Hatch-Waxman Act Fundamentals

This practice note provides an overview of the approval process for prescription drugs under the Drug Price Competition and Patent Term Restoration Act of 1984, commonly called the Hatch-Waxman Act. It also explains the scheme for patent litigation between brand-name drug companies and generic drug companies under the Act. The Hatch-Waxman Act generally covers chemically manufactured drugs only. The counterpart statute covering biologic drugs, the Biologics Price Competition and Innovation Act of 2009, is not addressed in this practice note.