Contains the same active ingredient as an originator's existing, licensed medicine although it may be of a different strength and/or presentation. It can be licensed and sold only when the originator's patent and licensing exclusivity have expired and must be labelled with an approved name or a brand name ("branded generics").

a copy of a brand name medicine

a copy that is identical to a brand name in dosage, safety, strength, how it is taken, quality, performance and intended use

an equivalent of an originator pharmaceutical product

a therapeutically equivalent drug as determined by the FDA