• Leadership and Structure
• Corporate Governance
• Public Policy
  • Access and Affordability
  • Pricing and Value
    • Drug Spending and Utilization
    • Research and Development
    • Clinical Trials
    • Intellectual Property
    • Price Controls
    • Importation
    • Generics
      • Generic Competition
      • Hatch-Waxman Act
  • Health Care Reform
  • Resources
  • Pat the Pill
• History
• Accolades

Generics: Learn More About the Hatch-Waxman Act

In 1984 Congress passed the Drug Price Competition and Patent Term Restoration Act, more commonly known as the Hatch-Waxman Act, in an effort to accelerate generic drugs to market and provide patent time restoration to innovator companies while their medicines were under review by the FDA. The Act has created a successful generic drug industry, which now accounts for over half of all prescriptions dispensed in the U.S.

• Fact Sheet: Pharmaceutical Patent Incentives - The Pharmaceutical Research and Manufacturers Association (PhRMA)
  This fact sheet, compiled by the Pharmaceutical Research and Manufacturers Association (PhRMA), provides an overview of the Hatch-Waxman Act and other pharmaceutical patent incentives.
  • View the Fact Sheet
• Congressional Budget Office Report - How Increased Competition from Generic Drugs has Affected Prices and Returns in the Pharmaceutical Industry - CBO, July 1998
  This Congressional Budget Office (CBO) study examines the extent to which competition from generic drugs has increased since the Hatch-Waxman Act was passed in 1984. It also analyzes how that competition has affected the returns from developing a drug.
  • Read the Study
• Federal Trade Commission Study - Generic Drug Entry Prior to Patient Expiration - FTC, July 2002
  The recommendations in this report by the Federal Trade Commission (FTC) suggest changes to the Hatch-Waxman Amendments. The report states that "beyond any doubt, Hatch-Waxman has increased generic drug entry," but goes on to say that "two of the provisions governing generic drug approval (the 180-day exclusivity and the 30-month stay provisions) are susceptible to strategies that, in some cases, may have prevented the availability of more generic drugs... [and] ... have the potential for abuse."
  • Download the Report

Last Updated September 2007