This paper introduces a newly digitized, open-access version of the Food and Drug Administration's "Orange Book"--a linkage between approved small-molecule drugs and the patents that protect them. The Orange Book also reports any applicable regulatory exclusivity that prevents competitive entry....

This article examines the consequences and causes of low enrollment of Black patients in clinical trials. We develop a simple model of similarity-based extrapolation that predicts that evidence is more relevant for decision-making by physicians and patients when it is more representative of the...

In December 2023, the Biden-Harris Administration released a proposed framework for exercising government "march-in" rights on high-priced taxpayer-funded drugs. While both proponents and critics of the new rules view them as having broad scope, march-in rights can be exercised only on patents...

Observers worry that generic patent challenges are on the rise and reduce the effective market life of drugs. A related concern is that challenges disproportionately target high-sales drugs, reducing market life for these “blockbusters.”