FDA Orange Book

Official Orange Book product, patent, and exclusivity records

Monitor official FDA Orange Book product, patent, exclusivity, and therapeutic-equivalence records. Generate source-linked change alerts, cliff reports, and optional exports.

Not USPTO patent search. Not FDA warning letters. Not 510(k) device clearances. You supply Orange Book watches.

from $5.00 / 1,000 Orange Book product record ($0.005 per delivered orange-book-record-row); $0.35 per Orange Book patent change alert; $0.50 per Orange Book exclusivity change alert; $18.00 per Orange Book patent cliff report; $10.00 per Orange Book evidence export. No Actor Start.

Open FDA Orange Book Patent & Exclusivity Change Report on Apify

FDA Orange Book Patent & Exclusivity Change Report, not a neighboring Actor

Use this page for this Actor’s job. Use FDA Warning Letters Scraper for FDA warning-letter pages; Use USPTO Patent Search Scraper for USPTO patent search; Use FDA 510(k) Device Clearance Landscape Report for FDA 510(k) clearances.

This ActorFDA Warning Letters ScraperUSPTO Patent Search ScraperFDA 510(k) Device Clearance Landscape Report
IntentOrange Book patent/exclusivity changes and cliff reportsFDA warning-letter pagesUSPTO patent searchFDA 510(k) clearances
Primary inputwatchessearch termsquerieswatches
What it readsOfficial FDA Orange Book public filesFDA warning lettersUSPTO public searchFDA 510(k)
Primary outputRecord, patent/exclusivity alerts, cliff report, and export eventsLetter rowsPatent rowsClearance landscape rows
Not this jobNot USPTO patent search. Not FDA warning letters. Not 510(k) device clearances. You supply Orange Book watches.Not Orange Book patents.Not FDA Orange Book exclusivity.Not Orange Book drug patents.

Store ID: taroyamada/fda-orange-book-patent-exclusivity-change-report. Respect source terms, robots.txt, and rate limits.

Use cases

How is FDA Orange Book Patent & Exclusivity Change Report different from FDA Warning Letters Scraper and USPTO Patent Search Scraper?

FDA Orange Book Patent & Exclusivity Change Report (taroyamada/fda-orange-book-patent-exclusivity-change-report): Monitor official FDA Orange Book product, patent, exclusivity, and therapeutic-equivalence records. Generate source-linked change alerts, cliff reports, and optional exports. Not USPTO patent search. Not FDA warning letters. Not 510(k) device clearances. You supply Orange Book watches. FDA Warning Letters Scraper is for FDA warning-letter pages (input search terms; FDA warning letters; Letter rows). Not Orange Book patents. USPTO Patent Search Scraper is for USPTO patent search (input queries; USPTO public search; Patent rows). Not FDA Orange Book exclusivity. FDA 510(k) Device Clearance Landscape Report is for FDA 510(k) clearances (input watches; FDA 510(k); Clearance landscape rows). Not Orange Book drug patents.

What input is required?

Live required fields: watches. Published exampleRunInput is shown below.

Field Type Default Notes
watches any[] [] Orange Book watches. Each watch needs at least one bounded product, patent, exclusivity, or TE-code filter. Use stable ids for recurring monitoring. Required.
monitorKey string "fda-orange-book-lifecycle-watch" Monitor key. Stable isolated state namespace for a recurring product lifecycle watch.
initialRunMode string enum "baseline_only" Initial run mode. baseline_only stores the first snapshot with zero rows; emit_backfill emits the current matched records for an explicit first report. enum: baseline_only, emit_backfill
generateReport boolean true Generate patent cliff report. Generate one descriptive report for changed records and patent/exclusivity dates within cliffWindowDays. It is not a legal conclusion or launch forecast.
generateCliffReport boolean true Include date-window report. Keep the report event enabled when generateReport is true.
emitRawRows boolean false Emit product rows. Emit lower-priced normalized product rows for changed or explicitly backfilled records.
emitExport boolean false Generate evidence export. Generate a compact source-linked JSON export when changed or backfilled records are selected.
emitUnchanged boolean false Emit unchanged records. Accepted for compatibility, but unchanged records always emit zero rows and zero charge.
cliffWindowDays integer 730 Date-window days. The forward-looking date window used only to group reported patent and exclusivity dates. minimum=1 maximum=3650
maxRecordsPerWatch integer 25 Maximum records per watch. Each openFDA request is capped below the official API maximum of 99 records. minimum=1 maximum=99
maxRequests integer 10 Maximum API requests. Hard upper bound on watch requests per run. minimum=1 maximum=25
maxChargeUsd number 75 Maximum charge USD. Fail closed before delivery if planned PPE charges exceed this cap. minimum=0.005 maximum=500
dryRun boolean false Dry run. Return representative event rows without calling openFDA, saving state, or charging PPE events.

Published Store example run input (omitted fields take schema defaults):

{
  "watches": [
    {
      "id": "near-term-patent-and-exclusivity-watch",
      "applicationTypes": [
        "N"
      ],
      "patentExpirationFrom": "2026-01-01",
      "patentExpirationTo": "2028-12-31",
      "exclusivityExpirationFrom": "2026-01-01",
      "exclusivityExpirationTo": "2028-12-31"
    }
  ],
  "maxRecordsPerWatch": 3,
  "maxRequests": 3,
  "maxChargeUsd": 3,
  "dryRun": false
}

Run FDA Orange Book Patent & Exclusivity Change Report on Apify

How do dataset, webhook, and dry-run delivery work?

Dataset output is the billable surface when rows are written. See live PPE for which events bill. dryRun true validates or samples without the usual dataset/webhook side effects described on the Store schema. Unchanged runs that write zero default-dataset rows typically charge $0.00 on current PPE.

What does a result contain?

Published README Output Example / Sample Output JSON. Treat README samples as illustrations, not a live coverage guarantee. There is no published output JSON schema on the Store page.

How is FDA Orange Book Patent & Exclusivity Change Report priced?

Billing is pay per event. The live Store card is from $5.00 / 1,000 Orange Book product record ($0.005 per delivered orange-book-record-row); $0.35 per Orange Book patent change alert; $0.50 per Orange Book exclusivity change alert; $18.00 per Orange Book patent cliff report; $10.00 per Orange Book evidence export. No Actor Start. Current PPE:

Event Price Emitted when
orange-book-record-row (Orange Book product record) $0.005 Charged only when a orange book product record row is delivered.
orange-book-patent-change-alert (Orange Book patent change alert) $0.35 Charged only when a orange book patent change alert row is delivered.
orange-book-exclusivity-change-alert (Orange Book exclusivity change alert) $0.50 Charged only when a orange book exclusivity change alert row is delivered.
orange-book-patent-cliff-report (Orange Book patent cliff report) $18.00 Charged only when a orange book patent cliff report row is delivered.
orange-book-export (Orange Book evidence export) $10.00 Charged only when a orange book evidence export row is delivered.

from $5.00 / 1,000 Orange Book product record ($0.005 per delivered orange-book-record-row); $0.35 per Orange Book patent change alert; $0.50 per Orange Book exclusivity change alert; $18.00 per Orange Book patent cliff report; $10.00 per Orange Book evidence export. No Actor Start.

See FDA Orange Book Patent & Exclusivity Change Report pricing on Apify

Limits to keep in mind

Open FDA Orange Book Patent & Exclusivity Change Report on Apify

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