Sun Pharmaceutical Industries

Sun Pharmaceutical Industries Ltd has announced that USFDA has granted final approval for the Company's Abbreviated New Drug Application (ANDA) to market its generic version of Novartis Trileptal®, oxcarbazepine tablets.

These generic oxcarbazepine tablets are AB-rated equivalent of Novartis Trileptal® Tablets and include three strengths: 150 mg, 300 mg and 600 mg. These strengths of Trileptal® have annual sales of approximately USD 640 million in the US.

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.

Oxcarbazepinc is indicated for use as monotherapy or adjunctive therapy in the treatment of partial seizures.

The Company expects to reach the market shortly with these products.