Ranbaxy, which is part of the Japanese Daiichi Sankyo Group, announced that it had received final approval from the FDA to manufacture and market donepezil hydrochloride tablets 5 and 10 mg, giving the company 180-day market exclusivity for being first to market in the US.

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. According to the Alzheimer’s Association, 5.3 million Americans have Alzheimer’s disease.

Aricept is the best-selling medicine in the Alzheimer’s disease market. Annual sales for Aricept 5 and 10 mg tablets were US$2.6 billion in 2010, so the 180-day market exclusivity is a major result for Ranbaxy.

Vice President of Trade Sales at Ranbaxy, Mr Bill Winter, said “we are pleased to announce the launch of donepezil, which … will benefit the US healthcare system by providing a more affordable treatment option to patients [and] which will have a positive impact on escalating US healthcare costs”.