Hatch-Waxman Act Law & Legal Definition


Hatch-Waxman Act is the popular name of Drug Price Competition and Patent Term Restoration Act of 1984 a U.S. federal law that provides incentives for the development of generic drugs. It allows drug-patent owners to regain the time lost on a patent's term while awaiting approval of the drug from the Food and Drug Administration. The Act is named after its sponsors, Henry Waxman of California and Senator Orrin Hatch of Utah. This Act has been described as the one of the most important pieces of legislation affecting the drug industry.