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Research Letter
September 2016

Generic Drug Approvals Since the 1984 Hatch-Waxman Act

Author Affiliations
  • 1Yale University School of Medicine, New Haven, Connecticut
  • 2Program on Regulation, Therapeutics, and Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts
  • 3Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts
  • 4Center for Outcomes Research and Evaluation, Yale–New Haven Hospital, New Haven, Connecticut
  • 5Departments of Medicine and the History of Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland
  • 6Section of General Internal Medicine and the Robert Wood Johnson Foundation Clinical Scholars Program, Department of Medicine, Yale University School of Medicine, New Haven, Connecticut
  • 7Department of Health Policy and Management, Yale University School of Public Health, New Haven, Connecticut
JAMA Intern Med. 2016;176(9):1391-1393. doi:10.1001/jamainternmed.2016.3411

The Hatch-Waxman Act of 1984 catalyzed the generic drug market, which now constitutes over 85% of US prescriptions.1 The number of generic alternatives to a brand-name drug affects prices; availability of at least 4 generic drugs has been associated with brand-name price reductions of approximately 60% when compared with fewer or no generics.24 Recently, prices for several generic drugs have increased 100-fold or more, in part because of limited competition.5 We characterized the number of generic versions for all brand-name drugs approved by the US Food and Drug Administration (FDA), along with associations between the number of generics and characteristics of brand-name drugs.

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