US regulatory authorities have granted final approval to Teva Pharmaceutical Industries to market the generic version of Novartis' Focalin tablets for ADHD.
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Teva is the first company to file a copycat version of Focalin for approval and, as a result, has been awarded a 180-day period of marketing exclusivity. The drug's generic name is dexmethylphenidate.
The branded product had annual sales of approximately $19 million for the 12 months ended September 2006, based on IMS sales data.
Teva is currently in patent litigation concerning this product in a US district court in New Jersey.