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The NBER Orange Book Dataset: A user’s guide

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Listed:
  • Durvasula, Maya
  • Hemphill, C. Scott
  • Ouellette, Lisa Larrimore
  • Sampat, Bhaven
  • Williams, Heidi L.

Abstract

This paper introduces a newly digitized, open-access version of the Food and Drug Administration’s “Orange Book”—a linkage between approved small-molecule drugs and the patents that protect them. The Orange Book also reports any applicable regulatory exclusivity that prevents competitive entry. We summarize the Orange Book’s coverage and discuss the opportunities and challenges associated with using these data for research. Empirical validations against various administrative datasets suggest that Orange Book records are, largely, complete and accurate. We conclude with a specific use case—calculating legal exclusivity periods for drugs—to highlight the types of choices that researchers must make when using this resource.

Suggested Citation

  • Durvasula, Maya & Hemphill, C. Scott & Ouellette, Lisa Larrimore & Sampat, Bhaven & Williams, Heidi L., 2023. "The NBER Orange Book Dataset: A user’s guide," Research Policy, Elsevier, vol. 52(7).
    • Handle: RePEc:eee:respol:v:52:y:2023:i:7:s0048733323000756
    DOI: 10.1016/j.respol.2023.104791
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    References listed on IDEAS

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    1. Amy Kapczynski & Chan Park & Bhaven Sampat, 2012. "Polymorphs and Prodrugs and Salts (Oh My!): An Empirical Analysis of “Secondary” Pharmaceutical Patents," PLOS ONE, Public Library of Science, vol. 7(12), pages 1-9, December.
    2. Pierre Azoulay & Joshua S Graff Zivin & Danielle Li & Bhaven N Sampat, 2019. "Public R&D Investments and Private-sector Patenting: Evidence from NIH Funding Rules," The Review of Economic Studies, Review of Economic Studies Ltd, vol. 86(1), pages 117-152.
    3. Lee Branstetter & Chirantan Chatterjee & Matthew J. Higgins, 2016. "Regulation and welfare: evidence from paragraph IV generic entry in the pharmaceutical industry," RAND Journal of Economics, RAND Corporation, vol. 47(4), pages 857-890, November.
    4. Richard C. Levin & Alvin K. Klevorick & Richard R. Nelson & Sidney G. Winter, 1987. "Appropriating the Returns from Industrial Research and Development," Brookings Papers on Economic Activity, Economic Studies Program, The Brookings Institution, vol. 18(3, Specia), pages 783-832.
    5. Hemphill, C. Scott & Sampat, Bhaven N., 2012. "Evergreening, patent challenges, and effective market life in pharmaceuticals," Journal of Health Economics, Elsevier, vol. 31(2), pages 327-339.
    6. Gaétan de Rassenfosse, 2018. "Notice failure revisited: Evidence on the use of virtual patent marking," NBER Working Papers 24288, National Bureau of Economic Research, Inc.
    7. Wesley M. Cohen & Richard R. Nelson & John P. Walsh, 2000. "Protecting Their Intellectual Assets: Appropriability Conditions and Why U.S. Manufacturing Firms Patent (or Not)," NBER Working Papers 7552, National Bureau of Economic Research, Inc.
    8. C. Scott Hemphill & Bhaven N. Sampat, 2011. "When Do Generics Challenge Drug Patents?," Journal of Empirical Legal Studies, John Wiley & Sons, vol. 8(4), pages 613-649, December.
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    Cited by:

    1. Claudia Allende & Juan Pablo Atal & Rodrigo Carril & José Ignacio Cuesta & Andres Gonzalez-Lira, 2023. "Drivers of Public Procurement Prices: Evidence from Pharmaceutical Markets," Working Papers 1413, Barcelona School of Economics.

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    More about this item

    Keywords

    FDA; Orange Book; Drug patents; Intellectual property;
    All these keywords.

    JEL classification:

    • O0 - Economic Development, Innovation, Technological Change, and Growth - - General
    • O3 - Economic Development, Innovation, Technological Change, and Growth - - Innovation; Research and Development; Technological Change; Intellectual Property Rights

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