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NBER Orange Book Dataset


contributors: Prof. Heidi Williams, Maya Durvasula, C. Scott Hemphill, Lisa Larrimore Ouellette, Bhaven N. Sampat

tags: drugs, pharmaceuticals, us, exclusivity

related projects:


timeframe: 1985-2016

description: Each edition of the Orange Book provides a snapshot of unexpired patent protection at a moment in time. As patents on a drug expire and new patents are issued, these changes are reflected in later editions. The Orange Book also provides a snapshot of unexpired regulatory exclusivity granted by the FDA. For example, certain novel drugs receive five years of regulatory exclusivity that blocks the entry of generic competition, even in the absence of any patents. Combining multiple editions reveals a comprehensive picture of patent and regulatory protection as it evolves over a drug’s lifecycle. These data files provide digital versions of the US Food and Drug Administration (FDA)'s Orange Book patent and exclusivity tables for years 1985-2016 (no Orange Book was published in 1986). PDF versions of the Orange Books were obtained via a Freedom of Information Act (FOIA) request, and data from these PDF files was either hand-entered or parsed in order to create the digital files.

last edit: Mon, 19 Jun 2023 16:46:55 GMT