The FDA has updated its first-generic approvals list for calendar year 2021 (here). The report is current through August 31, 2021 and lists a total of sixty-eight first-time approvals. As the FDA explains, “First generics are just what they sound like—the first approval by FDA which permits a manufacturer to market a generic drug product in the United States. FDA considers first generics to be important to public health, and prioritizes review of these submissions.”
Calendar year 2020 saw seventy-two first-time generics approved and the big year over the last five was 2019, with 107 first-time generics. Remember, though, if the date of a first approval coincides with the expiration of a patent or period of market exclusivity, there could be multiple approvals for the same product on that same day. The FDA counts each of these as a first approval so, when looking at the raw numbers, the absolute number of unique entities is usually lower than the total first generics reported.
