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.
Go deeper with GlobalData
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.
How well do you really know your competitors?
Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.
Thank you!
Your download email will arrive shortly
Not ready to buy yet? Download a free sample
We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form
By GlobalData
