> ## Documentation Index
> Fetch the complete documentation index at: https://docs.rhizomeai.com/llms.txt
> Use this file to discover all available pages before exploring further.

# FDA Orphan Drug Designations

> Search filters and result fields of fda_orphan_drugs.

* **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.

## Filters

Send these under `filters.fda_orphan_drugs` in a [search](/api-reference/v3/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.

<ParamField body="cf_grid_key" type="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).
</ParamField>

<ParamField body="generic_name" type="string">
  BM25 keyword match on the generic / active-ingredient name (e.g. "fidaxomicin", "certepetide"). Use trade\_name for marketed brand.
</ParamField>

<ParamField body="trade_name" type="string">
  BM25 keyword match on the marketed brand name (e.g. "Dificid"). NULL on designations whose drugs are not yet marketed.
</ParamField>

<ParamField body="sponsor" type="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.
</ParamField>

<ParamField body="indication" type="string">
  BM25 keyword match on the orphan-designation indication text — the disease/condition for which the designation was granted (e.g. "Osteosarcoma", "Cystic Fibrosis").
</ParamField>

<ParamField body="approved_indication" type="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.
</ParamField>

<ParamField body="designation_status" type="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`.
</ParamField>

<ParamField body="fda_approval_status" type="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`.
</ParamField>

<ParamField body="sponsor_country" type="string">
  Exact sponsor country name (e.g. "United States", "Japan", "Switzerland", "China").
</ParamField>

<ParamField body="designation_date_from" type="string (date)">
  Inclusive lower bound on the orphan designation date (YYYY-MM-DD).
</ParamField>

<ParamField body="designation_date_to" type="string (date)">
  Inclusive upper bound on the orphan designation date.
</ParamField>

<ParamField body="marketing_approval_date_from" type="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.
</ParamField>

<ParamField body="marketing_approval_date_to" type="string (date)">
  Inclusive upper bound on the FDA marketing-approval date.
</ParamField>

## 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`


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