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  • Dataset id: fda_orphan_drugs
  • Jurisdiction: US · FDA
  • Date field: date_designated. The search’s top-level date_from and date_to filter on it.
  • Access: any API key.

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Filters

Send these under filters.fda_orphan_drugs in a search request. A filter not listed here, or a value of the wrong type, is a 400. The top-level date_from and date_to set designation_date_from and designation_date_to below, so give a date in one place only.
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string
Exact match on the source’s internal designation key, a 6-digit integer string (e.g. “961823”, “548216”). Use when the user pastes a bare CF Grid Key. Multiple rows can share a cf_grid_key when one designation carries multiple FDA approval events (label extensions).
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string
BM25 keyword match on the generic / active-ingredient name (e.g. “fidaxomicin”, “certepetide”). Use trade_name for marketed brand.
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string
BM25 keyword match on the marketed brand name (e.g. “Dificid”). NULL on designations whose drugs are not yet marketed.
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string
BM25 keyword match on the sponsor company name. Prefer the company root over the legal suffix (“Inc”, “Ltd”, “Pharmaceuticals”) since BM25 tokenizes either way.
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string
BM25 keyword match on the orphan-designation indication text — the disease/condition for which the designation was granted (e.g. “Osteosarcoma”, “Cystic Fibrosis”).
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string
BM25 keyword match on the FDA-approved labeled indication. Only populated when fda_approval_status reflects an approval (designation_status = “Designated/Approved”); empty matches will not surface designations FDA has not yet approved for the orphan use.
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string
Exact orphan-designation status. “Designated” = active designation, not yet FDA-approved for the orphan use; “Designated/Approved” = FDA approved the product for the orphan use; “Designated/Designation Withdrawn or Revoked” = designation was withdrawn by the sponsor or revoked by FDA before approval; “Designated/Approved/Designation Withdrawn or Revoked” = an approved designation that was later withdrawn or revoked (~17 cases).Values: Designated, Designated/Approved, Designated/Designation Withdrawn or Revoked, Designated/Approved/Designation Withdrawn or Revoked.
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string
Exact match on whether the designation has received FDA marketing approval for the orphan use. “FDA Approved for Orphan Indication” selects approved designations (designation_status contains “Approved”); “Not FDA Approved for Orphan Indication” selects the rest. Never NULL.Values: FDA Approved for Orphan Indication, Not FDA Approved for Orphan Indication.
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string
Exact sponsor country name (e.g. “United States”, “Japan”, “Switzerland”, “China”).
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string (date)
Inclusive lower bound on the orphan designation date (YYYY-MM-DD).
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string (date)
Inclusive upper bound on the orphan designation date.
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string (date)
Inclusive lower bound on the FDA marketing-approval date. Rows with NULL marketing_approval_date (no approval yet) are excluded by this filter.
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string (date)
Inclusive upper bound on the FDA marketing-approval date.

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Fields

Each result from this dataset has these in fields: approved_labeled_indication, cf_grid_key, date_designated, date_withdrawn_or_revoked, designation_status, exclusivity_end_date, exclusivity_protected_indication, fda_approval_status, generic_name, id, marketing_approval_date, orphan_indication, sponsor_city, sponsor_company, sponsor_country, sponsor_state, trade_name, url