Though Zydus Lifesciences opened slightly lower at Rs.386.05, it soon reversed the trend and surged up over 5% to an intraday high at Rs.406 on the back of robust volumes. Its 52-week high is at Rs.572.90.
The stock price rose after it announced receipt of USFDA's final nod to market its generic version of Mirabegron extended-release tablets.
Zydus was one of the first ANDA applicants to submit a substantially complete ANDA with a paragraph IV certification for Mirabegron Extended-Release Tablets, 25 mg and 50 mg and therefore is eligible for 180 days of shared generic drug exclusivity for Mirabegron Extended Release Tablets, 25 mg and 50 mg.
This is used to treat overactive bladder. The drug will be manufactured at the group’s formulation manufacturing facility at Ahmedabad SEZ, India.
Mirabegron Extended-Release Tablets USP 25mg and 50mg had annual sales of USD 2.42 bn in the United States according to IQVIA data (IQVIA MAT August 2022). The group now has 324 approvals and has so far filed over 428* ANDAs since the commencement of the filing process in FY 2003-04.