Strategic Approaches to Loss of Exclusivity: A Commercial Playbook

The impending wave of Loss of Exclusivity (LOE) presents significant challenges for pharmaceutical companies. With more than 20 high-revenue biologics and numerous smaller products set to lose exclusivity in the coming years, organizations must implement a structured approach to navigate this transition effectively.

While LOE is often perceived as the conclusion of a product’s lifecycle, it represents a critical opportunity to extend value, optimize resources, and sustain patient access. A well-defined, proactive commercial strategy is essential to mitigating risks and capitalizing on potential opportunities.

Herspiegel’s Playbook for Navigating Loss of Exclusivity Through Commercial Levers provides pharmaceutical leaders with a comprehensive framework to address LOE strategically.

Our playbook examines:

• Optimal timing for LOE planning based on the product’s characteristics and the therapeutic area to ensure seamless market transition
• Strategies to mitigate revenue impact while maintaining patient access
• Key commercial levers to enhance late-stage product value
• Best practices for cross-functional alignment and stakeholder coordination

Failure to establish a strategic LOE plan can result in operational inefficiencies, revenue erosion, and lost market opportunities. This playbook outlines essential steps to effectively manage LOE, ensuring that legacy products continue to deliver value within a broader portfolio strategy.

LOE strategy execution doesn’t begin at the moment of exclusivity loss. It starts years in advance. Early preparation is essential to ensure organizational readiness and proactively navigate this market shift.

Download our playbook to read our strategic approach to position your company for success and ensure a smooth transition.