Novartis Garners Pediatric Exclusivity for Diovan

The FDA has granted Diovan pediatric exclusivity based on studies conducted in children with high blood pressure, Novartis announced.

This action extends the marketing exclusivity associated with the valsartan compound patent by six months — from March to September 2012 — the company said Aug. 10. Two other Diovan (valsartan) patents listed in the FDA Orange Book expire in October 2016 and June 2017.

Nearly 5 percent of U.S. children and adolescents may have high blood pressure, according to Novartis. The company added that it anticipates an FDA decision on adding a pediatric indication to Diovan’s labeling by the end of the year.

Diovan is Novartis’ top-selling brand drug, with $2.4 billion in sales during the first half of 2007, the company reported in its second-quarter earnings statement last month.