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Fact Sheet

What is Hatch-Waxman?

The Drug Price Competition and Patent Term Restoration Act - better known as the Hatch-Waxman Act, is a comprehensive legal framework enacted by Congress in 1984 to streamline the process for generic pharmaceutical approvals and preserve incentives for innovation, including the creation of a procedure for patient litigation involving generic pharmaceuticals. The Hatch-Waxman Act established the legal and economic foundation for today's generic pharmaceutical industry.