Knowledge Base

Which drug category has the longest data exclusivity period?

5 January 2024
2 min read

Biologics have the longest data exclusivity period.

Biologic exclusivity conveys 12 years of total market protection. This includes 4 years before an application for a biosimilar (essentially a generic form of a biologic drug product) may be submitted to the FDA and 8 additional years before an application may be approved.

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