Listed, Stayed, Delayed: Brand-Name Drug Manufacturer’s Strategic Patent Listings and the Breakdown of the Hatch-Waxman Act
[1] I. Background on the Orange Book A. Origin and Role of the Orange Book On October 31, 1980, the FDA’s released its first edition of the Approved Drug Products with Therapeutic Equivalence Evaluations (playfully named the “Orange Book”), which identifies drugs that are approved based on safety and effectiveness. [2] This database is monitored by the FDA and provides a list of patents and the market exclusivities that protect brand-name drugs. [3] The Orange Book plays a central role...
