The Office of Generic Drugs reports that it approved 64 applications that were designated for competitive generic therapy (GCT) program. Since its inception, the program has approved a total of 186 (2 thus far in 2023) applications with the GCT designation. For the 2022 FY, OGD approved 69 ANDA that had GCT designation.
Remember that all ANDA that receive a GCT designation are not always eligible for the 180-day exclusivity period that comes from the assigned designation. For instance, since CGT designation is made either prior to submission or at the time of submission, if a product has the CGT designation but a patent or exclusivity period is awarded to the reference listed drug (RLD) before the submission of the ANDA is made, the product is no longer eligible for CGT exclusivity.
The FDA website (here) describes the various factors associated with CGT-designated products including where they are eligible after submission, whether CGT exclusivity has been forfeited, and the date of first commercial marketing which would trigger the 180-day exclusivity period. See more about the CGT program here.
