India-based global pharmaceutical company Lupin Limited (BSE:500257) (NSE:LUPIN) announced on Thursday the launch of Azilsartan Medoxomil Tablets, 40mg and 80mg in the United States following US FDA approval of its Abbreviated New Drug Application.
The product is bioequivalent to Azurity Pharmaceuticals Inc's Edarbii, and is indicated for the treatment of hypertension in adults to lower blood pressure.
Lupin says that it is the exclusive first-to-file for this product and is eligible for 180-day generic drug exclusivity.
Azilsartan Medoxomil Tablets (RLD Edarbi) had estimated annual sales of USD53.5m in the US (IQVIA MAT April 2026)
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