The FDA has updated its list of all ANDA final approvals for drug products that have received CGT designation. The list cites a total of 150 ANDAs and the first approval under the program dates back to August 8, 2018.
So far in 2022, FDA has approved 29 such ANDAs, of which 10 have commenced commercial marketing which has triggered their 180-day period of exclusive marketing. The number of days from approval to first commercial marketing for the 10 ANDAs approved ranges from 0 (meaning launch was on the day of approval) to 61 days. Also, during that time, one applicant relinquished their right to CGT exclusivity but none of the applicants of these ANDA has forfeited CGT exclusivity to date. Of the 29 ANDAs approved in 2022 with CGT designation, 14 were not eligible because they were not the first product approved.
The FDA indicates that it “intends that the information on the list will provide transparency to prospective applicants and other interested parties with respect to the history of CGT designations for approved ANDAs and whether individual products qualified for CGT exclusivity. FDA believes that this information will be useful to help demonstrate the impact of the CGT provisions of the FD&C Act on encouraging development of drug products for which there was inadequate generic competition and will also aid generic applicants by identifying drug products for which CGT exclusivity has already been granted (as noted above, there is only one exclusivity period for each CGT).” They also note that providing the first commercial marketing date will help other sponsors realize that they were not first approvals under the program and provide information that will allow them to know what date they may be able to market the product because they are blocked by the CGT exclusivity period.
The full list of CGT product approvals and more information about the product’s status can be found here.
