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Lupin launches Azilsartan Medoxomil tablets in United States

18 Jun 2026 Evaluate

Lupin has launched Azilsartan Medoxomil Tablets, 40mg and 80mg in the United States following the approval from the United States Food and Drug Administration (USFDA) for its Abbreviated New Drug Application. The product is bioequivalent to Edarbi of Azurity Pharmaceuticals, Inc. and 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.

Azilsartan Medoxomil Tablets (RLD Edarbi) had estimated annual sales of $53.5 million in the U.S. (IQVIA MAT APRIL 2026)

Lupin is an innovation led transnational pharmaceutical company producing, developing and marketing a wide range of branded and generic formulations, biotechnology products and active pharmaceutical ingredients (APIs) globally.


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