OB Express 2.0

FDA Orange Book Express

*** Important note: We regret to inform you our mobile app will no longer be available as of 10/03/2024. In its place, we are excited to offer you a responsive web design option via the Orange Book.

The Orange Book website provides a seamless experience, including access to all our features and services, online and on your mobile devices. You may access the site in its entirety at the following location: https://www.accessdata.fda.gov/scripts/cder/ob/index.cfm. ***

We appreciate your understanding and support during this transition.

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New in this version:

• Search results and drug listings now clarify which listed drugs are reference listed drugs (RLDs) and which are reference standards.
• The application now uses HTTPS encryption to provide a secure connection.

With FDA’s Orange Book Express app, it’s now faster and easier to find information about:

• Drug products approved on the basis of safety and effectiveness by the Food and Drug Administration (FDA)
• Information about patents and exclusivity

Orange Book Express allows you to:

• Search by Active Ingredient or Proprietary Name; Applicant Holder (Firm); Application Number; or Patent Number.
• Search all marketing statuses (Rx, OTC, Discontinued) with one search.
• Look up patent and exclusivity information.
• Identify Reference Listed Drugs (RLDs) and determine if a drug product has a therapeutic equivalent.
• Browse Patent Delistings and Newly Added Patents.