Lupin Limited (Lupin) the Indian Global pharmaceuticals major announced that the company will launch Azilsartan Medoxomil Tablets, 40mg and 80mg in the United States, which got approval from the U.S. byAbbreviated New Drug Application (ANDA).
This is a bioequivalent product of Edarbi® produces byAzurity Pharmaceuticals, Inc. and primarily used in the treatment of hypertension in adults to lower blood pressure. Lupin has entered the market as the exclusive first applicant for the product and has secured 180 days of generic drug exclusivity in the United States. The exclusivity period gives the company a significant commercial advantage while reinforcing its strategy of introducing complex and high-value generic medicines across major global markets.
According to IQVIA MAT April 2026 report AzilsartanMedoxomil Tablets (RLD Edarbi®) had estimated annual sales of USD 53.5 million in the U.S. In addition, Lupin holds a competitive position in the U.S. generics market, and this launch further strengthens its presence in cardiovascular therapies.
The launch reflects Lupin’s ongoing focus on expanding access to quality medicines through timely commercialization of FDA-approved generic products. Over the years, the company has built a strong regulatory and manufacturing platform that enables it to bring affordable treatment alternatives to patients while supporting healthcare systems with cost-effective pharmaceutical solutions.
Headquartered in Mumbai, Lupin is among the world’s leading pharmaceutical companies, with products marketed in more than 100 countries. The company maintains a diversified portfolio that includes branded and generic formulations, complex generics, biotechnology products and active pharmaceutical ingredients. It has established a strong presence across several therapeutic areas, including cardiovascular care, respiratory medicine, diabetes management, anti-infectives, gastroenterology, central nervous system disorders and women’s health.
Written by: Pramit Hazra
Graphics by: Pramit Hazra
