SEVERAL COMPANIES WIN APPROVAL FOR GENERIC ZOLOFT

A handful of drugmakers announced they have won FDA approval to market generic versions of Pfizer's antidepressant Zoloft. The companies include Mylan, Lupin, Roxane, Actavis, Pliva and Ranbaxy.

The companies received approval to manufacture and market sertraline hydrochloride tablets in dosages ranging from 25 mg to 200 mg.

Zoloft is indicated for the treatment of major depressive disorder, as well as social anxiety disorder, panic disorder and obsessive-compulsive disorder. The drug had total annual sales of approximately $2.9 billion for the 12 months ended December 2006, according to IMS Health data.

Teva Pharmaceutical Industries was the first company to win approval for generic Zoloft, and therefore the company enjoyed 180 days of marketing exclusivity, which ended last week. The company filed multiple infringement lawsuits against the competing generic firms relating to patents on the crystalline forms of sertraline hydrochloride and how it is manufactured.