Pharmaceutical Business review

Teva receives FDA approval for copycat Focalin tablets

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.