Approved Drug Products with Therapeutic Equivalence Evaluations | Orange Book

Background

The publication Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book) identifies drug products approved on the basis of safety and effectiveness by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (the Act) and related patent and exclusivity information. For more information on the Orange Book including its history, see the Orange Book Preface.

Search the Orange Book Database

Search approved drug products by active ingredient, proprietary name, applicant, application number, dosage form, route of administration or patent number.

Jump to:

• Orange Book Publications, Supplements, and Appendices
• Orange Book Patent & Exclusivity Information
• Additional Orange Book Resources
• Related Guidance and References
• Contact Us

Orange Book Publications, Supplements, and Appendices

• Orange Book Annual Edition (PDF - 10 MB)
• Orange Book Preface
• Orange Book Current Cumulative Supplement (PDF - 2.4 MB)
• Appendix A: Product Name Index (PDF - 177 KB)
• Appendix B: Product Name Sorted by Applicant (PDF - 482 KB)
• Appendix C: Uniform Terms (PDF - 125 KB)

Orange Book Patent & Exclusivity Information

• Orange Book Patent Listing Dispute List (PDF - 262 KB)
  Section 314.53(f)(1) outlines a process through which a person can dispute the accuracy or relevance of patent information published in the Orange Book, as well as the process for the relevant new drug application (NDA) holder to respond to such disputes. For all patent listing disputes, FDA promptly posts information on (1) whether a patent listing dispute has been submitted to FDA and (2) whether the NDA holder has timely responded to the patent listing dispute. The Patent Listing Dispute List contains relevant drug product information and the disputed patent. The list is cumulative in nature and is organized by drug product established name and patent number(s).
• List of Patent Use Codes and Definitions
• List of Exclusivity Codes and Definitions – includes lists of codes with numbers and codes without numbers.
• Frequently Asked Questions on Patents and Exclusivity

Additional Orange Book Resources

• Frequently Asked Questions on The Orange Book
• Orange Book Data Files (compressed .zip file)
  For additional information, such as descriptions of data fields in the Orange Book Search, please see Orange Book Data Files.
• Additions/Deletions for Prescription and OTC Drug Product Lists
• Reference Listed Drugs by ANDA Reference Standard List (PDF - 115 KB)
• Pre-Hatch-Waxman Abbreviated New Drug Applications (PANDA) in the Orange Book (PDF - 1.76MB)

Related Guidance and References

• Guidance for Industry:
  • Orange Book Questions and Answers (July 2022)
  • Evaluation of Therapeutic Equivalence (July 2022)
  • Referencing Approved Drug Products in ANDA Submissions (October 2020)
  • Marketing Status Notifications Under Section 506I of the Federal Food, Drug, and Cosmetic Act (August 2020)
• Reference standard data updates to the Orange Book (January 2017)
• Biologics Price Competition and Innovation Act (BPCIA) of 2009:
  • BPCIA Orange Book Transition Edition (PDF - 9.6 MB)
  • “Deemed to be a License” Provision of the BPCI Act (April 2020)

Contact Us

The Orange Book downloadable data files are updated monthly. We make every effort to prevent errors and discrepancies in the Approved Drug Products data files; however, if you wish to report an error or discrepancy in drug data, please send a brief description of the problem to orangebook@fda.hhs.gov.

General questions related to the drug data in these files should be directed to the Center for Drug Evaluation and Research, Division of Drug Information druginfo@fda.hhs.gov.

Requests for more specific information should be submitted in writing or directed to the FDA's Freedom of Information (FOIA) Staff.