Lupin Launches Azilsartan Medoxomil Tablets in U.S. Following FDA Approval

Lupin Launches Azilsartan Medoxomil Tablets in U.S. Following FDA Approval

Lupin Launches Azilsartan Medoxomil Tablets in U.S. Following FDA Approval​

Global pharmaceutical leader Lupin Limited has announced the successful launch of its Azilsartan Medoxomil Tablets (40mg and 80mg) in the United States, following approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application.

The product is indicated for the treatment of hypertension in adults to lower blood pressure. Lupin’s Azilsartan Medoxomil Tablets are bioequivalent to Edarbi® of Azurity Pharmaceuticals, Inc.

Lupin holds a key market position as the exclusive first-to-file for this medication and is eligible for 180 days of generic drug exclusivity in the U.S. market. According to estimations from IQVIA MAT (April 2026), the product was projected to achieve estimated annual sales of USD 53.5 million in the United States.

Lupin Limited, headquartered in Mumbai, India, is a global pharmaceutical entity with products distributed across over 100 markets. The company specializes in various pharmaceutical formulations, including branded and generic products, complex generics, biotechnology items, and active pharmaceutical ingredients. It maintains a strong presence in both India and the U.S. across several therapy areas such as cardiovascular, respiratory, and gastrointestinal health.

The company operates 15 state-of-the-art manufacturing sites and 7 research centers globally, supported by a workforce exceeding 24,000 professionals. Lupin is also committed to improving patient outcomes through its subsidiaries, including Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions.

LUPIN Stock Price Movement​

Lupin Limited shares slipped by 0.06% to settle at ₹2272 today, closing in lower territory after trading activity concluded. The stock saw a daily range between ₹2253.6 and ₹2284.3 on a total volume of 594,226 shares.
 

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