The Hatch-Waxman Act regulates competition between brand-name and generic drugs in the United States. We examine a feature of the Act that has attracted great controversy but little systematic attention. “Paragraph IV” challenges are a mechanism for generic drug makers to challenge the...

“Reverse” or “exclusion” payments to settle pharmaceutical patent lawsuits are facilitated because the Hatch-Waxman Act has been interpreted to give 180 days of generic exclusivity to the first generic company to file for FDA approval, whether or not that company succeeds in invalidating...