FDA Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book)

FDA Orange Book | Orange Book | Approved Drug Products with Therapeutic Equivalence Evaluations | Electronic Orange Book | Overview of the Orange Book 

Drugs@FDA Orange Book

What Is the Orange Book?

The orange book contains a list of generic drugs approved by US FDA. The orange book provides access to information, such as brand-name products, products patents and exclusivity, related to all the generic products approved by FDA. The Orange Book also known as publication Approved Drug Products with Therapeutic Equivalence Evaluations identifies drug products approved on the basis of safety and effectiveness by the FDA under the Federal Food, Drug, and Cosmetic Act (the Act) and related patent and exclusivity information.  

The Orange Book lists drugs which are not only approved as safe; they must also be effective for human use. Drugs whose efficacy or safety approval has been withdrawn are excluded from the FDA Orange Book. A drug that is currently subject to regulatory action can appear in the Orange Book. The Orange Book is available online for free in electronic format (Electronic Orange Book). It is mostly updated on a daily basis.  

What are the Uses of Orange Book? Parts of Orange Book  

·    Medical professionals can easily search for generic equivalents to brand-name drugs, drug patents, and drug exclusivity

·      Orange Book can also be accessed online by Consumers

·      Both doctors and patients can search approved uses for drugs and patent expiration dates for name-brand drugs.

Parts of Orange Book Search Results in the Orange Book

The Orange Book is Composed of Four Parts:   

1)    Approved prescription drug products with therapeutic equivalence (TE) evaluations  

2)    Approved over-the-counter (OTC) drug products

3)    Drug products approved by Center for Biologics Evaluation and Research

4)   Drug products that have never been marketed, are for other used such as exportation, military use, or have been discontinued from marketing   

Search Results in the Orange Book 

·         Active Ingredient

·         Brand/Proprietary Name

·         Dosage Type

·         Route of Administration of the drugs

·         Drug Product Strength

·         Applicant Name

·         Application Number

·         Approval Date

·         TE Code

·         Marketing Status

Some of the Terminology used in Orange Book 

Therapeutic Equivalents

Approved drug products are considered to be therapeutic equivalents if they are pharmaceutical equivalents (PE) for which bioequivalence has been demonstrated.

These products are expected to have the same clinical effect and safety profile when administered to patients under the conditions specified in the labeling.

Pharmaceutical Equivalents

Pharmaceutical equivalents are drug products that are in identical dosage forms, route(s) of administration and contain identical amounts of the identical active drug ingredient, i.e., the same salt or ester of the same therapeutic moiety. 

Reference Listed Drug

A reference listed drug (RLD) is identified by FDA as the drug product upon which a marketing authorization applicant relies in seeking approval of its drug product (ANDA).

FDA’s generally designate a drug product as RLD if that that product has been approved for safety and effectiveness under section 505(c) of the FD&C Act.

Reference Standard

A reference standard (RS) is the drug product approved by FDA that a marketing authorization applicant seeking approval of a drug product (ANDA) must use in conducting a bioequivalence study in human. 

FDA generally selects the reference listed drug as the reference standard. 

In case where the reference listed drug has been withdrawn from market but not for the safety or effectiveness, FDA can select an ANDA drug product as the reference standard provided that is therapeutically equivalent to the reference listed drug. 

Key Takeaways

The FDA Orange Book is a freely accessible and available as a PDF, in print, and electronically. It contains a list maintained by the FDA describing all pharmaceutical drugs that have been proven both safe and effective.

The Orange Book is useful for finding generic drug equivalents, which are often less costly treatment to patients.