This workshop builds on the main-conference content, guiding participants step-by-step through the regulatory and IP interplay in the Hatch-Waxman and BPCIA frameworks. Using live hypotheticals, the leaders will illustrate how exclusivity rules, interchangeability strategy, and litigation timing apply in real-world settings. Recent FDA guidance and court decisions will be examined for their practical and future effects.

Topics of discussion include:

• Deconstructing complex exclusivity disputes and aligning regulatory and IP strategy
• Analyzing FDA and sponsor positions on Orange Book listings, carve-outs, and delisting petitions
• Exploring bioequivalence and interchangeability challenges, including the 2025 removal of routine switching-study requirements
• Addressing complications when sponsors modify products, processes, or quality controls for BLAs, biosimilars, and interchangeable products under 21 C.F.R. § 601.12
• Evaluating litigation and settlement tactics that influence approval and launch windows
• Sequencing lifecycle moves (PTE, PTA, new indications) to preserve exclusivity and payer access
• Building a durable administrative record and coordinating legal and regulatory steps to defend exclusivity