Glenmark Pharmaceuticals (GPI) and Sun Pharmaceuticals have 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 about $643million 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.

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 and respiratory diseases) and metabolic disorders (diabetes and obesity). 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. Meanwhile, Sun Pharmaceuticals has also been granted USFDA approval for oxcarbazepine tablets."Sun Pharma, being one of the first-to-file an ANDA for generic Trileptal with a para IV certification, shares a 180-day marketing exclusivity. No action for patent infringement has been brought against Sun Pharma," the release added.