What does 42 minutes mean for Competitive Generic Therapies (CGT) exclusivity – apparently everything, when FDA approved another product 42 minutes before commercial marketing began for the first approved applicant. We don’t know for sure if it was 42 minutes (evidence of first commercial distribution) or actually 5 hours and three minutes (when the first approved applicant for potassium chloride actually notified the FDA of its commercial marketing through the FDA’s electronic gateway) but the time window is really not relevant, because the FDA approved a second applicant prior to either event!
The CGT exclusivity trigger, as explained in the FDA’s Denial-Request to rescind approval of ANDA 209786 letter (here) rests on the notice of first commercial marketing; the FDA notes in its letter that the only applications blocked by CGT exclusivity are those that are subsequent to that first commercial marketing notification.
Take time to read the letter carefully, as it outlines in detail the CGT provisions and discusses the nuances of the difference between CGT exclusivity and 180-day first-to-file exclusivity. It also discusses the difference between CGT exclusivity forfeiture and how it is different from the result in this case. What is clear is that, for CGT exclusivity, minutes and timing clearly matter! Let this case be a lesson to anyone that obtains CGT designation, that notice of commercial marketing is the key and getting to market once approval is obtained is critical to avoid another such situation – after all, the CGT exclusivity was a stimulus to get such products to market as fast as possible. It will be interesting to see if the eligible party for CGT exclusivity will take further action relative to the Agency’s decision.