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    Orphan Drug Designation

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    Orphan drug designation:
    wikipedia.org+3
    • Refers to a status designated by the FDA.
    • Gives companies researching cures for rare diseases a seven-year window of exclusive marketing rights post-approval.
    • Provides reductions in certain application fees and tax incentives.
    • Is granted if the drug is being investigated for a rare disease or condition.
    • The drug must treat a condition affecting fewer than 200,000 persons in the United States or not be profitable within 7 years following FDA approval.
    4 Sources
    Orphan drug - Wikipedia
    In the U.S., orphan drug designation means that the sponsor qualifies for certain benefits, but it does not mean the drug is safe, effective or legal.
    Wikipedia
    https://en.wikipedia.org/wiki/Orphan_drug
    Orphan Drug Status: What it Means, How it Works, Example - Investopedia
    Orphan drug status, a status designated by the Food and Drug Administration (FDA), gives companies researching cures for rare diseases a seven-year window of exclusive marketing ri…
    Investopedia
    https://www.investopedia.com/ask/answers/06/orphandrugstatus.asp
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    The Orphan Drug Act: Legal Overview and Policy Considerations - CRS Reports
    Orphan-drug designations are granted by the FDA if the drug is currently being or will be investigated for a rare disease or condition and the approval or licensure of the drug wou…
    Congress.gov
    https://crsreports.congress.gov/product/pdf/IF/IF12605
    1 Orphan Drugs - U.S. Food and Drug Administration
    Orphan Drug Definition An orphan drug is defined in the 1984 amendments of the U.S. Orphan Drug Act (ODA) as a drug intended to treat a condition affecting fewer than 200,000 perso…
    Food and Drug Administration (.gov)
    https://www.fda.gov/media/83372/download
    wikipedia.org
    investopedia.com
    congress.gov
    fda.gov