fda-orphan-drugs

is a Data Source.

The FDA Orphan Drug Designations and Approvals database, maintained by the FDA Office of Orphan Products Development (OOPD), lists drugs and biological products that have received orphan designation under the Orphan Drug Act for rare diseases or conditions, from 1983 to the present. Each record gives the generic and trade names, designation date, designated indication, designation status (including withdrawal or revocation dates), FDA orphan approval status, approved labeled indication, marketing approval date, orphan exclusivity end date and protected indication, and sponsor name and address. Indications are free-text and are not coded to a disease vocabulary. The full listing held 8,247 records when exported on 2026-10-04.

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External IDs

Infores: infores:fda-orphan-drug-db

Product Summary

Contacts

FDA Office of Orphan Products Development

URL: https://www.fda.gov/about-fda/office-chief-medical-officer/office-orphan-products-development

Products

From this Resource

ID	Name	URL	Category	Format	Description
fda-orphan-drugs.search	Orphan Drug Designations and Approvals Search	oopd	Graphical Interface	http	Web search form for the orphan drug d...
fda-orphan-drugs.export	Orphan Drug Designations Spreadsheet Export	oopd	Product	http	Spreadsheet export of search results ...
fda-orphan-drugs.docs ⚠	Designating an Orphan Product Documentation	designating-orphan-product-drugs-and-biological-products	Documentation	http	FDA guidance page on orphan designati...

From other Resources

ID	Name	URL	Category	Format	Relation	Description
mychem.api	MyChem.info API	query	Programming Interface	json	had primary source	MyChem.info REST API (v1) for queryin...

Details

FDA Orphan Drug Designations and Approvals

The FDA Office of Orphan Products Development (OOPD) maintains a searchable database of every drug and biological product granted orphan designation since the Orphan Drug Act of 1983. Records cover the designated indication, designation and approval status, marketing approval and orphan exclusivity dates, and the sponsor. The full listing can be exported as a spreadsheet from the search form, though only through a form submission rather than a fixed download URL. The data is a U.S. Government work in the public domain. openFDA does not expose an orphan designation endpoint.