Hatch-Waxman Act (1984)
Congress passed the Drug Price Competition and Patent Term Restoration Act, known as Hatch-Waxman. It let generic makers file abbreviated applications referencing brand drugs, created the Orange Book patent list, and gave drugmakers incentives to challenge weak patents.
Generic drugs grew from a small share of prescriptions into the dominant form of dispensing over the following decades.
The law remains the backbone of US generic competition and the very mechanism patent thickets now exploit.
Hatch-Waxman built the framework the JAMA study measures: the same Orange Book listing that enabled generic entry now catalogs the secondary-patent thickets delaying it.
