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Lupin has launched Azilsartan Medoxomil Tablets in US following the approval from the USFDA for its ANDA

ICICIdirect Research 18 Jun 2026 DISCLAIMER

News: Lupin has launched  Azilsartan Medoxomil Tablets in US following the approval from the USFDA for its ANDA. The product is bioequivalent to Edarbi of Azurity Pharma and is indicated for the treatment of hypertension in adults to lower blood pressure. Lupin is the exclusive first-to-file for this product and is eligible for 180-day generic drug exclusivity. The drug had estimated annual sales of US$ 53.5 million in the US as per IQVIA MAT April 26.

View: While the addressable market is relatively modest, we believe the 180-day exclusivity period and niche nature of the product should support attractive margins and meaningful market share gains. The launch also reinforces Lupin's presence in the cardiovascular segment and strengthens its U.S. specialty generics portfolio.

Impact: Positive

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