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  5. Approved Drug Products with Therapeutic Equivalence Evaluations | Orange Book
  1. Drug Approvals and Databases

Approved Drug Products with Therapeutic Equivalence Evaluations | Orange Book


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.

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Orange Book Publications, Supplements, and Appendices

Orange Book Patent & Exclusivity Information

  • Orange Book Patent Listing Dispute List (PDF - 829 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

Related Guidance and References

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.

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