Navigating Orange Book Listings

The Drug Price Competition and Patent Term Restoration Act of 1984–also known as the Hatch-Waxman Act–amended patent law and drug law to facilitate pharmaceutical development and encourage greater access to generic medicines. Under Hatch-Waxman, the Food and Drug Administration requires new drug applications to be accompanied by certain patent information, which the FDA then lists in its Approved Drug Products with Therapeutic Equivalence Evaluations publication, also known as the Orange Book. This can be a complicated process with significant consequences for improper listings. In this podcast, Finnegan attorneys Shana Cyr, David Weingarten and Ashley Winkler discuss what pharmaceutical companies should know about the complex Orange Book listing process.