Glenmark Pharmaceuticals has received final approval from the US Food and Drug Administration for the marketing oral tablets of Trileptal (Oxcarbazepine) of 150 mg, 300 mg and 600 mg. Oxcarbazepine tablets have an annual sale of approximately $643 million 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.The company was one of the first ANDA applicants to submit a Paragraph IV certification to the '525 patent'. GPI has been awarded 180 days of shared generic drug exclusivity for these tablets. Trileptal is a widely used medication to treat epilepsy that has FDA approval.GPI is focussed on discovery of new molecules in areas of inflammation (asthma/COPD, etc) and metabolic disorders (diabetes, obesity, etc). The company has generic formulation and API business interest in over 80 countries across the world including the highly regulated markets of US and Europe.The formulations business spans several product segments such as dermatology, internal medicine, paediatrics, gynaecology, ENT, diabetes and oncology.
