Ranbaxy Pharmaceuticals Inc., a wholly owned subsidiary of Ranbaxy Laboratories Limited (RLL), announced that RLL has received final approval from the U.S. 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 5mg and 10mg 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.
Bill Winter, Vice President of Trade Sales, RPI. said, 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 US healthcare costs.
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.