There’s an App for That: FDA Launches Orange Book Express App

November 11, 2015

On November 9, 2015, FDA launched the Orange Book Express application, which provides a list of the drug products approved by the FDA.

What is the Orange Book?

The Drug Price Competition and Patent Term Restoration Act of 1984, commonly known as the Hatch-Waxman Act, was passed to encourage and simplify the development of generic products for pharmaceutical companies. The Act required FDA to publish a list of Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book).

The Orange Book first appeared as a print publication in October 1980 and provided information about innovator and generic drug product approvals. On October 31, 1997,FDA added the Orange Book Search to its website. Since 2005, the Electronic Orange Book (EOB) has been updated on a daily basis with a current list of approved generic products.

Today, that list includes:

  • All drug products approved by FDA on the basis of safety and efficacy
    • Drugs approved only on the basis of safety are not included in the book
  • Therapeutic equivalence evaluations for approved generic drugs
  • Patent and exclusivity information that may be associated with drug products

The Orange Book is one of the most popular pages on FDA’s website; it is also one of the most commonly searched terms.

Orange Book Express Mobile Application

The recently released mobile app is compatible with both Apple® and Android TM devices. It provides users with access to timely information about innovator and generic drugs and provides an easy and convenient way to obtain the Orange Book’s information. The app is very user friendly and lets users search by active ingredient, proprietary name, applicant holder, application number, and patent number.

Search results are organized into tabs which show product records from the Prescription Drug Product List, the Over-the-Counter Drug Product List, and the Discontinued Drug Product List from the Orange Book. Additionally, all product entries contain the same links to patent and exclusivity information that is listed in the electronic and paper versions of the Orange Book.

The main difference between the two versions (app vs. online) is the app’s inability to filter results and search for text within the results. However, the app includes a link to the Orange Book website enabling users to have direct access to all of the information that is available from the current website version.

For more information, visit the FDA’s website.


August 22, 2019

Only 12% of Generic Drugs Reviewed Were Approved in the 1st Review Cycle, says GAO Report

On August 7th, the U.S. Government Accountability Office (GAO) published its report on generic drug applications. In the report, GAO comments on the number of products approved on the first review...

July 25, 2016

FDA Revises Review Timeline Due to Increasing Number of Orphan Drug Applications

FDA Revises Review Timeline Due to Increasing Number of Orphan Drug Applications: In 1983 Congress passed the Orphan Drug Act, which created FDA’s Orphan Drug Designation (ODD) program. The goal of...

November 12, 2018

FDA Approves New Opioid Despite Controversy

On Friday, November 2nd, FDA announced its approval of Dsuvia™, a highly potent synthetic opioid manufactured by AcelRx Pharmaceuticals, Inc. The drug is a sublingual (under the tongue) formulation...