Dual Dialogue: Preparing for 505(b)(2) Filings - Defending Against “Similar but Different” Entrants

The rise of the 505(b)(2) pathway is changing how branded pharmaceutical and biotech companies approach lifecycle management and litigation. Unlike ANDA generics, 505(b)(2) applicants can enter earlier with differentiated products while relying on branded data, creating a hybrid competitive threat that often falls outside traditional Orange Book assumptions. Join this workshop to hear a discussion around defence strategies from a panel of experts from the generic and innovator industries.

• How in-house teams can identify and defend against 505(b)(2) challenges.
• Distinguish ANDA generics from 505(b)(2) applicants and the implications for defence strategy.
• Identify early warning signs through development activity, regulatory engagement, and competitor monitoring.
• Analyse how formulation, dosing, and delivery changes are used to avoid listed patents.