Glenmark Pharmaceuticals

Glenmark Pharmaceuticals Ltd has announced that the Company has received final approval from the U.S. Food and Drug Administration for the marketing the first generic version of Trileptal (Oxcarbazepine). The approval is for marketing Oxcarbazapine tablets in three strengths - 150 mg, 300 mg and 600 mg.

The Company was one of the first ANDA applicants to submit a Paragraph IV certification to the '525 patent'. Therefore, with this approval, the Company has been awarded for 180 days of shared generic drug exclusivity for these strengths.

Trileptal is a widely used medication to treat epilepsy that has FDA approval.

Oxcarbazepine sales were approximately US$ 643 million, for the 12-month period ending June 30, 2007, according to IMS Health.

With this approval, GPI now has a portfolio of 20 generic products for the US market and has over 35 ANDAs undergoing US FDA approval process / launch.