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Reader task: understand what the FDA Orange Book lists, decode its equivalence codes and reference-drug terms, and pick the right way to search or download it. Facts below come from the FDA pages listed under Sources, checked 2026-11-07.
What the Orange Book is and who runs it
The Orange Book is the common name for Approved Drug Products with Therapeutic Equivalence Evaluations, a publication of the U.S. Food and Drug Administration (FDA). According to FDA’s Orange Book page, it lists FDA-approved drug products together with patent and exclusivity information, and it identifies drug products approved on the basis of safety and effectiveness. In pharmacy, “the orange book” means this FDA publication. Per the Orange Book Preface, the main criterion for inclusion is that the drug was approved under the Federal Food, Drug, and Cosmetic Act and that approval has not been withdrawn for safety or effectiveness reasons.
What is the primary purpose of the Orange Book?
Its stated purpose is public information. The Preface says the therapeutic equivalence (TE) evaluations serve as public information and advice to state health agencies, prescribers and pharmacists. For technology transfer and licensing staff it has a second role: it is where patent and exclusivity information for approved products is published, which makes it a reference point when a licensed compound’s protection is reviewed (see how long patents last).
How to read therapeutic equivalence codes
The TE code is the part of an entry most readers need decoded. Per the Preface:
| Code | What the Preface says |
|---|---|
| A | Products FDA considers therapeutically equivalent to other pharmaceutically equivalent products. |
| B | Products FDA considers not to be therapeutically equivalent to other pharmaceutically equivalent products at this time. |
| AB | Multisource products are generally coded AB if data and information are submitted demonstrating bioequivalence. |
The code is an FDA evaluation published as advice to prescribers, pharmacists and state agencies.
RLD and reference standard: related but not identical
The Reference Listed Drug (RLD) is, in the Preface’s words, the drug product upon which an applicant relies in seeking approval of its ANDA. The reference standard is the product an applicant must use in conducting an in vivo bioequivalence study. The reference standard is usually the RLD, but not always, so the two terms are not synonyms. FDA also links a “Reference Listed Drugs by ANDA Reference Standard List” from its Orange Book page. For the application route that depends on the RLD, see our guide to the FDA ANDA application and the NDA, BLA, 505(b)(2) and ANDA comparison.
What is not in the Orange Book
- Drug products with tentative approvals are not included.
- Distributors and repackagers are not identified.
Patent listings and disputes
The Orange Book carries patent information, and FDA’s page states that, under 21 CFR 314.53(f)(1), a person can dispute the accuracy or relevance of patent information published in the Orange Book. FDA keeps a cumulative Patent Listing Dispute List and links lists of patent use codes and exclusivity codes from the same page. The statutory background is the 1984 Hatch-Waxman Act, summarised in our ANDA guide; for the licensing side see patent licensing.
Orange Book search, PDF and download options
Per FDA’s page, the Orange Book can be searched by active ingredient, proprietary name, applicant, application number, dosage form, route and patent number. The downloadable data files are updated monthly.
| Format | What FDA offers |
|---|---|
| Online search | Search by the fields listed above. |
| Annual Edition and Current Cumulative Supplement; Appendices A to C. | |
| Data files | Compressed .zip data files, with instructions for loading them into a spreadsheet. |
| openFDA API | An openFDA Orange Book API returning JSON. |
FDA’s page gives a contact address for reporting data errors.
Common mistakes
- Reading a B code as a safety warning. The Preface defines it as not considered therapeutically equivalent at this time.
- Assuming the RLD is always the bioequivalence reference standard.
- Looking for tentatively approved products, distributors or repackagers, which the book does not list.
Related pages
| Topic | Where to go |
|---|---|
| Generic approval route | FDA ANDA application |
| Pathways compared | NDA vs BLA vs 505(b)(2) vs ANDA |
| Patent term | How long patents last |
| Licensing | Patent licensing |
FAQ
What is the Orange book about?
It is FDA’s list of approved drug products with therapeutic equivalence evaluations, plus patent and exclusivity information.
What is an orange book in pharmacy?
The FDA publication whose TE codes tell prescribers and pharmacists which approved products FDA considers therapeutically equivalent.
What is the primary purpose of the Orange Book?
Public information and advice on therapeutic equivalence for state health agencies, prescribers and pharmacists.
What are orange book liberals?
That phrase is unrelated to the FDA publication.
Is there an Orange Book PDF or download?
Yes: PDF editions, zip data files and an openFDA API, as in the table above.
Sources
- FDA, Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book), checked 2026-11-07.
- FDA, Orange Book Preface, checked 2026-11-07.
