NEW YORK Ranbaxy has won the right to sell a generic version of an Alzheimer’s disease drug made by Eisai, according to published reports.
Bloomberg reported Tuesday that the Indian drug maker had won 180 days’ exclusivity in which to market a generic version of Eisai’s Aricept (donepezil hydrochloride) tablets, pending final Food and Drug Administration approval, beating out Israel-based Teva Pharmaceutical Industries.
Under the Hatch-Waxman Act of 1984, the first company to file for approval for a generic drug gets 180 days in which to compete directly with the branded version. After that period, other generic companies can make their own versions.
Aricept had global sales of around $3.9 billion, according to Eisai financial data.