Mirabegron Extended-Release Tablets is a generic version of US reference listed drug (USRLD) Myrbetriq Extended-Release Tablets of Astellas Pharma US, Inc.

"Zydus is among the first suppliers to launch the generic version of Mirabegron Extended-Release Tablets, USP 25 mg in the US market and is prepared to launch Mirabegron Extended-Release Tablets, 50mg imminently,” the Zydus said.

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.

Dr. Punit Patel, CEO Americas, 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 $2.42 billion in the US (IQVIA MAT February 2024).

The Zydus Group now has 393 approvals and has so far filed over 460 ANDAs since the commencement of the filing process in FY 2003-04.

Zydus Lifesciences is a discovery-driven, global lifesciences company that discovers, develops, manufactures, and markets a broad range of healthcare therapies.

The pharmaceutical company reported 26.76% increase in consolidated net profit of Rs 789.6 crore on 5.83% rise in revenue from operations to Rs 4,343.70 crore in Q3 FY24 over Q3 FY23.