Taro Pharmaceutical Industries Ltd. has filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration for Oxcarbazepine tablets 150, 300 and 600 mg (oxcarbazepine tablets).
Oxcarbazepine tablets, currently marketed by Novartis as Trileptal (oxcarbazepine) tablets, are a prescription pharmaceutical product used in treating 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, which is a standard practice in Paragraph IV patent challenges.
Taro Pharmaceutical Industries Ltd. is a multinational, science-based pharmaceutical company, dedicated to meeting the needs of its customers through the discovery, development, manufacturing and marketing of the highest quality healthcare products.