written on 04.03.2014

30 Years of the US Generic Industry under Hatch-Waxman


In 1984 the generic industry reached a turning point. This was the year that the Drug Price Competition and Patent Term Restoration Act or “Hatch-Waxman Act” was introduced, simplifying the process for generic drug manufacturers to enter the market. Critically, the bill stipulated that generic drugs would no longer be required by the FDA to […]