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Search FDA Purple Book

Search and read FDA Purple Book records through the Assyro API: licensed biologics, biosimilars, interchangeability and reference product exclusivity.

GEThttps://api.assyro.com/v1/sources/purple-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 Purple Book records from your own code: licensed biologics, biosimilars, interchangeability and reference product exclusivity. Published by U.S. Food and Drug Administration (purplebooksearch.fda.gov); 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 biosimilars are interchangeable with Humira?"

GET https://api.assyro.com/v1/sources/purple-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 proprietary name, proper name, applicant or reference product, e.g. "adalimumab".

  • proprietaryNamestring

    Brand name, substring match, e.g. "Humira".

  • properNamestring

    Proper (nonproprietary) name, substring match, e.g. "adalimumab-afzb" or "adalimumab".

  • applicantstring

    License holder, substring match.

  • blaNumberstring

    BLA number, e.g. 125057 or BLA 761118.

  • licenseTypesstring[]

    351(a) (reference or standalone BLA), biosimilar (351(k)), interchangeable (351(k) interchangeable). Omit for all. One of: 351(a), biosimilar, interchangeable.

  • referenceProductstring

    Reference product brand or proper name, e.g. "Humira": returns the 351(k) products that reference it.

  • centersstring[]

    CDER or CBER. One of: CDER, CBER.

  • licensureStatusesstring[]

    licensed, revoked, voluntarily revoked. Omit for all. One of: licensed, revoked, voluntarily revoked.

  • marketingStatusesstring[]

    RX, OTC, DISC (discontinued). A BLA matches when any presentation has the status. One of: RX, OTC, DISC.

  • approvedFromstring

    Earliest original approval date, YYYY-MM-DD.

  • approvedTostring

    Latest original approval date, YYYY-MM-DD.

  • exclusivityExpiryFromstring

    Any exclusivity (reference product, first interchangeable, orphan) expiring on or after this date, YYYY-MM-DD.

  • exclusivityExpiryTostring

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

  • hasPatentListboolean

    true: only BLAs for which a patent list was provided.

  • sortstring

    relevance (default: licensed 351(a) products first, then newest), newest or oldest approval first. One of: relevance, newest, oldest.

  • limitinteger

    How many BLAs 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.