FDA Orange Book

Track FDA Orange Book drug patents and exclusivity data. Built for IP counsel, brand teams, researchers and AI agents.

Factual public data — not financial or investment advice.

📊 Sample Output

ingredient	tradeName	dosageFormRoute	applicant	applicantFullName	applicationTypeLabel
APIXABAN	ELIQUIS SPRINKLE	FOR SUSPENSION;ORAL	BRISTOL	BRISTOL MYERS SQUIBB CO	NDA (brand / innovator)
APIXABAN	ELIQUIS	TABLET, FOR SUSPENSION;ORAL	BRISTOL MYERS SQUIBB	BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE	NDA (brand / innovator)
APIXABAN	APIXABAN	TABLET;ORAL	ACCORD HLTHCARE	ACCORD HEALTHCARE INC	ANDA (generic)
APIXABAN	APIXABAN	TABLET;ORAL	ACCORD HLTHCARE	ACCORD HEALTHCARE INC	ANDA (generic)
APIXABAN	APIXABAN	TABLET;ORAL	APOTEX	APOTEX INC	ANDA (generic)
APIXABAN	APIXABAN	TABLET;ORAL	APOTEX	APOTEX INC	ANDA (generic)

Real rows from run QZBHZ8ZjhthmR03sM on build 0.0.21 (2026-09-25), unedited apart from masked emails/phones and shortened long text; fields the source does not publish are empty.

🔧 Input reference

Field	Type	Default	What it does
ingredient	string	"apixaban"	Filter by active ingredient (contains, case-insensitive). E.g. 'apixaban', 'semaglutide'.
tradeName	string		Filter by brand name (contains, case-insensitive). E.g. 'Eliquis', 'Ozempic'.
applicant	string		Filter by applicant company name (contains, case-insensitive). E.g. 'Pfizer', 'Teva'.
applicationNumber	string		Exact NDA/ANDA application number, e.g. '202155'.
applicationType	array of string		N = NDA (brand/innovator), A = ANDA (generic).
marketingStatus	array of string		RX = prescription, OTC = over-the-counter, DISCN = discontinued.
onlyWithUnexpiredPatents	boolean	false	Return only products that still have at least one patent not yet expired.
patentExpiringAfter	string		Keep products with a patent expiring on/after this date (YYYY-MM-DD).
patentExpiringBefore	string		Keep products with a patent expiring on/before this date (YYYY-MM-DD). Useful for finding near-term generic opportunities.
includePatents	boolean	true	Include the full array of listed patents per product.
includeExclusivity	boolean	true	Include the full array of FDA exclusivity entries per product.
maxResults	integer	1000	Maximum number of drug-product records to return.

🧾 JSON sample record

One real record from run QZBHZ8ZjhthmR03sM (emails/phones masked, long text shortened):

