Drug Price Competition and Patent Term Restoration Act (1984)

The Drug Price Competition and Patent Term Restoration Act, also known as the Hatch-Waxman Act, passed in 1984 in the United States. It was named after Representative Henry Waxman of California and Senator Orrin Hatch of Utah. They are credited for the introduction of this law in the United States. The Hatch-Waxman Act had two major objectives: availability of cost-effective generic drugs to the general public and promotion of the discovery of new drugs by protecting the rights of the innovator drug manufacturers by giving them patent term restoration and exclusivities.

Prior to the Hatch-Waxman Act, the generic drug approval process was a lengthy and costly affair for generic drug companies. A generic drug has similar dosage form, strength, route of administration, quality, performance characteristics, and ...