Orange Book patent and exclusivity data - 1985-2016
July 17, 2018
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
The data was digitized by Professor Heidi Williams.
We recommend starting by reading README.pdf for a general description of and
documentation describing the construction of these data files.
Contents and Directory Structure
/1_orange_book_PDFs/ contains the full FDA Orange Books,
obtained via a FOIA request, for years 1980- 2016 (Patent and Exclusivity tables begin in 1985).
This folder also contains excerpts of the PDFs that were sent to a data entry firm for hand-entry.
Also within this directory is documentation of the FOIA request.
To download this entire folder as a zipped file click on 1_orange_book_PDFs.zip.
/2_hand_entered_by_firm_excel/ contains the raw Excel files as entered by the data entry firm.
To download this entire folder as a zipped file click on 2_hand_entered_by_firm_excel.zip.
/3_cross_check_sources/ contains the Stata files and PDFs that
were used for cross-checking the data entry firm’s output.
To download this entire folder as a zipped file click on 3_cross_check_sources.zip.
/4_clean_exclusivity_tables_stata/ contains the clean data files
as well as code and other intermediate files used in creating the clean files, including the following:
- – The subfolder /scripts/ contains the .do file that creates the clean data sets and the .log file.
- – The subfolder /corrected_discrepancies_excel/ contains hand-entered corrections made during
data construction. These files should not be deleted or altered in any way.
– There are three subfolders – /temp/, /txt/, and /exported_discrepancies_excel/ that are created when
the .do file is run. These subfolders can safely be removed after the .do file completes.
– Running the file create_final_data.do creates the clean Stata files. The code was written for Stata 15
running on a Linux operating system.
– Each of the files contains data for all Orange Books 1985-2016 (excluding 1986, for which there is no
Orange Book). If you want exclusivity data only for a particular edition, simply open the data file and
keep only that year.
To download this entire folder as a zipped file click on 4_clean_tables_stata.zip.
Page last modified June 27, 2019