What is Market Exclusivity in US?

Exclusivity refers to certain delays and prohibitions on approval of competitor drugs available under the statute that attach upon approval of a drug or of certain supplements. A new drug application (NDA) or abbreviated new drug application (ANDA) holder is eligible for exclusivity if statutory requirements are met.

exclusivity period 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)