Lupin Launches Generic Dapagliflozin Tablets in the US Following FDA Approval
Lupin launches generic Dapagliflozin tablets in US after FDA nod
Business Standard
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Lupin has launched Dapagliflozin Tablets in the United States in 5 mg and 10 mg strengths after receiving approval from the U.S. Food and Drug Administration. This launch enhances Lupin's position in the oral anti-diabetic market and follows a significant increase in its profits and revenues in Q3 FY26.
- 01Lupin's Dapagliflozin Tablets are now available in the US market.
- 02The launch is a result of FDA approval of Lupin's abbreviated new drug application.
- 03Dapagliflozin is used to treat Type 2 Diabetes and related conditions.
- 04Lupin reported a 37.46% increase in net profit in Q3 FY26.
- 05Shares of Lupin have decreased by 0.88% following the announcement.
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Lupin, a leading global pharmaceutical company based in Mumbai, India, has launched Dapagliflozin Tablets in the United States, available in 5 mg and 10 mg strengths. This follows the approval of its abbreviated new drug application (ANDA) by the U.S. Food and Drug Administration (FDA). The product is a bioequivalent version of Farxiga and is indicated for treating Type 2 Diabetes, as well as certain cardiovascular and renal disorders. This launch signifies Lupin's strategic expansion in the U.S. generics market, particularly in the oral anti-diabetic segment. In its financial results for Q3 FY26, Lupin reported a remarkable 37.46% rise in consolidated net profit, reaching ₹1,175.55 crore (approximately $142 million USD), compared to ₹855.16 crore (approximately $103 million USD) in the same quarter the previous year. Total revenue from operations also saw a year-on-year increase of 24.26%, amounting to ₹7,167.52 crore (approximately $861 million USD). However, shares of Lupin have seen a slight decline of 0.88%, trading at ₹2,312.10 (approximately $28 USD) on the Bombay Stock Exchange (BSE).
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The launch of Dapagliflozin Tablets will provide more treatment options for patients with Type 2 Diabetes in the U.S., potentially influencing medication affordability and availability.
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