Ranbaxy Pharmaceuticals Inc (RPI)., a wholly owned subsidiary of Ranbaxy Laboratories, has received final approval from the US FDA to manufacture and market donepezil hydrochloride tablets 5 mg and 10 mg with 180 day market exclusivity in the US. Total annual market sales for Aricept 5 mg and 10 mg tablets were $2.6 billion as per IMS-MAT). 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 US healthcare system by providing a more affordable treatment option to patients which will have a positive impact on escalating US healthcare costs."
Arun Sawhney, managing director, Ranbaxy Laboratories, said, "Since the incidence of dementia has increased, while the costs associated with treating dementia continue to rise, the launch of 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 Alzhemier's disease.
RPI, based in Jacksonville, Florida, USA, is engaged in the sale and distribution of generic and branded prescription products in the US healthcare system.