Legal Definitions - Hatch–Waxman Act

The Hatch–Waxman Act is a federal law that was passed in 1984. It provides incentives for the development of generic drugs and 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.

For example, if a drug company spends a lot of money developing a new drug and gets a patent for it, they have a certain amount of time to sell that drug exclusively before other companies can make generic versions. However, the FDA has to approve the drug before it can be sold. This can take a long time, and the drug company may lose some of the time they have to sell the drug exclusively. The Hatch–Waxman Act allows the drug company to regain that lost time on their patent.

The Act also provides incentives for other companies to develop generic versions of drugs. This helps to make drugs more affordable for people who need them.