The NBER Orange Book Dataset: A user’s guide

Maya Durvasula, C. Scott Hemphill, Lisa Ouellette, Bhaven Sampat and Heidi Williams ()

Research Policy, 2023, vol. 52, issue 7

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.

Keywords: FDA; Orange Book; Drug patents; Intellectual property (search for similar items in EconPapers)
Date: 2023
References: View references in EconPapers View complete reference list from CitEc
Citations: View citations in EconPapers (3)

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Working Paper: The NBER Orange Book Dataset: A User’s Guide (2022)
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Persistent link: https://EconPapers.repec.org/RePEc:eee:respol:v:52:y:2023:i:7:s0048733323000756

DOI: 10.1016/j.respol.2023.104791

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