The FDA
Reauthorization Act of 2017 has 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. This new 180-day exclusivity, under 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.
This report forecasts the upcoming eligible CGT exclusivity drugs between 2025-2028 and generic manufacturers targeting those drugs. The report is prepared from our GenUS database.