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Lupin launches generic Azilsartan Medoxomil tablets in U.S.

Lupin has launched Azilsartan Medoxomil Tablets, the generic version of Edarbi, for the treatment of hypertension and will receive 180 days of market exclusivity as the first-to-file applicant.

NAPLES, Fla. — Lupin Pharmaceuticals has launched Azilsartan Medoxomil Tablets in the United States following FDA approval of its abbreviated new drug application (ANDA).

The company said the product, available in 40 mg and 80 mg strengths, is bioequivalent to the hypertension treatment Edarbi and is indicated to lower blood pressure in adults with hypertension.

Lupin is the exclusive first-to-file applicant for the generic version and is eligible for 180 days of generic drug exclusivity in the U.S. market.

According to IQVIA data cited by the company, U.S. sales of the reference product totaled approximately $53.5 million for the 12 months ended April 2026.

Lupin, headquartered in Mumbai, India, markets pharmaceutical products in more than 100 countries and maintains a significant presence in the cardiovascular, respiratory, diabetes, anti-infective and women's health segments.

To know more, visit www.lupin.com or follow us on LinkedIn https://www.linkedin.com/company/lupin

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