Regulatory Exclusivity

Key facts

Granted by

FDA, at approval, when statutory requirements are met

Where listed

Orange Book (drugs) and Purple Book (biologics)

Longest standard period

12 years of reference product exclusivity for biologics

Different from

Patents, which the U.S. Patent and Trademark Office issues

What is regulatory exclusivity?

Exclusivity is a reward written into federal drug law for bringing certain products or evidence to market. It attaches to an approval rather than an invention, so it can protect a drug that has no patents, and it can outlast or expire before the patents that also cover the drug.

Exclusivity works by restricting the FDA itself. Depending on the type, the agency may be barred from accepting competing applications, from approving them, or from approving them only for a protected use.

Main types of exclusivity

The most common U.S. exclusivities are:

• New chemical entity (NCE): 5 years for a drug with no previously approved active moiety; ANDA and 505(b)(2) applications generally cannot be submitted during that time, or during the first 4 years with a Paragraph IV certification.
• New clinical investigation: 3 years for changes such as a new indication or dosage form that required new clinical studies essential to approval; it blocks approval of competitors for that change.
• Orphan drug exclusivity: 7 years for a drug approved for a designated rare disease or condition.
• Pediatric exclusivity: 6 months added to existing exclusivities and, for drugs, listed patents, when a sponsor completes pediatric studies the FDA requested.
• Generic exclusivity: 180 days for the first Paragraph IV ANDA filer, and 180 days for certain competitive generic therapies.
• Biologics: 12 years of reference product exclusivity, plus exclusivity for the first interchangeable product.
• GAIN exclusivity: 5 years added to other exclusivities for qualifying antibacterial and antifungal drugs.

Why exclusivity matters

Loss of exclusivity forecasts must combine exclusivities and patents. A drug with long patents but short exclusivity can face Paragraph IV challenges early, while a drug whose patents have lapsed may still be shielded by an unexpired exclusivity. Orange Book exclusivity dates can change with pediatric extensions and new approvals.

The scope of orphan exclusivity has been contested. In Catalyst Pharmaceuticals v. Becerra (2021), a federal appeals court read it to cover the whole disease, and the FDA said in 2023 that it would keep tying orphan exclusivity to the approved uses or indications in other matters.