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Number of orphan designations accepted in the U.S. 2003-2020

This statistic displays the number of accepted orphan designations per year in the United States from 2003 to the first half year of 2020. In 2019, there were 339 orphan designations accepted. Orphan drugs are used to target rare diseases or disorders, which in the United States is defined as less than 200,000 patients. The development of orphan drugs are currently incentivized in the United States through the Orphan Drug Act of 1983.

Annual number of accepted orphan designations in the United States from 2003 to 2020

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Sources

Release date

October 2020

Region

United States

Survey time period

2003 to 2020

Supplementary notes

* Added from the FDA's website on orphan drug designations.

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Statistics on "Orphan drugs"

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