Taro Pharmaceutical Industries Ltd. has settled a pending lawsuit with Novartis and will be launching Oxcarbazepine tablets 150 mg, 300 mg, and 600 mg in the United States.
Oxcarbazepine tablets, marketed by Novartis as Trileptal tablets, is a prescription pharmaceutical product used in treating seizures. Taro recently settled litigation with Novartis regarding Taro's "Paragraph IV" certification challenging Novartis' patent protection on Trileptal. On November 15, 2007, Taro received approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Oxcarbazepine Tablets 150 mg, 300 mg, and 600 mg. The litigated patent is US7037525 (Expiry 12-8-2018 with PED), which covers a method of treating seizures, which comprises administering a formulation of oxacarbazepine having improved bioavailability, wherein said oxacarbazepine consists essentially of oxacarbazepine having a maximum residue on a 40 .mu.m sieve of less than or equal to 5%.
The company did not immediately launch the product at that time, pending settlement of the litigation with Novartis. Taro plans to launch Oxcarbazepine tablets in the near future. According to industry sources, Trileptal tablets currently have annual U.S. sales of approximately $700 million.
Oxcarbazepine tablets, marketed by Novartis as Trileptal tablets, is a prescription pharmaceutical product used in treating seizures. Taro recently settled litigation with Novartis regarding Taro's "Paragraph IV" certification challenging Novartis' patent protection on Trileptal. On November 15, 2007, Taro received approval from the U.S. Food and Drug Administration for its Abbreviated New Drug Application for Oxcarbazepine Tablets 150 mg, 300 mg, and 600 mg. The litigated patent is US7037525 (Expiry 12-8-2018 with PED), which covers a method of treating seizures, which comprises administering a formulation of oxacarbazepine having improved bioavailability, wherein said oxacarbazepine consists essentially of oxacarbazepine having a maximum residue on a 40 .mu.m sieve of less than or equal to 5%.
The company did not immediately launch the product at that time, pending settlement of the litigation with Novartis. Taro plans to launch Oxcarbazepine tablets in the near future. According to industry sources, Trileptal tablets currently have annual U.S. sales of approximately $700 million.
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