In 2025, there were *** orphan designations accepted. Orphan drugs are used to target rare diseases or disorders, which in the United States are defined as less than ** patients. The development of orphan drugs is currently incentivized in the United States through the Orphan Drug Act of 1983.
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Food and Drug Administration. (March 17, 2026). Annual number of accepted orphan designations in the United States from 2003 to 2025 [Graph]. In ÌÇÐÄÆƽâ°æ. Retrieved July 23, 2026, from /statistics/373412/number-orphan-designations-accepted-in-the-us/
Food and Drug Administration. "Annual number of accepted orphan designations in the United States from 2003 to 2025." Chart. March 17, 2026. ÌÇÐÄÆƽâ°æ. Accessed July 23, 2026. /statistics/373412/number-orphan-designations-accepted-in-the-us/
Food and Drug Administration. (2026). Annual number of accepted orphan designations in the United States from 2003 to 2025. ÌÇÐÄÆƽâ°æ. ÌÇÐÄÆƽâ°æ Inc.. Accessed: July 23, 2026. /statistics/373412/number-orphan-designations-accepted-in-the-us/
Food and Drug Administration. "Annual Number of Accepted Orphan Designations in The United States from 2003 to 2025." ÌÇÐÄÆƽâ°æ, ÌÇÐÄÆƽâ°æ Inc., 17 Mar 2026, /statistics/373412/number-orphan-designations-accepted-in-the-us/
Food and Drug Administration, Annual number of accepted orphan designations in the United States from 2003 to 2025 ÌÇÐÄÆƽâ°æ, /statistics/373412/number-orphan-designations-accepted-in-the-us/ (last visited July 23, 2026)
Annual number of accepted orphan designations in the United States from 2003 to 2025 [Graph], Food and Drug Administration, March 17, 2026. [Online]. Available: /statistics/373412/number-orphan-designations-accepted-in-the-us/
