Perspectives on Enquiry & Evidence

Cytel's blog featuring the latest industry insights.

Understanding Market Exclusivity for Orphan Drug Products

Market exclusivity for orphan drugs is a regulatory mechanism designed to incentivize pharmaceutical companies to develop treatments for rare diseases. This exclusivity grants the drug manufacturer a specific period during which no similar medicinal products can be approved for the same therapeutic indication, irrespective of patent status. This period provides a critical market advantage, allowing the company to recover the costs of research, development, and marketing without competitive products.

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