Global pharmaceutical company Lupin Limited has announced the launch of Azilsartan Medoxomil Tablets, 40 mg and 80 mg, in the United States after receiving approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA).

The product is a bioequivalent version of Edarbi (Azilsartan Medoxomil) marketed by Azurity Pharmaceuticals, Inc., and is indicated for the treatment of hypertension in adults to help lower blood pressure.

Lupin is the exclusive first-to-file applicant for the product and is eligible for 180 days of generic drug exclusivity in the U.S. market, providing the company with a significant commercial advantage during the exclusivity period.

According to IQVIA MAT data for April 2026, Edarbi recorded estimated annual sales of USD 53.5 million in the United States, highlighting the market opportunity for the generic version.

The launch further strengthens Lupin's U.S. generics portfolio and underscores the company's continued focus on expanding access to affordable treatment options for patients while enhancing its presence in the highly competitive U.S. pharmaceutical market.