It depends on what type of exclusivity is at issue.
• Orphan Drug Exclusivity (ODE) – 7 years
• New Chemical Entity Exclusivity (NCE) – 5 years
• Generating Antibiotic Incentives Now (GAIN) Exclusivity– 5 years added to certain exclusivities
• New Clinical Investigation Exclusivity – 3 years
• Pediatric Exclusivity (PED) – 6 months added to existing Patents/Exclusivity
• Patent Challenge (PC) – 180 days (this exclusivity is for ANDAs only)
• Competitive Generic Therapy (CGT) – 180 days (this exclusivity is for ANDAs only)
See 21 C.F.R. 314.108, 316.31, 316.34 and sections 505A, 505E, 505(j)(5)(B)(iv), and Section 505(j)(5)(B)(v) of the FD&C Act.
