Easy Access to the Latest Drug Approvals and Patent Expirations

The Food and Drug Administration (FDA) Orange Book is now in its 39th edition. The information in the book stems from the requirement of the FDA to provide states information regarding pharmaceutical therapeutic equivalence. States were creating formularies and looking for options to keep costs down yet ensure equivalence. Over time the physical then online and now app version of the Orange Book called Orange Book Express was created. 

Today the book contains information on new drug approvals, new patent applications/approvals/discontinuations, etc. The book is updated monthly. The newest version is available for both iOS and Android and has improved search security. Examples of useful information one can quickly access from the app based on the June update includes newly added patents for the inhaled insulin, afrezza, and patent discontinuation for the blockbuster erectile dysfunction drug from Lilly, Cialis. The app divides information into convenient sections such as “Newly Added Patents,” “Patent Delistings,” and web-based information. The app’s overall search function allows the user to search by active ingredient, applicant holder, application number, patent number, etc. 

Evidence-based medicine

  • The app contains all of the FDA information regarding new drug approvals, patent discontinuations, patent exclusivity.

Who would benefit from this app

  • Students, residents, primary care providers, pharmacists, and patients interested in FDA information regarding new drug approvals, patent expirations, etc.


  • The app is free.


  • Multiple ways to look up information.
  • Details on patent information.
  • Monthly updates and price.


  • Some information requires an internet connection to retrieve.
  • Directions could be more clear.
  • Search function can be confusing at first.


  • The FDA Orange Book Express 2.0 is a handy free guide to information on new drug patents, discontinued drug patents, and other patent exclusivity information. The app is easy to use and permits search by active ingredient, proprietary name, applicant holder, etc. The app is likely most useful to pharmacists or other providers and even patients interested in this type of drug information. 

Overall Score

o 4.0 stars

User Interface

o 4.0 stars

Self-explanatory, but directions included with multiple search options.

Multimedia Usage

o 4.0 stars

Easy-to-use search function with multiple options as well as hyperlinks to FDA Orange book websites. 


o 5.0 stars

App is free.

Real-World Applicability

o 3.5 stars

Likely not an app you would utilize frequently, but occasionally would be worth referencing.

Device Used For Review

o iPhone 8S running iOS 12.4.     

Available for Download for iPhone, iPad, and Android.

Disclaimer: The views expressed are those of the author(s) and do not reflect the official policy of the Department of the Army, the Department of Defense or the U.S. Government.