What Is Hatch Waxman Act?

The Drug Price Competition and Patent Term Restoration Act, informally known as the Hatch-Waxman Act, is a 1984 United States federal law that encourages the manufacture of generic drugs by the pharmaceutical industry and established the modern system of government generic drug regulation in the United States.

How does the Hatch-Waxman Act work?

Broadly speaking, the Hatch-Waxman Act provides incentives for generic drug companies to challenge patents owned by innovators, and it gives generics a research exemption that allows them to develop generic drugs while patents for the brand are still in force — without being liable for infringement.

What is the Hatch-Waxman Act also known as?

The "Drug Price Competition and Patent Term Restoration Act of 1984," also known as the Hatch-Waxman Amendments, established the approval pathway for generic drug products, under which applicants can submit an abbreviated new drug application (ANDA) under section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C ...