FDA Orange Book Express 2.0

FDA Orange Book Express 2.0

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.




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