U.S. orphan drugs with patents and orphan drug exclusivity as of 2018, by duration

This statistic depicts the number of orphan drugs in the U.S. that were protected by patents or other distinctions as of 2018, by duration of patents or orphan drug exclusivity. According to the data, among those drugs that were still protected by ODE (orphan drug exclusivity) and patent exclusivity, 156 had patents that were longer than their orphan drug exclusivity.

Number of orphan drugs with patent protection and orphan drug exclusivity in the U.S. as of 2018, by duration

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Release date

December 2018


United States

Survey time period

as of November 2018

Number of respondents

503 respondents

Special properties

drugs with any approved orphan designation

Supplementary notes

ODE = orphan drug exclusivity.
Patent protection includes other forms of market exclusivity (e.g., pediatric extension, 505(b)(2)). Comparison of latest patent and earliest orphan exclusivity dates as the determination of longer duration.

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Statistics on "Orphan drugs"

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