FDA recently awarded new chemical entity (NCE) exclusivity to Austedo™ (deutetrabenazine). The Austedo approval is notable for two reasons: One, it is the first deuterated drug (i.e., a drug containing the stable isotope —...more
The prior approval of a drug containing an active ingredient of the innovator drug is not necessarily a death knell for NCE exclusivity.
Originally published in the Intellectual Property and Life Sciences sections of...more