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FDA reminds first applicants to notify agency when commercial marketing begins for 180-day and CGT exclusivity
Summary
Strandberg said first applicants claiming 180-day patent-challenge exclusivity must notify FDA within 30 days of commercial marketing, and first approved applicants with CGT designation must commence marketing within 70 days of approval or forfeit exclusivity; FDA recommends same-day email and end-of-file correspondence to document marketing start.
Heather Strandberg reviewed how commercial marketing timing affects two types of 180-day exclusivity: patent-challenge (first applicant) and Competitive Generic Therapy (CGT) exclusivity (first approved applicant). She said a first patent-challenge applicant "must provide FDA with notice within 30 days of commercial marketing," and warned that notice received after 30 days will cause FDA to deem the date of first commercial marketing to be the product's approval date.
Regarding CGT exclusivity, Strandberg said the first approved applicant must start marketing within 70 days of approval or forfeit the exclusivity. "Marketing must commence within 70 days of the approval date, and if not, the exclusivity is forfeited," she said. To help FDA track marketing starts, she recommended contacting FDA on the same day marketing begins by emailing the patent-exclusivity email box and sending correspondence to the end of the file.