{
  "ingredient": "APIXABAN",
  "tradeName": "ELIQUIS SPRINKLE",
  "dosageFormRoute": "FOR SUSPENSION;ORAL",
  "strength": "0.15MG",
  "applicant": "BRISTOL",
  "applicantFullName": "BRISTOL MYERS SQUIBB CO",
  "applicationType": "N",
  "applicationTypeLabel": "NDA (brand / innovator)",
  "applicationNumber": "220073",
  "productNumber": "001",
  "teCode": null,
  "approvalDate": "2025-04-17",
  "approvalDateText": "Apr 17, 2025",
  "referenceListedDrug": true,
  "referenceStandard": true,
  "marketingStatus": "RX",
  "marketingStatusLabel": "Prescription",
  "patentCount": 4,
  "exclusivityCount": 2,
  "earliestProtectionExpiry": "2026-11-21",
  "estimatedGenericEntryDate": "2041-05-22",
  "hasUnexpiredProtection": true,
  "sourceUrl": "https://www.accessdata.fda.gov/scripts/cder/ob/results_product.cfm?Appl_Type=N&Appl_No=220073",
  "patents": [
    {
      "patentNumber": "11896586",
      "expireDate": "2040-11-22",
      "expireDateText": "Nov 22, 2040",
      "drugSubstance": false,
      "drugProduct": true,
      "patentUseCode": "U-4180",
      "delisted": false,
      "submissionDate": "2025-05-16"
    },
    {
      "patentNumber": "6967208",
      "expireDate": "2026-11-21",
      "expireDateText": "Nov 21, 2026",
      "drugSubstance": true,
      "drugProduct": true,
      "patentUseCode": "U-4180",
      "delisted": false,
      "submissionDate": "2025-05-16"
    },
    {
      "patentNumber": "11896586*PED",
      "expireDate": "2041-05-22",
      "expireDateText": "May 22, 2041",
      "drugSubstance": false,
      "drugProduct": false,
      "patentUseCode": null,
      "delisted": false,
      "submissionDate": null
    },
    {
      "patentNumber": "6967208*PED",
      "expireDate": "2027-05-21",
      "expireDateText": "May 21, 2027",
      "drugSubstance": false,
      "drugProduct": false,
      "patentUseCode": null,
      "delisted": false,
      "submissionDate": null
    }
  ],
  "exclusivities": [
    {
      "exclusivityCode": "NP",
      "expireDate": "2028-04-17"
    },
    {
      "exclusivityCode": "PED",
      "expireDate": "2028-10-17"
    }
  ]
}

💰 Pricing

Event	Price (USD)	When it is charged
Actor Start (apify-actor-start)	$5e-05	Charged when the Actor starts running. Number of events charged depends on Actor memory (one event per GB, minimum one event).
Drug patent record (apify-default-dataset-item)	$0.1	Single result in the default dataset.

Pay-per-event: you pay only for what the run delivers. A run that delivers nothing bills no result events (only the actor-start event, when the actor defines one). Example: a run that delivers 100 results costs 100 × $0.1 = $10.00 plus the start fee.

🔗 Related Actors

More from the NexGenData Healthcare & FDA family:

• FDA Adverse Events — FAERS & MAUDE Records API
• FDA Drug Approvals Tracker — NDA/BLA/ANDA API
• FDA Drug Shortages Monitor — Current & Resolved API
• FDA Pharma Pipeline Tracker — Milestone Data API
• FDA Purple Book — Biologics & Biosimilars API
• FDA Recall Monitor — Drug & Device Safety Alerts

15 more in this family on the NexGenData Store page.

⏰ Run this as a patent-cliff watch (recommended)

Every IP registry actor is a monitoring subscription, not a one-shot lookup. Schedule a weekly sweep and catch new filings as they land:

{
  "query": "drug name",
  "limit": 100
}

Weekly cron (0 8 * * 1) turns this into an always-on patent-cliff watch.

📊 What you get

Clean JSON, one record per record (full output has 25 fields):

• applicant — Applicant
• applicantFullName — Applicant Full Name
• applicationNumber — Application Number
• applicationType — Application Type
• applicationTypeLabel — Application Type Label
• approvalDate — Approval Date
• approvalDateText — Approval Date Text
• dosageFormRoute — Dosage Form Route
• earliestProtectionExpiry — Earliest Protection Expiry
• estimatedGenericEntryDate — Estimated Generic Entry Date

Pricing: $0.10 per record (Pay-Per-Event) — about 10 records per $1.

🤖 Use with AI agents

Point Claude, the OpenAI Agents SDK, an n8n flow or any MCP-aware client at it and run FDA Orange Book drug patents and exclusivity on demand.

Sample agent prompt:

List Orange Book patents expiring for a drug and its exclusivity dates.

Agentic payments (x402): Supports agentic payment via x402 — agents can call this actor with USDC, no API key required.

🔗 Related IP actors

Prior-art & patent web: USPTO Patent Search, USPTO Patent Grants, USPTO Grants Tracker, WIPO PatentScope, PatentsView Inventors

IP agent front door: Patents & Trademarks IP MCP

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Data from public intellectual-property registries. Factual public data — not financial or investment advice.