Lupin Limited has announced the launch of Azilsartan Medoxomil Tablets, 40mg and 80mg, in the United States. This launch follows U.S. FDA approval and makes Lupin the exclusive first-to-file for this product, eligible for 180-day generic drug exclusivity. The product is indicated for hypertension and had estimated annual sales of USD 53.5 million in the U.S. prior to this launch.
Lupin Launches New Hypertension Treatment in US Market
Lupin Limited, a global pharmaceutical leader, today announced the successful launch of its Azilsartan Medoxomil Tablets, available in 40mg and 80mg strengths, in the United States. This significant market entry follows the U.S. Food and Drug Administration’s (FDA) approval for its Abbreviated New Drug Application (ANDA).
Exclusive First-to-File Status and Market Potential
The newly launched Azilsartan Medoxomil Tablets are bioequivalent to Edarbi® of Azurity Pharmaceuticals, Inc. and are prescribed for the treatment of hypertension in adults. Lupin holds the distinction of being the exclusive first-to-file for this product, which grants it eligibility for 180-day generic drug exclusivity. This exclusivity period is a key strategic advantage for Lupin in the U.S. market. According to IQVIA data from April 2026, the product (under its reference drug, Edarbi®) had estimated annual sales of USD 53.5 million in the United States.
About Lupin’s Global Presence
Headquartered in Mumbai, India, Lupin Limited operates in over 100 markets worldwide. The company specializes in a broad spectrum of pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. Lupin has established a strong presence in both India and the U.S., catering to multiple therapeutic areas such as respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women’s health. The company boasts 15 state-of-the-art manufacturing sites and 7 research centers globally, supported by a workforce of over 24,000 professionals.
Commitment to Improving Patient Health
Lupin is dedicated to enhancing patient health outcomes through its various subsidiaries, including Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions. The company’s commitment to innovation and accessibility in healthcare continues to drive its global expansion and product development initiatives.
Source: BSE
