Roundtable: USA - 505(b)(2) Pathway on the Rise: Balancing Litigation Risks Against Market Opportunities

The 505(b)(2) pathway allows pharmaceutical companies to seek regulatory approval for modified or differentiated products while relying in part on existing data linked to branded reference medicines, creating competitive challenges that often fall outside traditional Orange Book assumptions. This roundtable explores how companies are utilising and litigating around 505(b)(2) filings, focusing on how the pathway is being used to navigate existing patent estates and how enforcement strategies are evolving in response.