Product Launch Details
Lupin Limited announced the launch of its Azilsartan Medoxomil Tablets in the United States. The launch includes two dosage strengths: 40mg and 80mg.
Regulatory Approval and Equivalency
The product launch followed approval from the U.S. Food and Drug Administration (U.S. FDA) for Lupin's Abbreviated New Drug Application (ANDA). The product is bioequivalent to Edarbi®, a branded product from Azurity Pharmaceuticals, Inc.
Product Indication
The Azilsartan Medoxomil Tablets are indicated for the treatment of hypertension in adults to lower blood pressure.
Market Exclusivity and Financials
Lupin is the exclusive first-to-file for this product and is consequently eligible for 180-day generic drug exclusivity in the US market. The Reference Listed Drug (RLD) Edarbi® had estimated annual sales of USD 53.5 million in the U.S. (IQVIA MAT APRIL 2026).
Corporate Background
Lupin Limited is a global pharmaceutical company headquartered in Mumbai, India. Its products are distributed in over 100 markets. The company specializes in branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. It has a strong presence in the US and India across therapy areas including cardiovascular. The company operates 15 manufacturing sites and 7 research centers globally and has a workforce of over 24,000 professionals.
Trademark Notice
The announcement included a Safe Harbor Statement noting that Edarbi® is a registered trademark of Takeda Pharmaceutical Company, Ltd.