- 04 Oct 2022
- ICICIdirect Research
SHARED EXCLUSIVITY FOR MIRABEGRON ER TABLETS IN US
ZYDUSLIFE - 995 Change: 6.50 (0.66 %)News:
Zydus Lifesciences has received final approval from USFDA to market Mirabegron Extended-Release Tablets in strengths of 25mg and 50mg (USRLD:Myrbetriq) and is eligible for 180 days of shared generic drug exclusivity. Mirabegron is indicated for the treatment of overactive bladder (OAB) and will be manufactured at the group’s formulation manufacturing facility at Ahmedabad SEZ, India. The approved drug had annual sales of US$2.42 billion in US (IQVIA MAT August 2022).
View:
Mirabegron is a potentially blockbuster drug for Zydus with big market and limited competition in first 180 days. Company is likely to benefit and gain double digit market share during shared exclusivity. Zydus has already guided for 30+ launches in FY23 and recent launches like Mirabegron, Cariprazine and gRevlimid bodes well for US business (~39% of top line).
Impact:
Positive.