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

This statistic depicts the number of orphan drugs in the U.S. that were protected by patents or other distinctions as of 2018. According to the data, 205 drug were still protected by orphan drug exclusivity and patent exclusivity.

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

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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)). The 101 therapies no longer protected by either ODE or patent exclusivity did not have generic competitors as of June 2018. The 116 therapies no longer protected by either ODE or patent exclusivity currently have one or more generic or biosimilar competitors in the market.

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Statistics on "Orphan drugs"

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