Sun Pharmaceutical Industries Ltd., a Rs.4100 crore plus Vadodara-based pharma company, has received US FDA tentative approval for an Abbreviated New Drug Application (ANDA) to market a generic version of Aricept, donepezil hydrochloride tablets.
These generic donepezil hydrochloride tablets, equivalent to Eisai's Aricept tablets, include two strengths: 5 mg and 10 mg. Annual sale in US for these strengths is approximately $ 2.5 billion.
Donepezil hydrochloride tablets are indicated in the treatment of dementia of the Alzheimer's type. Efficiency has been demonstrated in patients with mild, moderate and severe Alzheimer's disease.