What the Orange Book Reveals About Trends in Patent Density, Evergreening, and Exclusivity

26 June 2020
Dr. Omar Robles

In “What the Orange Book Reveals About Trends in Patent Density, Evergreening, and Exclusivity,” Senior Consultant Dr. Omar Robles, Boston Univeristy JD Candidate Emily Rothkin, and NERA Senior Analyst Daniel Yu compile annual snapshots of the Orange Book made available by the FDA from 2011 through 2018. The authors found salient trends from the data, focusing on assessing the density of patents listed for NDA-approved drug products and the average period of exclusivity that listed patents statutorily provide.