Knowledge Base
How long does an exclusivity period last in US?
5 January 2024
2 min read
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)
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