Drug Price Competition and Patent Term Restoration Act of 1984 Law and Legal Definition
Drug Price Competition and Patent Term Restoration Act of 1984 is a United States federal statute signed into law by President Reagan on September 24, 1984. It established the modern system of generic drugs. The Act amends the Federal Food, Drug, and Cosmetic Act. It sets forth the process by which would-be marketers of generic drugs can file Abbreviated New Drug Applications (ANDAs) to seek Food and Drug Administration approval of the generic. The Act further provides 180 day exclusivity to companies that are the "first-to-file" an ANDA against holders of patents for branded counterparts.
The Act is popularly known as Hatch-Waxman Act, after its sponsors, Henry Waxman of California and Senator Orrin Hatch of Utah.
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