Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and may run concurrently with a patent but need not do so. Exclusivity is granted to a new drug applicant if statutory requirements are met. In case of pediatric exclusivity, a 6-month period of exclusivity is added to all existing patents and exclusivity on all applications held by the sponsor for that active moiety. Pediatric exclusivity does not stand alone, but attaches to existing exclusivity.
The length of exclusivity depends on the type of exclusivity granted:
- Orphan Drug (ODE) – 7 years
- New Chemical (NCE)- 5 years
- “Other” Exclusivity – 3 years for a “change” if criteria are met
- Pediatric Exclusivity (PED) – 6 months added to existing Patents/Exclusivity
- Patent Challenge – (PC) – 180 days (this exclusivity is for Abbreviated New Drug Applications (ANDAs only)