Tag: Hatch-Waxman Act

Paragraph IV certifications let generic drug companies challenge brand-name drug patents before launch, speeding up affordable medicine access. This legal tool under the Hatch-Waxman Act has saved consumers trillions since 1984.

An ANDA is the FDA application that allows generic drugs to enter the market without repeating costly clinical trials. It's how 90% of U.S. prescriptions are filled at a fraction of the cost.