Lupin Limited has expanded its cardiovascular portfolio in the United States with the commercial launch of Azilsartan Medoxomil Tablets in 40 mg and 80 mg strengths following approval from the US Food and Drug Administration (FDA). The launch strengthens the company’s presence in the U.S. generics market while providing patients with a more affordable treatment option for hypertension.
The newly introduced tablets are the generic equivalent of Edarbi®, marketed by Azurity Pharmaceuticals, and are indicated for the treatment of high blood pressure in adults. Effective management of hypertension is essential for lowering the risk of serious cardiovascular conditions, including heart attack, stroke and kidney disease.
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 data for the twelve months ending April 2026, annual US sales of the reference product were estimated at approximately US$53.5 million. The market opportunity, combined with Lupin’s first-to-file status, is expected to strengthen the company’s position in the cardiovascular therapeutics segment and support continued growth in its US business.
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.
Lupin supports its global operations through an extensive manufacturing and research network comprising 15 manufacturing facilities and seven research and development centres worldwide. Backed by a workforce of more than 24,000 professionals, the company continues to invest in innovation, regulatory excellence and product development to address evolving healthcare needs.
