Breckenridge Pharmaceutical has said that it has settled paragraph IV litigation with Novartis concerning Trileptal and that the FDA has approved Breckenridge's abbreviated new drug application for oxcarbazepine 150mg, 300mg and 600mg tablets in the US.
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Breckenridge has completed a shared 180-day exclusivity period and will immediately launch oxcarbazepine tablets 150mg, 300mg, and 600mg. Oxcarbazepine tablets are AB rated to Trileptal which is being used in treating seizures.
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