Viewing the Orange Book Under a Microscope: The Regulatory Framework & its Implications for Branded Drug Makers

To access a recording of this webinar or receive a copy of the slides, please contact [email protected].

Congress passed the Hatch-Waxman Act to establish a framework that encourages innovation by branded drug makers, but shortens the time to market for generic drug makers. A critical aspect of that framework is the Food and Drug Administration (FDA)’s Orange Book. The Orange Book provides a listing of approved drug products and their related patent and regulatory exclusivities, which is at the center of all Hatch-Waxman litigation disputes.

On Thursday, April 14, please join Fish attorneys Kelly Del Dotto and Megan Chacon for “Viewing the Orange Book Under a Microscope: The Regulatory Framework & its Implications for Branded Drug Makers.” Our speakers will discuss in detail the importance of the Orange Book in Hatch-Waxman litigation, as well as its purpose and value within the legal industry.

• How the Orange Book Fits into the Hatch-Waxman Framework
• Orange Book Listable Patents and Litigation Strategy
• Summary of the Changes in the January 2021 “Orange Book Act”
• What’s Next: FDA’s Review of What Patents can be Listed in the Orange Book