Lupin rises over 3% after US FDA approves Mirabegron tablets

Lupin stocks surge: Pharmaceutical major Lupin shares rose as much as 3.39 per cent to hit an intraday high of Rs 1,599.50 per share on Monday. 

The surge came after the United States Food and Drug Administration (US FDA) on April 20, approved the launch of Lupin's Mirabegron extended-release (ER) tablets, 25 mg, in the United States.

Mirabegron is used alone or together with other medicines such as solifenacin succinate, to treat the symptoms of an overactive bladder (OAB). It is also used to treat neurogenic detrusor overactivity (NDO).

Mirabegron extended-release tablets, 25 mg is a generic equivalent of Myrbetriq extended-release tablets, 25 mg of Astellas Pharma Global Development, Inc., Lupin said in a statement. 

Mirabegron tablets had estimated annual sales of $1,019 million in the US, as per IQVIA MAT February 2024.

Headquartered in Mumbai, Lupin develops and commercialises a wide range of branded and generic formulations, biotechnology products, and active pharmaceutical ingredients (APIs) in over 100 markets in the US, India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions. 

Also, Lupin is the third-largest pharmaceutical company in the US by prescription. The company claims to have invested 7.9 per cent of its revenue in research and development (R&D) in the financial year 2023 (FY23). 

Lupin has 15 manufacturing sites, 7 research centres, more than 20,000 professionals working globally.

Last week, Lupin announced that the US FDA completed inspection of its Dabhasa facility with no observations.

The market capitalisation of Lupin is Rs 73,001.59 crore, according to BSE.

Notably, Lupin has zoomed 36.99 per cent in the past six months and is up 21.74 per cent year to date (YTD).

As of 9:36 am, shares of Lupin were trading 3.16 per cent higher at Rs 1,598, outperforming S&P BSE100, which was trading 0.52 per cent higher at 23,321.15 levels.