Company Watch

US FDA nod for Glenmark and Sun's generic Trileptal

Our News Bureau - Mumbai

Glenmark Pharmaceuticals and Sun Pharma have received final approval from the USFDA for marketing the first generic version of Trileptal (Oxcarbazepine) tablets in three strengths of 150 mg, 300 mg and 600 mg. The two companies, along with Roxane Laboratories, submitted a Paragraph IV certification to the '525 patent' and were awarded 180 days of shared generic drug exclusivity for these strengths. Trileptal/Oxcarbazepine is widely used as a monotherapy or adjunctive therapy to treat epilepsy/partial seizures, approved by the FDA. Oxcarbazepine sales were approximately $643 million, for the 12-month period ending June 30, 2007, according to IMS Health. With this approval, Glenmark now has a portfolio of 20 generic products for the US market and has over 35 ANDAs undergoing US FDA approval process/launch.