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 files.

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.