Lupin Launches Generic Mirabegron Tablets in U.S. Market

On September 4, 2024, Lupin Limited, a global pharmaceutical company, announced the launch of its Mirabegron Extended-Release Tablets, 50 mg, in the United States. This product received approval from the U.S. Food and Drug Administration (U.S. FDA).

The tablets are a generic version of Astellas Pharma’s Myrbetriq® Extended-Release Tablets, 50 mg. As of July 2024, Mirabegron Extended-Release Tablets, 50 mg, had estimated annual sales of $1.6 billion in the U.S.

In their recent press release on August 8, 2024, Lupin Ltd’s wholly owned subsidiary, Generic Health Pty Ltd, incorporated Lupin NZ Ltd. in New Zealand. Lupin NZ, a new entity in the pharmaceutical sector, was created with a cash investment of NZD 5,00,000. It is fully owned by Generic Health and has not yet started operations.

Financial Highlights

In Q1 FY2025, the company reported a gross profit of ₹37,697 million, an increase from ₹33,213 million in Q4 FY2024, with a gross margin of 68.4%. Personnel costs amounted to ₹9,710 million, or 17.6% of sales, compared to ₹9,002 million in the previous quarter.

The Profit Before Tax (PBT) for the quarter was ₹9,930 million, reflecting an 18% rise due to improved performance and a ₹2,013 million impairment charge in Q4 FY2024. The company invested ₹3,500 million in Research and Development (R&D), which is 6.3% of sales. As of June 30, 2024, the company’s operating working capital was ₹61,686 million, and capital expenditure for the quarter was ₹1,117 million.

About Lupin Limited

Lupin Limited is a major global pharmaceutical company based in Mumbai, India, and operates in over 100 markets. The company offers a range of products, including branded and generic medicines, complex generics, biotechnology products, and active pharmaceutical ingredients. Known for its strong presence in India and the U.S., Lupin is active in areas such as respiratory, cardiovascular, diabetes, infections, gastrointestinal issues, central nervous system disorders, and women’s health. Lupin has 15 advanced manufacturing sites and 7 research centres worldwide, with a team of over 22,000 employees.

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