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Teva receives FDA approval for copycat Focalin tablets

US regulatory authorities have granted final approval to Teva Pharmaceutical Industries to market the generic version of Novartis' Focalin tablets for ADHD.

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.