Lupin launches generic hypertension drug in US after regulatory nod

Mumbai-based pharmaceutical company Lupin Ltd on Wednesday announced the launch of Azilsartan Medoxomil Tablets in the United States after receiving approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA).

The company has launched the tablets in 40 mg and 80 mg strengths. The drug is indicated for the treatment of hypertension in adults and is used to help lower blood pressure.

Lupin said the product is bioequivalent to Edarbi, marketed by Azurity Pharmaceuticals. The company is also the exclusive first-to-file applicant for the generic version, making it eligible for 180 days of generic drug exclusivity in the US market.

According to IQVIA data cited by Lupin, Edarbi recorded estimated annual sales of $53.5 million in the United States during the 12 months ended April 2026.

The launch adds to Lupin's recent momentum in the US generics market. On May 29, the company received USFDA approval for its abbreviated new drug application for Sodium Sulfate, Magnesium Sulfate and Potassium Chloride Tablets, a generic version of Sutab tablets marketed by Azurity Pharmaceuticals.

Lupin had said it was the exclusive first-to-file applicant for that product as well, making it eligible for another 180-day exclusivity period. The tablets will be manufactured at the company's facility in Nagpur.

The pharmaceutical major expects its US business to remain above the $1 billion mark in FY27, supported by products such as Tolvaptan, Mirabegron and recently launched injectables.

Earlier, Chief Executive Officer Vinita Gupta said biosimilars and specialty products are expected to become increasingly important growth drivers for the company over the coming years.

Meanwhile, Executive Director and Global CFO Ramesh Swaminathan said Lupin expects margins to remain around 25% for the full year, supported by strong performance from key products, although higher freight costs and potential competition in major US products could weigh on profitability.

Shares of Lupin Ltd ended at ₹2,276.50 on the NSE on June 17, down 0.06% from the previous close.

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