FDA Orange Book Patent & Exclusivity Change Report

Pharma product, regulatory-operations, and lifecycle teams provide bounded Orange Book filters and receive a source-linked comparison of FDA product, patent, exclusivity, and therapeutic-equivalence records. The input is a stable watch with application, product, patent, exclusivity, or TE-code filters; the output is a change alert, date-window report, and optional JSON evidence export. The Actor uses the official openFDA Orange Book endpoint with no API key, login, browser automation, or private data.

Store Quickstart

1. Run the first watch with initialRunMode: "baseline_only" to save the current public snapshot with zero rows and zero charge.
2. Run the same watch later with the same monitorKey and stable watch id to receive only changed records.
3. For an intentional first report, use initialRunMode: "emit_backfill", generateCliffReport: true, and emitExport: true.

Run the next report

Use the report output for product-lifecycle review, then compare related public supply records with FDA Drug Shortage Supply Change Report.

Example 1: near-term patent and exclusivity dates

{
  "watches": [{
    "id": "near-term-dates",
    "applicationTypes": ["N"],
    "patentExpirationFrom": "2026-01-01",
    "patentExpirationTo": "2028-12-31",
    "exclusivityExpirationFrom": "2026-01-01",
    "exclusivityExpirationTo": "2028-12-31"
  }],
  "monitorKey": "lifecycle-dates",
  "initialRunMode": "baseline_only",
  "generateReport": true,
  "emitUnchanged": false
}

Example 2: one application and TE code

{
  "watches": [{
    "id": "nda-205776",
    "applicationNumbers": ["205776"],
    "therapeuticEquivalenceCodes": ["AB", "AP"]
  }],
  "monitorKey": "nda-205776-review",
  "initialRunMode": "emit_backfill",
  "generateReport": true,
  "generateCliffReport": true,
  "emitExport": true,
  "maxChargeUsd": 75
}

Example 3: patent-use and exclusivity watch

{
  "watches": [{
    "id": "selected-patents",
    "patentNumbers": ["8664231", "9999999"],
    "exclusivityCodes": ["NCE", "ODE"]
  }],
  "monitorKey": "selected-patent-portfolio",
  "initialRunMode": "baseline_only",
  "generateReport": true,
  "emitExport": true,
  "cliffWindowDays": 1095
}

Outputs and pricing

The report and evidence events are the primary product. Raw product rows are optional and lower priced.

Event	Price	Output
orange-book-record-row	$0.005	One normalized product record joined with patent, exclusivity, and TE-code fields
orange-book-patent-change-alert	$0.35	One source-linked public patent-field change alert
orange-book-exclusivity-change-alert	$0.50	One source-linked public exclusivity-field change alert
orange-book-patent-cliff-report	$18	A descriptive date-window and change report
orange-book-export	$10	A compact JSON evidence export

The first baseline_only run and later unchanged runs emit zero rows and zero charge. Delivery fails closed if an event is unknown, the planned charge exceeds maxChargeUsd, charge proof is missing, or state cannot be saved after successful delivery.

What changes mean

• record_added: a matching public record was not in the previous snapshot.
• patent_changed: one or more public patent fields changed.
• exclusivity_changed: one or more public exclusivity fields changed.
• patent_and_exclusivity_changed: both joined sections changed.
• therapeutic_equivalence_changed: the public TE-code set changed.
• record_changed: another joined product field changed.

The word “cliff” describes a configurable date window in the report. It is not a statement about patent validity, enforceability, approval, launch timing, market entry, or commercial availability.

Compliance guardrails

• Official source only: https://api.fda.gov/drug/orangebook.json and the FDA Orange Book pages linked in docs/source-compliance.md.
• No API key or login is required. The Actor does not use browser automation, private FDA systems, or access-bypass behavior.
• Product, patent, exclusivity, and TE-code values are reproduced as public source data and linked to the retrieval query.
• No legal, patent-validity, infringement, medical, investment, market-access, pricing, launch, or procurement advice.
• Do not treat a listed patent or date as a guarantee. Verify the FDA source and consult qualified professionals for decisions outside descriptive analysis.

Integration

See docs/integration-guide.md for recurring state-safe monitoring and docs/sample-output.json for the report/alert/export contract.

See also

• FDA Drug Shortage Supply Change Report for a separate public supply-record change workflow.

This Actor is limited to Orange Book product, patent, exclusivity, and TE-code observations. It does not infer supply, approval, validity, or launch outcomes.