HAWTHORNE Taro announced Wednesday that it has settled a patent lawsuit with Novartis and will launch oxcarbazepine tablets, the generic version of Novartis’ Trileptal. Oxcarbazepine tablets are indicated to treat seizures.
The litigation with Novartis centered on Taro’s Paragraph IV certification challenging Novartis’ patent protection on Trileptal. On Nov. 15, 2007, Taro received Food and Drug Administration approval for its abbreviated new drug application for oxcarbazepine tablets in 150 mg, 300 mg and 600 mg strengths, but the company waited to launch the drug until the lawsuit was settled.
According to Taro, Trileptal currently has annual U.S. sales of approximately $700 million.