Lupin jumps 4.5% as pharma firm gets US FDA nod for new drug to treat overactive bladder

Lupin share price jumped nearly 4.5 per cent to Rs 682 per share levels on the BSE and NSE intraday, respectively, during Friday’s trading session, after the company received USFDA (United States Food and Drug Authority) approval for Mirabegron Tablets or Generic Myrbetrig. 

Pharmaceutical major Lupin in its exchange filing announced, “The company has received approval from the USFDA for its Abbreviated New Drug Application (ANDA), Mirabegron Extended-Release Tablets, 25 mg, and 50 mg, to market a generic equivalent of Myrbetriq® Extended-Release Tablets, 25 mg and 50 mg, of Astellas Pharma Global Development, Inc.”  

The product will be manufactured at Lupin’s facility in Nagpur, according to the filing. 

Mirabegron Extended-Release Tablets, 25 mg and 50 mg, (RLD Myrbetriq®) had estimated annual sales of USD 2403 million in the U.S. (IQVIA MAT June 2022), the filing said. 

Mirabegron tablets are used as a medicine that eases the symptoms of an overactive bladder. 

The pace of USFDA inspections is already increasing in the US, domestic brokerage firm Motilal Oswal said, expecting that the number of USFDA inspections to improve gradually in geographies other than the US as well. 

India had 38 USFDA inspections over the past 12 months, with 18 sites awaiting citation from the USFDA, the brokerage said. “Regulatory compliance from the USFDA continues to pose a risk to Indian Pharma companies having an exposure to US Generics, with 60 official action indicated (OAI) citations yet to be resolved.” 

Centrum Broking expects the Indian Pharma sector to continue its strong growth trajectory ahead on a disrupted base. The IPM is expected to report ~10-12% growth in FY23, and it expects US sales to normalise in H2FY23, with recovery in wave three followed by improvement in inventories.  

The brokerage maintained a positive stance on the sector and remain optimistic while giving an Add rating for Lupin with a target price of Rs 700 per share.