Competitive Generic Therapy (CGT) list

FDA Reauthorization Act of 2017 (FDARA) created a new type of 180-day exclusivity, different from 180-day patent challenge exclusivity, for the first approved applicant of a drug with a CGT designation for which there were no unexpired patents or exclusivities listed in the Orange Book at the time of original submission of the ANDA. 

According to FDA, this new 180-day exclusivity under FDARA (CGT exclusivity) is intended to incentivize competition for drugs that are not protected by patents or exclusivities and for which there is inadequate generic competition. 

Below list contains all the products that have received CGT exclusivity till date. The list was last updated on 19 January 2020. 

CGT EXCLUSIVITY TRACKER

USFDA Draft guidance on competitive generic therapy (CGT) is available here