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The NBER Orange Book Dataset: A User's Guide / Maya Durvasula, C. Scott Hemphill, Lisa Larrimore Ouellette, Bhaven N. Sampat, Heidi L. Williams.
- Format:
- Book
- Author/Creator:
- Durvasula, Maya.
- Series:
- Working Paper Series (National Bureau of Economic Research) no. w30628.
- NBER working paper series no. w30628
- Language:
- English
- Physical Description:
- 1 online resource: illustrations (black and white);
- Place of Publication:
- Cambridge, Mass. National Bureau of Economic Research 2022.
- Summary:
- 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.
- Notes:
- Print version record
- November 2022.
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