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.
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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.
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:
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 eobzip.zip, 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 obzip.zip, depending on your operating system. The file size is about 12 MB.
Save the file to your computer and extract the contents using a program like WinZip or 7-Zip. You will get a folder named ob that contains several PDF files.
Open the PDF files using a program like Adobe Reader or Foxit Reader. Each file corresponds to a different section of the Orange Book, such as Preface, Cumulative Supplement, Patent and Exclusivity Information, etc. You can refer to [the FDA website] for more details on each file.
How to use the Orange Book?
How to search for approved drug products
To search for approved drug products in the Orange Book, you can use either the online database or the data files. Here are some tips on how to use them:
The online database allows you to search by various criteria, such as active ingredient, proprietary name, applicant holder, application number, patent number, exclusivity code, etc. You can also filter by dosage form, route of administration, RLD status, TE code, and approval date range. You can access the online database [here].
The data files allow you to perform your own queries or analyses using your own software or tools. You can use the products.txt file to find basic information on approved drug products, such as active ingredient, trade name, strength, dosage form, route of administration, applicant, application number, approval date, RLD status, and TE code. You can use the patent.txt and exclusivity.txt files to find patent and exclusivity information on approved drug products, such as patent number, expiration date, use code, exclusivity code, expiration date, and type.
How to find patent and exclusivity information
To find patent and exclusivity information in the Orange Book, you can use either the online database or the data files. Here are some tips on how to use them:
The online database allows you to view patent and exclusivity information for each approved drug product by clicking on the application number link. You can also search by patent number or exclusivity code using the advanced search option. You can access the online database [here].
The data files allow you to perform your own queries or analyses using your own software or tools. You can use the patent.txt and exclusivity.txt files to find patent and exclusivity information on approved drug products, such as patent number, expiration date, use code, exclusivity code, expiration date, and type. You can also use the biosub.txt file to find information on biological products that have been deemed biosimilar or interchangeable with a reference product.
Conclusion
The Orange Book is a useful resource for anyone who wants to know more about approved drug products in the United States. It provides information on the safety, effectiveness, and therapeutic equivalence of drugs, as well as patent and exclusivity data. You can download the Orange Book in two formats: as data files or as PDF files. You can also access it online as a searchable database. You can use the Orange Book to find approved generic drugs that can be substituted for brand-name drugs, check the patent and exclusivity status of approved drugs, identify potential generic competitors or opportunities for new drug development, monitor changes or trends in the drug market or regulatory environment, or conduct research or education on drug products or policies.
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FAQs
What is the difference between RLD and RS?What is the difference between RLD and RS?
RLD stands for reference listed drug, which is the innovator drug product that a generic drug must be compared to in bioequivalence studies. RS stands for reference standard, which is the drug product selected by the FDA for conducting bioequivalence studies. The RLD and the RS may or may not be the same product, depending on the availability and suitability of the products. For example, if the RLD is no longer marketed, the FDA may designate another product as the RS.
What is the difference between patent and exclusivity?
Patent and exclusivity are two different types of protection that may apply to an approved drug product. Patent is a legal right granted by the United States Patent and Trademark Office (USPTO) to an inventor or assignee for a limited period of time, usually 20 years from the filing date. Exclusivity is a statutory provision granted by the FDA to an applicant for a limited period of time, usually 3 to 7 years from the approval date. Patent and exclusivity may or may not overlap, depending on the circumstances of each case.
What is the difference between biosimilar and interchangeable?
Biosimilar and interchangeable are two terms that describe the relationship between a biological product and a reference product. A biosimilar is a biological product that is highly similar to a reference product, with no clinically meaningful differences in terms of safety, purity, and potency. An interchangeable is a biosimilar that meets additional standards of interchangeability, such as producing the same clinical result as the reference product in any given patient, and being able to be switched with the reference product without compromising safety or effectiveness.
How often is the Orange Book updated?
The Orange Book is updated monthly by the FDA. The online database reflects the most current information, while the data files and PDF files are updated on the first working day of each month. You can check [the FDA website] for the latest update date and time.
Where can I find more information about the Orange Book?
You can find more information about the Orange Book on [the FDA website], where you can access various resources, such as:
The Orange Book Preface, which explains the scope, organization, content, and use of the Orange Book.
The Orange Book Appendices, which provide additional information on various topics, such as therapeutic equivalence codes, patent use codes, exclusivity codes, etc.
The Orange Book Glossary, which defines key terms used in the Orange Book.
The Orange Book FAQs, which answer common questions about the Orange Book.
The Orange Book Help, which provides guidance on how to use the online database.
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