Indian drug major Lupin Limited has announced the launch of Azilsartan Medoxomil Tablets, 40mg and 80mg in the United States following the FDA approval for its Abbreviated New Drug Application.
The product is bioequivalent to Edarbi of Azurity Pharmaceuticals, and indicated for the treatment of hypertension in adults to lower blood pressure.
The Mumbai-headquartered Lupin is the exclusive first-to-file for this product and is eligible for 180-day generic drug exclusivity.
According to IQVIA MAT APRIL 2026 data, Azilsartan Medoxomil Tablets (RLD Edarbi) had estimated annual sales of $53.5 million in the US.
