Working Paper: NBER ID: w30628
Authors: Maya Durvasula; C. Scott Hemphill; Lisa Larrimore Ouellette; Bhaven N. Sampat; Heidi L. Williams
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: Orange Book; patent protection; pharmaceuticals; regulatory exclusivity; generic drugs
JEL Codes: O00; O03
Edges that are evidenced by causal inference methods are in orange, and the rest are in light blue.
| Cause | Effect |
|---|---|
| presence of patents listed in the Orange Book (O34) | reduced likelihood of generic entry (L15) |
| completeness of patent listings (O34) | enhanced ability to track legal exclusivity periods (O34) |
| enhanced ability to track legal exclusivity periods (O34) | affects market competition (L13) |
| completeness of the dataset (C55) | better assessments of the impacts of public funding on innovation (O38) |
| public funding (I22) | more robust patent protections and exclusivity periods (O34) |