Ranbaxy, Teva Win Approval, Share Exclusivity for Generic Aricept

Ranbaxy Laboratories and Teva Pharmaceutical Industries have won FDA approval to market generic versions of Eisai’s blockbuster Alzheimer’s drug Aricept and will share 180-day exclusivity on the drug. The approvals were granted to the companies following the expiration of Eisai’s ’841 patent on Aricept (donepezil). Ranbaxy’s 180-day exclusivity will apply to its ANDA for donepezil 5- and 10-mg tablets, while Teva’s exclusivity, which was granted to its subsidiary Barr Pharmaceuticals, applies to its application for 5- and 10-mg orally disintegrating tablets, Crystal Rice, an FDA spokeswoman, said.
Washington Drug Letter