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Lupin Gets A Green Light From US-FDA: Know What The Product Is and What Market Think?

Lupin stock soared to 3.5% as the pharmaceutical company got approval from the Food and Drug Administration (US FDA) for the launch of a drug in the United States.

The Pharmaceutical major has announced the launch of Mirabegron Extended-release tablets of 25mg in The United States Market, The company has said that they have introduced this medication after receiving approval from the US Food and Drug Administration.

What are Mirabegron Extended-Release Tablets?

Mirabegron is a medication which helps in treating an overactive bladder and wetting accidents. Mirabegron Extended-Release tablet is a generic equivalent of Myrbetriq Extended-Release tablets of Astellas Pharma Global Development, Inc. The tablets are a medication used to treat overactive bladder (OAB) symptoms, such as frequent or urgent urination and urinary incontinence. This medication works by relaxing a certain bladder muscle called a detrusor.

About Lupin Ltd

The pharma major, Headquartered in Mumbai manufactures and sells a variety of branded and generic medications, as well as Active Pharmaceutical Ingredients (APIs).

In the US, Lupin ranks as the third-largest pharmaceutical company by prescriptions. In FY23, Lupin invested around 8% of its revenue in research and development.

Lupin has 15 manufacturing sites and 7 research centres globally, with a workforce of over 20,000 professionals.

The Company has its products available in more than 100 markets, including the US, India, South Africa, and regions across Asia Pacific (APAC), Latin America, Europe, and the Middle East. Lupin focuses on cardiovascular, anti-diabetic, and respiratory medications and also operates in areas like anti-infective, gastrointestinal (GI), central nervous system (CNS), and women’s health.

Market of Mirabegron Extended-Release Tablets in The United States

The Mirabegron Extended-Release tablets had estimated annual sales of $1,019 million in the US (according to IQVIA MAT February 2024), which means around Rs.8500 crores. With approval from FDA Lupin will now be entering this market with their medicine.

How Has The Market Reacted?

The shares of Lupin surged around 3.5% on Monday, 22nd April trading at Rs.1600 after this news, The markets have reacted positively to the company launching a new medicine in the US market, The stock has given an attractive multi-bagger return of around 128% in the past 1 year and has made a 52 week of Rs.1704.25.


After launching in the US market and getting approval from the FDA, Lupin is set to enter the US market for Mirabegron Extended Release Tablets and this will also give a rise in revenues for the pharma company ahead.

Disclaimer: This post has been written exclusively for educational purposes. The securities mentioned are only examples and not recommendations. It is based on several secondary sources on the internet and is subject to changes. Please consult an expert before making related decisions.