Lifecycle & Exclusivity Strategy

Regulatory exclusivities, label scope, and follow-on competition shape product value across the lifecycle. Many of these questions are FDA regulatory strategy questions before they become disputes. We help sponsors and investors identify and secure exclusivities, preserve lifecycle opportunities, and assess follow-on competition and competitor regulatory positioning.

We advise on:

• Exclusivity strategy in development and at approval, including new chemical entity, new clinical investigation, orphan drug, pediatric, GAIN Act/QIDP, and biologics reference product exclusivities
• Label scope and indication strategy at approval, including how label language affects the reach of exclusivity, the room for follow-on carve-outs, and the long-term value of the asset
• 505(b)(2) and biosimilar pathway analysis, including how reference-product exclusivities, labeling, and FDA approval precedents affect what a follow-on application can rely on and where additional support may be required
• Lifecycle planning around label expansions, supplemental applications, and indication-specific exclusivities

Selected Experience

• Advised sponsor on the quantum of evidence required for a supplemental indication in a rare disease.
• Helped sponsor obtain approval for a line extension for an orphan drug product, overcoming the potential need for additional clinical trials.
• Evaluated key clinical assets for regulatory exclusivity eligibility, including novel NCE exclusivity questions.
• Advised 505(b)(2) sponsor on choice of RLD strategy and impact on approval timelines.
• Helped defend client against competitor objections to a grant of orphan drug exclusivity.