Identifying Extensions of Protection in Prescription Drugs: Navigating the Data Landscape for Large-Scale Analysis

Principal Investigator(s):  View help for Principal Investigator(s) Robin Feldman, The University of California, Hastings College of the Law

Version:  View help for Version V2

Name File Type Size Last Modified
Identifying-Extensions-of-Protection-in-Prescription-Drugs--Orange-Book-Project-Methodology-.pdf application/pdf 358.1 KB 12/17/2018 02:35:PM
Orange-Book-Appendices.pdf application/pdf 171.3 KB 12/07/2018 11:36:AM
Orange_Book.csv text/csv 1.5 MB 12/07/2018 07:33:AM
Orange_Book_Data_Dictionary.xlsx application/vnd.openxmlformats-officedocument.spreadsheetml.sheet 11.4 KB 12/07/2018 07:34:AM

Project Citation: 

Feldman, Robin. Identifying Extensions of Protection in Prescription Drugs: Navigating the Data Landscape for Large-Scale Analysis. Ann Arbor, MI: Inter-university Consortium for Political and Social Research [distributor], 2018-12-19. https://doi.org/10.3886/E104781V2

Project Description

Summary:  View help for Summary Patents and exclusivities have become an increasingly important component in the “life cycle management” strategies that are employed by pharmaceutical companies to prolong the period of market monopoly for their drugs.

Presenting the first comprehensive study of evergreening, this study examines all pharmaceuticals in the U.S. the market between 2005 and 2015, collecting 160,000 data points to note every instance in which a company added a new patent or exclusivity. This study gathers patent and exclusivity information published in the “Orange Book,” which is a regular FDA publication containing information on approved drugs, their therapeutically equivalent generics, and the patents and exclusivities attached to approved drugs, among other drug-related data.
Funding Sources:  View help for Funding Sources Laura and John Arnold Foundation (000004624)

Scope of Project

Subject Terms:  View help for Subject Terms Pharmaceuticals; Patent and Exclusivities; FDA; Drug; Patent
Time Period(s):  View help for Time Period(s) 1/1/2005 – 12/31/2015
Data Type(s):  View help for Data Type(s) administrative records data

Methodology

Data Source:  View help for Data Source This study gathers patent and exclusivity information published in the "Approved Drug Products with Therapeutic Equivalence Evaluations" or “Orange Book” (https://www.accessdata.fda.gov/scripts/cder/ob/), which is a regular FDA publication containing information on approved drugs, their therapeutically equivalent generics, and the patents and exclusivities attached to approved drugs, among other drug-related data.

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Published Versions

V2 [2018-12-19]

V1 [2018-12-17]

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