Mumbai, India, Naples, Fla, June 17, 2026: Global pharma major Lupin Limited (Lupin) today 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).
Lupin Limited is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. Lupin specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. Trusted by healthcare professionals and consumers globally, the company enjoys a strong position in India and the U.S. across multiple therapy areas, including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women's health. Lupin has 15 state-of-the-art manufacturing sites and 7 research centers globally, along with a dedicated workforce of over 24,000 professionals. Lupin is committed to improving patient health outcomes through its subsidiaries - Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions.
To know more, visit www.lupin.com or follow us on LinkedIn at https://www.linkedin.com/company/lupin
Rajalakshmi Azariah
Vice President & Global Head – Corporate Communications, Lupin
rajalakshmiazariah@lupin.com
Elise Titan
Director – U.S. Communications, Lupin
elisetitan@lupin.com
Edarbi® is a registered trademark of Takeda Pharmaceutical Company, Ltd.
