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Gabriel Sanchez
Gabriel Sanchez

Download Orange Book Express: A Mobile App for Drug Information

How to Download the Orange Book

The Orange Book is a valuable resource for anyone who wants to know more about approved drug products in the United States. It contains information on the safety, effectiveness, and therapeutic equivalence of drugs, as well as patent and exclusivity data. In this article, you will learn what the Orange Book is, why you should download it, how to download it, and how to use it.

What is the Orange Book?

Definition and purpose of the Orange Book

The Orange Book is the common name for the publication Approved Drug Products with Therapeutic Equivalence Evaluations, which is issued by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act. The Orange Book identifies drug products that have been approved by the FDA on the basis of safety and effectiveness, and also provides information on their therapeutic equivalence. Therapeutic equivalence means that a generic drug can be substituted for an innovator drug with the same clinical effect and safety profile.

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Types of information in the Orange Book

The Orange Book contains various types of information on approved drug products, such as:

  • The active ingredient, dosage form, route of administration, trade name, applicant, strength, application number, and approval date of each product.

  • The therapeutic equivalence code, which indicates whether a generic drug is equivalent to an innovator drug.

  • The reference listed drug (RLD), which is the innovator drug product that a generic drug must be compared to in bioequivalence studies.

  • The reference standard (RS), which is the drug product selected by the FDA for conducting bioequivalence studies.

  • The patent number, expiration date, and use code of each patent related to an approved drug product.

  • The exclusivity code, expiration date, and type of each exclusivity granted to an approved drug product.

Why download the Orange Book?

Benefits of having the Orange Book data files

The Orange Book is available online in two formats: as a searchable database and as downloadable data files. The downloadable data files are updated monthly and contain all the information in the online database. The benefits of having the Orange Book data files are:

  • You can access them offline without an internet connection.

  • You can manipulate them using your own software or tools.

  • You can perform custom queries or analyses on them.

  • You can integrate them with other data sources or applications.

Uses of the Orange Book data files

The Orange Book data files can be used for various purposes, such as:

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  • Finding approved generic drugs that can be substituted for brand-name drugs.

  • Checking the patent and exclusivity status of approved drugs.

  • Identifying potential generic competitors or opportunities for new drug development.

  • Monitoring changes or trends in the drug market or regulatory environment.

  • Conducting research or education on drug products or policies.

How to download the Orange Book?

Steps to download the Orange Book data files

To download the Orange Book data files, follow these steps:

  • Go to [the FDA website](^1^) and click on Orange Book Data Files (compressed).

  • Select either eobzip.exe or, depending on your operating system. The file size is about 4 MB.

  • Save the file to your computer Extract the contents of the file using a program like WinZip or 7-Zip. You will get a folder named eob that contains several text files.

  • Open the text files using a program like Excel or Notepad. Each file has a different name and format, but they all have a header row that explains the fields and values. You can refer to [the FDA website] for more details on each file.

Steps to download the Orange Book PDF files

If you prefer to download the Orange Book as PDF files, follow these steps:

  • Go to [the FDA website] and click on Orange Book PDF Files (compressed).

Select either obzip.exe or o


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