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Assyro AI

Search FDA Orange Book

Search and read FDA Orange Book records through the Assyro API: approved drug products, therapeutic equivalence codes, patents and exclusivities.

GEThttps://api.assyro.com/v1/sources/orange-book/search

Preview: api.assyro.com is not serving production data yet. This page follows the API's published description and may change before launch.

Search and read FDA Orange Book records from your own code: approved drug products, therapeutic equivalence codes, patents and exclusivities. Published by U.S. Food and Drug Administration (www.accessdata.fda.gov/scripts/cder/ob/index.cfm); answered from Assyro's copy, refreshed daily 12:00 UTC.

Licence: public domain (see the terms). Each record links to its page at the source.

Example: "Which Eliquis products have listed patents?"

Search

GET https://api.assyro.com/v1/sources/orange-book/search with any of these query parameters. Repeat a parameter for a list (?phase=PHASE2&phase=PHASE3). An unknown parameter is refused by name.

Search parameters

  • querystring

    Words that must all appear in the ingredient, trade name or applicant, e.g. "budesonide foam".

  • ingredientstring

    Active ingredient, substring match, e.g. "tirzepatide".

  • tradeNamestring

    Trade (brand) name, substring match, e.g. "Mounjaro".

  • applicantstring

    Applicant (holder) name, substring match.

  • applicationNumberstring

    NDA or ANDA number, e.g. N215866, NDA 215866, A215328, or N215866-001 for one product.

  • applicationTypestring

    NDA (brand, 505(b)) or ANDA (generic). One of: NDA, ANDA.

  • teCodesstring[]

    TE codes. A two-letter code matches its numbered variants (AB matches AB1, AB2).

  • rldboolean

    true for Reference Listed Drugs only.

  • rsboolean

    true for Reference Standards only.

  • dosageFormstring

    Dosage form, substring match, e.g. "TABLET, EXTENDED RELEASE".

  • routestring

    Route, substring match, e.g. "ORAL", "SUBCUTANEOUS".

  • marketingStatusesstring[]

    RX (prescription), OTC, DISCN (discontinued). Omit for all. One of: RX, OTC, DISCN.

  • hasPatentsboolean

    true: only products with listed patents; false: only products without.

  • patentExpiryFromstring

    Products with a listed patent expiring on or after this date, YYYY-MM-DD.

  • patentExpiryTostring

    Products with a listed patent expiring on or before this date, YYYY-MM-DD.

  • hasExclusivityboolean

    true: only products with listed exclusivities; false: only products without.

  • exclusivityCodesstring[]

    Exclusivity codes: NCE, ODE, PED, NP, NPP, NS, I, D, M, GAIN, CGT, PC. A base code matches its numbered forms (ODE matches ODE-123).

  • exclusivityExpiryFromstring

    Exclusivity expiring on or after this date, YYYY-MM-DD.

  • exclusivityExpiryTostring

    Exclusivity expiring on or before this date, YYYY-MM-DD.

  • approvedFromstring

    Earliest approval date, YYYY-MM-DD.

  • approvedTostring

    Latest approval date, YYYY-MM-DD.

  • sortstring

    relevance (default: RLDs and reference standards first, marketed before discontinued), newest approval first, or patentExpiry (earliest patent expiry in the window first). One of: relevance, newest, patentExpiry.

  • limitinteger

    How many products to return (default 8). total reports every match.

  • offsetinteger

    Skip this many results (for paging), default 0.

Each result is a record; read one in full with Get a record.

What a record holds

  • id, title, url: the source's identifier, its title and its page at the source, to verify it.
  • authority, publishedDate, version: who published it, when, and the edition read.
  • snippet and fields: the matching text and the source's own fields.
  • asOf: the day Assyro's copy of the source was read.