Irbesartan and Irbesartan-Hydrochlorothiazide tablets are generic equivalents to Sanofi Aventis’ high blood pressure treatments, Avapro and Avalide tablets.
Teva has been granted a 180-day period of marketing exclusivity, as it is the first company to file abbreviated new drug applications containing paragraph IV certifications for the products.
The brand products had annual sales of approximately $464m and $124m, respectively, in the US, based on IMS sales data.