Why is new drug product exclusivity also known as the Hatch/Waxman exclusivity?
On September 24, 1984 the President signed into law the Drug Price Competition and Patent Term Restoration Act of 1984 (Hatch/Waxman Amendments). Title 1 of the Hatch/Waxman Amendments amended the Federal Food, Drug, and Cosmetic Act (the Act) to expand the universe of drugs for which FDA would accept ANDAs. The Hatch/Waxman Amendments also provided for New Drug Product Exclusivity and are often referred to as Hatch/Waxman exclusivity since Senator Hatch and Congressman Waxman sponsored the amendments in Congress to encourage research and development, as well as to speed entry of generic drugs into the market.
