Lupin Limited has launched Azilsartan Medoxomil Tablets in 40mg and 80mg strengths in the United States. The company received approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application, enabling the product's entry into the U.S. generic market.
The tablets are bioequivalent to Edarbi® of Azurity Pharmaceuticals, Inc. and are 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, which provides a period of market exclusivity for the first generic applicant to file an ANDA.
Azilsartan Medoxomil Tablets had estimated annual sales of approximately USD 53.5 million in the U.S. market, based on IQVIA MAT data for the twelve months ending April 2026.
Lupin Limited is a global pharmaceutical company headquartered in Mumbai, India, with products distributed in over 100 markets worldwide. Lupin specializes in branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. Lupin holds a strong position across therapy areas including cardiovascular, respiratory, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women's health.
Lupin operates 15 manufacturing sites and 7 research centers globally, employing more than 24,000 professionals. Its subsidiaries include Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions, focusing on diagnostics, digital health, and contract manufacturing.
Lupin has a strong presence in India and the United States across multiple therapy areas. The cardiovascular segment is a key focus, and the Azilsartan Medoxomil Tablets launch expands the product offerings in hypertension treatment.
Disclaimer: This article is based on company filings submitted to the Bombay Stock Exchange (BSE) and National Stock Exchange of India (NSE) and is for informational purposes only. It does not constitute investment advice or a recommendation. Investors should conduct their own research and consult a qualified financial advisor before making investment decisions.