 393 approvals and has so far filed over 460* ANDAs since the commencement of the filing process in FY 2003-04.

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Headquartered in Ahmedabad, Zydus Lifesciences Limited is an innovative, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies. The group has a significant presence in cancer-related therapies and offers a wide range of solutions with cytotoxic, supportive & targeted drugs. The group employs over 26,000 people worldwide, including 1,400 scientists engaged in R&D.