Glenmark Pharmaceuticals to market epilepsy drug oxcarbazepine in the US

Glenmark Pharmaceuticals Ltd has received final US Food and Drug Administration approval 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.

Glenmark says it was one of the first ANDA applicants to submit a Paragraph IV certification to the ''525 patent''. With this approval it has been awarded a 180-day shared generic drug exclusivity for these strengths.

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

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

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

The US FDA has also granted its final approval for Sun Pharmaceutical Industries'' abbreviated new drug application (ANDA) to market its generic version of Novartis Trileptal, oxcarbazepine tablets.(See:US FDA approves Sun Pharmaceutical'' version of Novartis''s Trileptal tablets for US sales)