Number of orphan designations accepted in the U.S. 2003-2023
This statistic displays the number of accepted orphan designations per year in the United States from 2003 to 2023. In 2017, there were 477 orphan designations accepted, a record number so far. 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.
