Hatch Waxman > Summary

The Drug Price Competition and Patent Term Restoration Act (Public Law 98-417), informally known as the Hatch-Waxman Act, is a 1984 United States federal law which encourages the manufacture of generic drugs by the pharmaceutical industry and established the modern system of government generic drug regulation in the United States. Representative Henry Waxman of California and Senator Orrin Hatch of Utah sponsored the act. Hatch-Waxman amended the Federal Food, Drug, and Cosmetic Act. Section 505(j) of the Act, codified as 21 U.S.C. § 355(j), outlines the process for pharmaceutical manufacturers to file an Abbreviated New Drug Application (ANDA) for approval of a generic drug by the Food and Drug Administration (FDA). Section 505(j)(2)(A)(vii)(IV), often referred to as Paragraph IV, gives the first company to file an ANDA for a particular drug 180 days of exclusive rights to market the drug as the generic alternative to the branded drug. The 180 days begins on the first day of marketing the drug under the ANDA, if the paragraph IV certification is not challenged by the pioneer manufacturer. If the paragraph IV certification is challenged by the pioneer manufacturer, the 180 days begins on the date a court finds that,as required under paragraph IV, the patent of the pioneer manufacturer was not valid, enforceable, or not infringed.