FDA Orange Book — Patent Expirations

Returns one row per drug-patent pair from the current FDA Orange Book quarterly export, with expiration date, applicant, active ingredient, and all Orange Book flags (drug substance, drug product, use code, delist). Built for pharma competitive intel, generic-launch timing, and IP due diligence.

Example output

{
  "appl_type": "N",
  "appl_no": "020610",
  "product_no": "001",
  "drug_name": "COLAZAL",
  "active_ingredient": "BALSALAZIDE DISODIUM",
  "dosage_form_route": "CAPSULE;ORAL",
  "strength": "750MG",
  "te_code": "AB",
  "rld": true,
  "rs": true,
  "rx_or_otc": "RX",
  "applicant_short": "VALEANT PHARMS INTL",
  "applicant_full": "VALEANT PHARMACEUTICALS INTERNATIONAL",
  "approval_date": "Jul 18, 2000",
  "patent_no": "7625884",
  "patent_expire_date": "2026-08-24",
  "patent_expire_date_raw": "Aug 24, 2026",
  "drug_substance_flag": false,
  "drug_product_flag": false,
  "patent_use_code": "U-141",
  "delisted": false,
  "patent_submission_date": "",
  "source_file_version": "2026_03",
  "source_url": "https://www.fda.gov/media/76860/download",
  "retrieved_at": "2026-04-17T16:31:17.013Z"
}

(Copy-paste from a local run against EOBZIP_2026_03.zip, 2026-04-17.)

Input

Field	Type	Default	Description
applicantFilter	string	""	Substring match on applicant name.
activeIngredientFilter	string	""	Substring match on active ingredient.
expireAfter	date	""	ISO YYYY-MM-DD lower bound on patent expiration.
expireBefore	date	""	ISO YYYY-MM-DD upper bound on patent expiration.
maxResults	integer	500	Hard cap on rows emitted.
includeDelisted	boolean	false	Include rows with delist_flag=Y.

All fields are optional. Running with defaults returns the first 500 currently-listed patent rows across the full Orange Book.

Pricing

Pay-per-Event: $0.05 per result ($50 per 1,000) via the built-in apify-default-dataset-item event. First-ship launch anchor on the low end of the Standard tier band ($0.05–$0.20/result) for narrow regulatory/B2B data — held for a one-month observation window, then adjusted on signal. Rationale: the source is regulated, time-sensitive, and requires cross-file joins that commoditized scrapers don't perform; the old $1.50–$3.00/1K norm was 33–133× under-priced for this data class.

Source

Upstream: FDA Orange Book Data Files. The canonical download redirect is https://www.fda.gov/media/76860/download, which serves the current monthly cumulative zip (e.g. EOBZIP_2026_03.zip). The archive contains tilde-delimited (~) products.txt, patent.txt, and exclusivity.txt. This Actor fetches the redirect on every run, unzips in-memory, left-joins patent.txt ↔ products.txt on (Appl_No, Product_No), applies user filters, and emits one row per drug-patent pair.

Freshness

FDA updates the Orange Book quarterly (Jan / Apr / Jul / Oct), plus cumulative monthly supplements. Run this Actor monthly to catch supplements; the source_file_version field in every emitted row reports the exact YYYY_MM of the zip the data came from so downstream consumers can dedupe across runs.

Notes

Built natively for 2026's Apify Pay-per-Event pricing model. Zero migration cost when the platform's rental-Actor sunset completes on 2026-10-01. No OAuth, no CAPTCHA — the source is a public regulatory data file served over HTTPS.