# US regulatory exclusivity periods

Source: https://onco.cc/terms/us-regulatory-exclusivity/  
OnCo record `us-regulatory-exclusivity` (Term). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Separate from patents, US law gives an approved drug fixed periods during which the FDA will not approve a copy: five years for a new chemical, three for new clinical studies, seven for an orphan indication, twelve for a biologic, plus six months for paediatric studies.

## Summary

United States, federal statutes read together. Regulatory exclusivity is granted by the FDA under several statutes: five years of new chemical entity exclusivity and three years of new clinical investigation exclusivity under Hatch-Waxman (1984); seven years of orphan exclusivity under the Orphan Drug Act (1983); twelve years for a reference biologic under the BPCIA (2010); six months of paediatric exclusivity added to all of the above under BPCA (2002); and 180 days of generic exclusivity for the first successful patent challenger. Primary text: the FDA's patents and exclusivity FAQ lists each with its statutory citation.

How it works: exclusivity runs from approval and does not depend on having a patent, so it matters most for drugs whose patents are weak or expire early, and for biologics where patents are hard to design around. Patents and exclusivity run in parallel; the later date controls when a generic or biosimilar can launch, which is the logic behind the exclusivity timeline on this site. Orphan exclusivity blocks only the same drug for the same indication, and a company can stack orphan indications to extend protection.

The arguments: the twelve-year biologic term is the longest in the world and the Obama and Trump administrations both proposed cutting it; small-molecule sponsors argue the five-year term is short and that the Inflation Reduction Act's earlier negotiation clock for pills compounds the gap. The European Union's 8+2+1 system and Japan's re-examination period are the comparators.

## Fields

- Kind: Term
- Last checked: 2026-09-17
- Also known as: data exclusivity; market exclusivity; regulatory exclusivity; NCE exclusivity; new chemical entity exclusivity; five-year exclusivity; three-year exclusivity; exclusivity period; exclusivity periods; loss of exclusivity
- Tags: law; us

## Sources

- Wikipedia: https://en.wikipedia.org/wiki/Test_data_exclusivity
- Wikipedia: https://en.wikipedia.org/wiki/Test_data_exclusivity
- FDA: patents and exclusivity, frequently asked questions: https://www.fda.gov/drugs/development-approval-process-drugs/frequently-asked-questions-patents-and-exclusivity

## Connected records

- terms: [Biologics Price Competition and Innovation Act 2010](https://onco.cc/terms/bpcia/), [Biosimilar](https://onco.cc/terms/biosimilar/), [EU data and market protection (8+2+1)](https://onco.cc/terms/eu-data-exclusivity/), [EU pharmaceutical package reform (2023 proposal)](https://onco.cc/terms/eu-pharma-package/), [Hatch-Waxman Act 1984](https://onco.cc/terms/hatch-waxman/), [Inflation Reduction Act 2022: Medicare drug price negotiation](https://onco.cc/terms/inflation-reduction-act/), [Nexavar compulsory licence (India, 2012)](https://onco.cc/terms/nexavar-compulsory-licence/), [Novartis v. Union of India (Glivec, 2013)](https://onco.cc/terms/novartis-glivec-ruling/), [Orphan Drug Act 1983](https://onco.cc/terms/orphan-drug-act/), [Orphan drug designation](https://onco.cc/terms/orphan-designation/), [Paediatric drug laws: BPCA and PREA](https://onco.cc/terms/bpca-prea/), [Supplementary protection certificate (EU)](https://onco.cc/terms/spc/), [TRIPS Agreement and the Doha Declaration](https://onco.cc/terms/trips-doha/)
- bottlenecks: [Incentives reward me-too drugs and marginal gains](https://onco.cc/bottlenecks/b-incentive-misalignment/), [Prices and value](https://onco.cc/bottlenecks/b-drug-pricing/)

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