How long is exclusivity granted for?
It depends on what type of exclusivity is 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 ANDAs only) See 21 C.F.R. 314.108 New Drug Product Exclusivity.
Related Questions
- What credit is granted for work completed in a Dental Assistant program or previous work experience in a dental field?
- For approved drugs, must FDA approve a supplemental application before pediatric exclusivity is granted?
- How is an NDA holder notified if their application is granted exclusivity by the FDA?
