Hatch-Waxman Act 1984

United States, federal statute. The Drug Price Competition and Patent Term Restoration Act, known by its sponsors' names as Hatch-Waxman, was signed on 24 September 1984 (Public Law 98-417). It amended section 505 of the Federal Food, Drug, and Cosmetic Act and Title 35 of the patent code. Primary text: the FDA's ANDA and exclusivity pages link the statute and regulations.

What it changed: a generic manufacturer files an abbreviated new drug application (ANDA) showing bioequivalence to the brand instead of repeating clinical trials; the brand lists its patents in the Orange Book and gets up to five years of patent term restored for time lost in development and review, capped at fourteen years of protection after approval, plus five years of new chemical entity data exclusivity and three years for new clinical studies. A generic that certifies the brand's patents are invalid or not infringed (a Paragraph IV certification) triggers litigation and an automatic 30-month stay of approval; the first successful challenger earns 180 days of generic exclusivity. The Bolar exemption lets generics do development work during the patent term.

What it means for cancer care: it is why imatinib, capecitabine, abiraterone, bortezomib and lenalidomide now cost a fraction of their launch prices in the United States, and it drives the exclusivity timeline on this site. The arguments concern 'pay for delay' settlements (curbed by the Supreme Court's Actavis decision in 2013), patent thickets and product hopping that stretch protection, and the fact that biologics fell outside it until the 2010 biosimilar law.