TARO SUBMITS ANDA FOR OXCARBAZEPINE, CHALLENGES NOVARTIS' PATENT

Taro Pharmaceutical Industries has filed an abbreviated new drug application (ANDA) with the FDA for oxcarbazepine tablets, 150, 300 and 600 mg.

Oxcarbazepine, currently marketed by Novartis as Trileptal, is used for treating epileptic seizures. Taro's ANDA includes a Paragraph IV certification challenging Novartis' patent protection on Trileptal.

Under the process created by the Hatch-Waxman Act, Taro has notified Novartis of its patent challenge. Novartis, in turn, has initiated a lawsuit against Taro.