Lupin has launched Azilsartan Medoxomil Tablets, 40mg and 80mg in the US following the approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA). 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 USD 53.5 million in the US (IQVIA MAT April 2026).