US FDA approves Sun Pharmaceutical'' version of Novartis''s Trileptal tablets for US sales

The US FDA has granted its final approval for Sun Pharmaceutical Industries'' 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 $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 with a "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.

Glenmark Pharmaceuticals Ltd has also received final US Food and Drug Administration approval for the marketing the first generic version of Trileptal (oxcarbazepine) also in three strengths - 150 mg, 300 mg and 600 mg. (See: Glenmark Pharmaceuticals to market epilepsy drug oxcarbazepine in the US)