Teva Pharmaceutical Industries has received final approval from the US FDA for its generic versions of Merck’s anti-hypertensive agents Hyzaar (hydrochlorothiazide; losartan potassium) and Cozaar (losartan potassium).
Teva has been awarded 180-day Hatch-Waxman statutory exclusivity to market the products as it is the first company to file an abbreviated new drug application with the FDA that contained a paragraph IV certification.
Teva said on 2 March the US Court of Appeals for the District of Columbia Circuit has ruled in its favour by overturning a 31 July 2009 district court decision on the 180-day exclusivity.
According to IMS sales data, the products had combined annual sales of $1.6bn in the US.
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