Taro files abbreviated NDA for generic Trileptal; Novartis to seek lawsuit

By Elaine Rigoli

Tampa, Fla., Sept. 8 - Taro Pharmaceutical Industries Ltd. has filed an abbreviated New Drug Application with the Food and Drug Administration for Oxcarbazepine tablets 150, 300 and 600 mg.

Oxcarbazepine tablets, currently marketed by Novartis as Trileptal (oxcarbazepine) tablets, are a prescription pharmaceutical product used in treating seizures.

Taro said its abbreviated NDA 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.

Taro is a science-based pharmaceutical company in Hawthorne, N.Y.

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