Lupin Limited (Lupin) has announced the launch of Azilsartan Medoxomil Tablets, 40mg and 80mg in the United States following the approval from the U.S. FDA 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 USD 53.5 million in the U.S. (IQVIA MAT APRIL 2026)