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
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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:
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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.
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:
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Laura and John Arnold Foundation (000004624)
Scope of Project
Subject Terms:
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Pharmaceuticals;
Patent and Exclusivities;
FDA;
Drug;
Patent
Time Period(s):
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1/1/2005 – 12/31/2015
Data Type(s):
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administrative records data
Methodology
Data Source:
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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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