Under the Generating Antibiotic Incentives Now (GAIN) Title VIII of the FDA Safety and Innovation Act (FDASIA), at the time of approval FDA will grant an additional five years to certain exclusivity periods for products that have been granted a Qualified Infectious Disease Product (QIDP) designation.
QIDP designation is for medications intended to treat serious or life-threatening infections. This mostly covers antibiotics.
This status makes new drugs eligible for at least 5 years of exclusivity in the US.
- As part of this QIDP designation, FDA’s review of the drug application was expedited.
- The designation also qualified the drugs for five years of marketing exclusivity to be added to certain exclusivity already provided by the Food, Drug, and Cosmetic Act.