Orange Book

Key facts

Official title

Approved Drug Products with Therapeutic Equivalence Evaluations

Maintained by

FDA Center for Drug Evaluation and Research

First published

1980

Legal basis

Section 505(j)(7) of the FD&C Act

Scope

Products approved under NDAs and ANDAs; BLA biologics are excluded

What is the Orange Book?

The Orange Book is the FDA's authoritative list of drug products approved on the basis of safety and effectiveness under the Federal Food, Drug, and Cosmetic Act. It takes its nickname from the orange cover of its first print edition in 1980, and today it is used mainly as an online search and downloadable data files.

The Hatch-Waxman Act of 1984 made it the hub of generic drug competition. Brand companies submit patent information for their New Drug Applications (NDAs), and generic applicants must address each listed patent when they file an Abbreviated New Drug Application (ANDA).

What the Orange Book contains

Each product record ties together several kinds of data:

• Product details: active ingredient, dosage form, route, strength, trade name, applicant, application number and approval date.
• Marketing status: prescription, over-the-counter or discontinued.
• Therapeutic equivalence (TE) codes such as AB, plus flags for the Reference Listed Drug (RLD) and reference standard.
• Patents: drug substance, drug product and method-of-use patents, with expiration dates and use codes.
• Exclusivities: codes and expiration dates for protections such as new chemical entity, orphan drug and pediatric exclusivity.

Why the Orange Book matters

The Orange Book is the starting point for estimating when a brand drug can face generic competition. The latest listed patent or exclusivity expiry gives a first approximation of loss of exclusivity, although litigation, settlements, pediatric extensions and unlisted patents can move the real date in either direction.

Pharmacists and payers use TE codes to identify substitutable generics, and pricing analysts use them to group products that actually compete at the pharmacy counter.

Limitations of Orange Book data

The FDA does not check whether a listed patent actually claims the drug. Its role in patent listing is ministerial, and disputes go to the courts. The Federal Trade Commission has challenged some device-related patent listings since 2023. Process and packaging patents are not eligible for listing, and biologics licensed under BLAs appear in the Purple Book instead.