Exclusivity Period
A period of market protection granted by the FDA (separate from patents) during which generic competitors cannot be approved — even if no patent exists.
How It Works
FDA exclusivity is different from patent protection. Key exclusivity types include: New Chemical Entity (NCE) exclusivity — 5 years for entirely new drugs; Orphan Drug Exclusivity — 7 years for drugs treating rare diseases; Pediatric Exclusivity — an additional 6 months for conducting pediatric studies; and New Clinical Investigation exclusivity — 3 years for new uses of approved drugs. A drug can have both patent protection and FDA exclusivity, and whichever lasts longer determines when generics can enter. Exclusivity periods are listed in the FDA Orange Book alongside patent information.
Related Terms
- Patent Expiration — The date when a drug's patent protection ends, allowing generic or biosimilar manufacturers to produce competing versions.
- FDA Approval — The process by which the U.S. Food and Drug Administration evaluates a drug's safety and efficacy through clinical trial data before allowing it to be marketed.
- Abbreviated New Drug Application (ANDA) — The FDA application pathway for generic drugs, which requires proving bioequivalence to the brand-name drug rather than repeating full clinical trials.
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About This Definition
This definition is part of the DrugPrice Drug Pricing Glossary — 34 terms explaining how prescription drug pricing works in the United States. All definitions are written in plain language for patients, caregivers, journalists, and healthcare professionals.