Ranbaxy Pharmaceuticals Inc. has received final approval
from the FDA to manufacture and market Donepezil
Hydrochloride Tablets 5 mg and 10 mg with 180-day market exclusivity in the U.S. healthcare
system. Total annual market sales for Aricept 5 mg and 10 mg tablets were $2.6
billion (IMS-MAT: September 2010). Aricept is indicated for the treatment of
dementia of the Alzheimer’s type, and in patients with mild to moderate and severe
Alzheimer’s disease.
“We are pleased to announce the launch of Donepezil,
which expands Ranbaxy’s portfolio of affordable generic pharmaceuticals.
Ranbaxy’s generic formulation of Aricept will benefit the U.S. healthcare system by providing a more
affordable treatment option to patients, which will have a positive impact on
escalating U.S.
healthcare costs,” said Bill Winter, Vice President of Trade Sales, RPI.
According to the Alzheimer’s Association, 5.3 million
Americans of all ages have Alzheimer’s disease. “Since the incidence of
dementia has increased, while the costs associated with treating dementia
continue to rise, the launch of a generic formulation of Donepezil tablets will
provide patients with a cost effective alternative. The end result will be a
significant reduction in healthcare costs for those individuals suffering from
Alzheimer’s disease,” commented Arun Sawhney, Managing Director, Ranbaxy
Laboratories Ltd.
