ASassyro
FDA Purple Book

Search FDA Purple Book

Search the FDA Purple Book: every licensed biological product (CDER and CBER) with its license type (351(a) reference or standalone, 351(k) biosimilar, 351(k) interchangeable), reference product, approval, interchangeability and first licensure dates, and reference product, first interchangeable and orphan exclusivity expiry dates. Use it for biosimilar and interchangeable landscape questions (which biosimilars reference Humira, which are interchangeable, when reference product exclusivity ends), licensure history, and whether a patent list was provided. Data comes from FDA's monthly Purple Book download, not the live site: each record's version is the edition (YYYY-MM). State that edition. The download carries no patent numbers; for those, send the user to the patent list page named in the read result. Cite each product by its BLA number (for example BLA 761118). Read a product to see its reference product or the biosimilars that reference it. Give at least one filter; a search with sort newest and no filter lists the latest approvals.

get/v1/sources/purple-book/search

Request

  • Base URL
    https://api.assyro.com
  • Auth
    none declared

Query 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.

referenceProductstring

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

centersstring[]

CDER or CBER.

licensureStatusesstring[]

licensed, revoked, voluntarily revoked. Omit for all.

marketingStatusesstring[]

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

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.

sort'relevance' | 'newest' | 'oldest'

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

limitinteger

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

offsetinteger

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

Response

Matching records.

versionunknown required
totalinteger nullable required

Total matches the source reports, when it says.

notestring
summarystring[]

Changes

No recorded changes to this operation across all 1 revision of this API.