Orange Book- 5 Basic Interesting facts

This article contains information about It Contains 6 Basic Interesting facts on Orange Book.

What is mean by Orange Book ?

It is publications published by the FDA called as “Approved Drug Products with Therapeutic Equivalence Evaluations,” but commonly it is called as orange book. It provides information about drug products, that have been approved by the FDA based on their safety and effectiveness.

The first print publication arise on October 1980 and the publication printed book cover is  orange-colored.

Orange Book Consists of Four Parts :

This book composed of four parts as below :

1. Approved prescription drug products with therapeutic equivalence evaluations
2. Approved over-the-counter (OTC) drug products for those drugs that may not be marketed without NDAs or ANDAs because they are not covered under existing OTC monographs.
3. Drug products administered by the Center for Biologics Evaluation and Research.
4. Discontinued Drug Products.

For what purpose orange book is used ?

1. Provides information about drugs approved by the FDA based on safety and effectiveness.
2. Helps healthcare professionals identify approved drugs and determine if generic drugs are equivalent to brand-name drugs.
3. Provides information about drug patents and exclusivity periods for drug manufacturers.
4. Allows consumers to find information about the drugs they are taking, including active ingredients and dosage forms.
5. Helps to provide information to healthcare professionals, drug manufacturers, and consumers.

Orange book is available Electronically and on Mobile APP too.

Orange Book has been available electronically from 2005. It is very easy to search electronically by entering options like  proprietary name, active ingredient , dosage form, route of administration, or application number and company/Applicant Name. The app is available on Apple and Android devices and offers a mobile resource for generic drug , patent and exclusivity information.

In orange book, Application number starts with “N” for New Drug Applications (NDA) and application number starts with “A” For Abbreviated New drug applications (ANDA).

What is mean by Therapeutically equivalent ?

Approved Drug products considered to be therapeutic equivalents if they are pharmaceutical equivalent for which bioequivalence has been demonstrated and They are expected to produce same clinical effect and safety profile in patients as specified in the labeling with respect to Innovator Drugs /RLD.

Therapeutically equivalent Codes starting with “A” means drugs are Therapeutically Equivalent and Starting with ” B ” denotes they are not therapeutically not equivalent.

What is mean by Pharmaceutical Equivalent?

Drug products considered as pharmaceutical Equivalent if Drug products is of identical dosage forms and route(s) of administration and it contain identical amounts of the identical active drug ingredient, i.e., the same salt or ester of the same therapeutic moiety with respect to innovator Drugs /RLD.

Frequently asked Questions (FAQs) :

Why is it called the Orange Book?

This Book is named after the orange cover of the printed publication. It is also available online and electronically, but the physical book has an orange cover.

What is the purpose of the Orange Book?

This book is a valuable resource for healthcare professionals, regulators, and the pharmaceutical industry. It helps determine whether a generic drug is equivalent to a brand-name (reference) drug in terms of safety and efficacy.

What information does the Orange Book contain for each drug product?

It provides information on active ingredients, dosage forms, routes of administration, and approved indications for each drug product. It also includes patent and exclusivity information.

How can healthcare professionals use the Orange Book?

Healthcare professionals refer to this book to make informed decisions about substituting generic drugs for brand-name drugs. They can ensure that generic drugs are therapeutically equivalent and suitable for a patient’s treatment

Can the Orange Book be used to identify available generics for a brand-name drug?

Yes, healthcare professionals and consumers can use this book to identify generic alternatives to brand-name drugs and assess their therapeutic equivalence.

What is the relationship between the Orange Book and patent information?

The Orange Book includes patent and exclusivity information, which is important for understanding when a generic version of a brand-name drug can be marketed. Patents and exclusivity periods can affect generic drug competition.