Publisher:
National Bureau of Economic Research, Cambridge, Mass
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...
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ZBW - Leibniz-Informationszentrum Wirtschaft, Standort Kiel
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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
Publisher:
National Bureau of Economic Research, Cambridge, Mass
Recent policy attention has focused on proposals to reduce prices for drugs that have received public funding. From an implementation perspective, such policies rely on public disclosure of government support for research. In this paper, we...
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ZBW - Leibniz-Informationszentrum Wirtschaft, Standort Kiel
Inter-library loan:
No inter-library loan
Recent policy attention has focused on proposals to reduce prices for drugs that have received public funding. From an implementation perspective, such policies rely on public disclosure of government support for research. In this paper, we highlight two conceptual problems with past attempts to measure these public disclosures, and construct a new data set which corrects for these problems. Our corrected measures suggest that under-reporting of public research support is less of an issue than previously thought