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Time from orphan drug design to final exclusivity 2018, by current status

This statistic depicts the average number of years from orphan drug designation to last remaining exclusivity as of November 2018, by current exclusivity status. According to the data, drugs that were facing generic/biosimilar competition had an average of 12 years from designation to last remaining exclusivity.

Average time from orphan drug designation to last remaining exclusivity in the U.S. as of 2018, by current status

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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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