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Open Access
Peer-reviewed
Research Article
Patents and regulatory exclusivities on FDA-approved insulin products: A longitudinal database study, 1986–2019
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Anders Olsen,
Roles Conceptualization, Data curation, Investigation, Methodology, Writing – original draft, Writing – review & editing
Affiliations Program On Regulation, Therapeutics, And Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School, Boston, Massachusetts, United States of America, Department of Medicine, Beth Israel Deaconess Medical Center and Harvard Medical School, Boston, Massachusetts, United States of America
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Reed F. Beall,
Roles Conceptualization, Investigation, Methodology, Writing – review & editing
Affiliations Program On Regulation, Therapeutics, And Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School, Boston, Massachusetts, United States of America, Department of Community Health Sciences, Cumming School of Medicine, University of Calgary, Calgary, Canada
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Ryan P. Knox,
Roles Investigation, Methodology, Writing – review & editing
Affiliations Program On Regulation, Therapeutics, And Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School, Boston, Massachusetts, United States of America, Harvard-MIT Center for Regulatory Science, Boston, Massachusetts, United States of America
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Sean S. Tu,
Roles Conceptualization, Investigation, Methodology, Supervision, Writing – review & editing
Affiliation West Virginia University College of Law, Morgantown, West Virginia, United States of America
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Aaron S. Kesselheim,
Roles Conceptualization, Funding acquisition, Investigation, Methodology, Supervision, Writing – review & editing
Affiliation Program On Regulation, Therapeutics, And Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School, Boston, Massachusetts, United States of America
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William B. Feldman
Roles Conceptualization, Data curation, Investigation, Methodology, Project administration, Supervision, Writing – original draft, Writing – review & editing
* E-mail: wbfeldman@bwh.harvard.edu
Affiliations Program On Regulation, Therapeutics, And Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School, Boston, Massachusetts, United States of America, Division of Pulmonary and Critical Care Medicine, Department of Medicine, Brigham and Women’s Hospital and Harvard Medical School, Boston, Massachusetts, United States of America
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Patents and regulatory exclusivities on FDA-approved insulin products: A longitudinal database study, 1986–2019
- Anders Olsen,
- Reed F. Beall,
- Ryan P. Knox,
- Sean S. Tu,
- Aaron S. Kesselheim,
- William B. Feldman
- Published: November 16, 2023
- https://doi.org/10.1371/journal.pmed.1004309