Forfeiture Analysis of 180-Day Paragraph IV Exclusivity: Industry Perspective
Tuesday, November 3, 2026
1:30 p.m. - 2:45 p.m.
This session will examine industry considerations related to forfeiture determinations for 180-day Paragraph IV exclusivity. Panelists will discuss when a first filer may retain exclusivity, including scenarios involving tentative approval timing, and how subsequent filers may benefit from earlier clarity regarding exclusivity status. The session will provide industry’s perspectives on practical challenges, regulatory interpretation, and opportunities to improve predictability in exclusivity-related decision-making.
Jessica Greenbaum, JD
Director, Regulatory Affairs Policy U.S., Sandoz Inc.
Omar Jabri, LLM
Vice President, Global Lead and IP Strategies, Apotex Inc.
Brian McCormick, JD, MHS
Vice President and Chief Regulatory Counsel, Teva Pharmaceuticals
Panelist:
Scott Tomsky, MS
Global Head of Regulatory Affairs, Biocon Biologics
Chad Landmon, JD
Shareholder and Chair of the Hatch-Waxman and Biologics Practice, Polsinelli
