Teva Pharmaceutical Industries Ltd. announced on March 14 that it has commenced commercial launch of escitalopram oxalate tablets, the company’s generic version of Forest Laboratories’ depression and generalized anxiety disorder treatment Lexapro tablets.
The branded product had annual sales of approximately $2.9 billion in the United States, based on IMS sales data. As the first company to file an abbreviated new drug application containing a paragraph IV certification for this product, Teva has been awarded a 180-day period of marketing exclusivity.
"These psychiatric conditions can be disabling and prevent a person from doing everyday activities," FDA Center for Drug Evaluation and Research director Janet Woodcock said. "This medication is widely used by people who must manage their condition over time, so it is important to have affordable treatment options."