Ranbaxy Gets Tentative Approval to Make Generic Aricept

NJBIZ STAFF//August 9, 2005//

Ranbaxy Gets Tentative Approval to Make Generic Aricept

NJBIZ STAFF//August 9, 2005//

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Ranbaxy Pharmaceuticals in Princeton received tentative approval from the Food and Drug Administration to make and market a generic version of Eisai’s Aricept (donepezil hydrochloride) tablets in 5 mg and 10 mg doses. The tentative approval will not be final before November 2010, when Eisai’s patent expires.

The drug is used for the treatment of dementia associated with Alzheimer’s. Aricept is jointly promoted by Pfizer and Eisai in Teaneck. Annual sales of Aricept in 5 mg and 10 mg doses were $935.3 million last year.