FDA grants tentative approval for Teva's generic Aricept

JERUSALEM The Food and Drug Administration has granted tentative approval to Teva for its application to market a generic version of Eisai’s Alzheimer's drug Aricept (donepezil hydrochloride).

Teva is currently in patent litigation concerning this product in the U.S. District Court for the District of New Jersey involving Teva's paragraph IV certification to U.S. Patent No. 4,895,841. Although a trial date has not been set, the court has set a briefing schedule for a preliminary injunction motion under which Eisai must file its request no later than Feb. 15. Final approval of this application is anticipated on or about April 26.

The drug, if approved, will be available in 5 mg and 10 mg tablets. The brand drug had annual sales of approximately $1.6 billion in the U.S. for the 12 months that ended Sept. 30, 2007, based on IMS sales data.