MORRISTOWN, N.J. — Drug maker Watson Pharmaceuticals said it has filed a regulatory approval application for a generic painkiller, challenging the patent that covers the branded version.
Watson announced Tuesday that it had filed an application with the Food and Drug Administration seeking approval for hydromorphone hydrochloride extended-release tablets in the 8-mg, 12-mg and 16-mg strengths. The drug is a generic version of Mallinckrodt’s Exalgo.