Volume 42, Issue 1 (FAll 2023)
By Robin Feldman*
Abstract. In 1984, with the passing of the Hatch-Waxman Act, Congress orchestrated a compromise that permanently changed how drug markets operate. This piece of legislation created an expedited pathway for generics to enter the market, and, in exchange, brand drugs could extend their patents to account for time lost during their market approval process. Although this well-configured trade was supposed to help generics enter the scene quicker, the current drug market landscape makes one question whether this legislation has succeeded in its aims. The following study explores the lifecycle of top-selling brand drugs in comparison to the vision put forth by the Hatch-Waxman Act. Using the legislation as a framework, the article examines the data of 236 top-selling drugs, quantifying the average length of patent terms and their extensions, as well as any additional market monopoly time secured thereafter.