New Delhi: Drug major Ranbaxy on Tuesday said it has received final approval from the US health regulator to manufacture and market generic Donepezil Hydrochloride tablets used for treating Alzheimer’s disease with 180 days market exclusivity.
The approval for Donepezil Hydrochloride tablets has been given by US Food and Drug Administration (US FDA) in the strengths of 5 mg and 10 mg, company said in a filing to the Bombay Stock Exchange (BSE).
“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”, Ranbaxy Laboratories managing director Arun Sawhney said.
“The end result will be a significant reduction in healthcare costs for those individuals suffering from Alzheimer’s disease”, he added.
Donepezil Hydrochloride tablets are generic of Aricept tablets in the strengths of 5 mg and 10 mg. According to IMS Health, total annual market sales for Aricept tablets were $2.6 billion.
“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”, Ranbaxy Pharmaceuticals Inc vice president of Trade Sales Bill Winter said.
Ranbaxy share was today trading at Rs 571.50 on the BSE in the afternoon trade, up by 1.02% from its previous close.