What is the difference between authorized generics and other generic products?
Other generic products are approved following submission by the generic manufacturer of an Abbreviated New Drug Submission, which relies on a bioequivalence study between the generic and the brand name, and the innovator’s safety and efficacy data in their original NDS. This process allows a generic company to obtain approval to market a generic version of the innovator product. An authorized generic is the innovator’s prescription drug, originally approved through a New Drug Submission (NDS) by Health Canada, marketed and distributed by an authorized generic distributor like Patriot with a generic product label.
