This workshop provides a practical overview of Canada’s drug approval, patent, and market access processes. Participants will explore regulatory approvals, HTA evaluations, pricing, reimbursement, and patent/exclusivity timelines. Using a hypothetical case study, the session highlights real-world implications for patient access and market strategy, equipping participants with tools to navigate these pathways effectively.

Hypothetical Case Study Discussion: Drug X Patent Lapse in Canada
In 2025, Acme Drug Company’s patent for Drug X expired earlier than expected due to a missed maintenance fee, resulting in loss of exclusivity three years ahead of schedule. Participants will analyze the impact on market access, pricing, generic entry, and patient availability, and discuss lessons for lifecycle planning and strategic decision-making.

• Navigating Canada’s drug approval process and regulatory requirements
• Analyzing how HTA, pricing, and reimbursement decisions affect patient access
• Understanding the influence of patent and exclusivity timelines on market entry
• Applying insights from the semaglutide case to inform strategic planning
• Identifying strategies to align lifecycle management with regulatory and market access goals