# FDA Orange Book Patent & Exclusivity Change Report (`taroyamada/fda-orange-book-patent-exclusivity-change-report`) Actor Monitor official FDA Orange Book product, patent, exclusivity, and therapeutic-equivalence records. Generate source-linked change alerts, date-window reports, and JSON exports without an API key or login. Outputs are descriptive public data, not legal conclusions or launch forecasts. - **URL**: https://apify.com/taroyamada/fda-orange-book-patent-exclusivity-change-report.md - **Developed by:** [naoki anzai](https://apify.com/taroyamada) (community) - **Categories:** Business - **Stats:** 2 total users, 1 monthly users, 0.0% runs succeeded, 0 bookmarks - **User rating**: No ratings yet ## Pricing from $5.00 / 1,000 orange book product records This Actor is paid per event. You are not charged for the Apify platform usage, but only a fixed price for specific events. Learn more: https://docs.apify.com/platform/actors/running/actors-in-store#pay-per-event ## What's an Apify Actor? Actors are web data automations that power AI and operations. They run on the Apify platform to scrape websites, process data, connect APIs, and automate workflows. In Batch mode, an Actor accepts a well-defined JSON input, performs an action which can take anything from a few seconds to a few hours, and optionally produces a well-defined JSON output, datasets with results, or files in key-value store. In Standby mode, an Actor provides a web server which can be used as a website, API, or an MCP server. Actors are written with capital "A". ## How to integrate an Actor? If asked about integration, you help developers integrate Actors into their projects. You adapt to their stack and deliver integrations that are safe, well-documented, and production-ready. The best way to integrate Actors is as follows. In JavaScript/TypeScript projects, use official [JavaScript/TypeScript client](https://docs.apify.com/api/client/js/docs.md): ```bash npm install apify-client ``` In Python projects, use official [Python client library](https://docs.apify.com/api/client/python/docs.md): ```bash pip install apify-client ``` In shell scripts, use [Apify CLI](https://docs.apify.com/cli/docs.md): ````bash # MacOS / Linux curl -fsSL https://apify.com/install-cli.sh | bash # Windows irm https://apify.com/install-cli.ps1 | iex ```bash In AI frameworks, you might use the [Apify MCP server](https://docs.apify.com/integrations/mcp.md). If your project is in a different language, use the [REST API](https://docs.apify.com/api/v2.md). For usage examples, see the [API](#api) section below. For more details, see Apify documentation as [Markdown index](https://docs.apify.com/llms.txt) and [Markdown full-text](https://docs.apify.com/llms-full.txt). # README ## 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](https://apify.com/taroyamada/fda-drug-shortage-supply-change-report). ### Example 1: near-term patent and exclusivity dates ```json { "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 ```json { "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 ```json { "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 β€œcliff” 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](docs/integration-guide.md) for recurring state-safe monitoring and [docs/sample-output.json](docs/sample-output.json) for the report/alert/export contract. ### See also - [FDA Drug Shortage Supply Change Report](https://apify.com/taroyamada/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. # Actor input Schema ## `watches` (type: `array`): Each watch needs at least one bounded product, patent, exclusivity, or TE-code filter. Use stable ids for recurring monitoring. ## `monitorKey` (type: `string`): Stable isolated state namespace for a recurring product lifecycle watch. ## `initialRunMode` (type: `string`): baseline\_only stores the first snapshot with zero rows; emit\_backfill emits the current matched records for an explicit first report. ## `generateReport` (type: `boolean`): Generate one descriptive report for changed records and patent/exclusivity dates within cliffWindowDays. It is not a legal conclusion or launch forecast. ## `generateCliffReport` (type: `boolean`): Keep the report event enabled when generateReport is true. ## `emitRawRows` (type: `boolean`): Emit lower-priced normalized product rows for changed or explicitly backfilled records. ## `emitExport` (type: `boolean`): Generate a compact source-linked JSON export when changed or backfilled records are selected. ## `emitUnchanged` (type: `boolean`): Accepted for compatibility, but unchanged records always emit zero rows and zero charge. ## `cliffWindowDays` (type: `integer`): The forward-looking date window used only to group reported patent and exclusivity dates. ## `maxRecordsPerWatch` (type: `integer`): Each openFDA request is capped below the official API maximum of 99 records. ## `maxRequests` (type: `integer`): Hard upper bound on watch requests per run. ## `maxChargeUsd` (type: `number`): Fail closed before delivery if planned PPE charges exceed this cap. ## `dryRun` (type: `boolean`): Return representative event rows without calling openFDA, saving state, or charging PPE events. ## Actor input object example ```json { "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" } ], "monitorKey": "fda-orange-book-lifecycle-watch", "initialRunMode": "baseline_only", "generateReport": true, "generateCliffReport": true, "emitRawRows": false, "emitExport": false, "emitUnchanged": false, "cliffWindowDays": 730, "maxRecordsPerWatch": 25, "maxRequests": 10, "maxChargeUsd": 75, "dryRun": false } ``` # API You can run this Actor programmatically using our API. Below are code examples in JavaScript, Python, and CLI, as well as the OpenAPI specification and MCP server setup. ## JavaScript example ```javascript import { ApifyClient } from 'apify-client'; // Initialize the ApifyClient with your Apify API token // Replace the '' with your token const client = new ApifyClient({ token: '', }); // Prepare Actor input const input = { "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" } ] }; // Run the Actor and wait for it to finish const run = await client.actor("taroyamada/fda-orange-book-patent-exclusivity-change-report").call(input); // Fetch and print Actor results from the run's dataset (if any) console.log('Results from dataset'); console.log(`πŸ’Ύ Check your data here: https://console.apify.com/storage/datasets/${run.defaultDatasetId}`); const { items } = await client.dataset(run.defaultDatasetId).listItems(); items.forEach((item) => { console.dir(item); }); // πŸ“š Want to learn more πŸ“–? Go to β†’ https://docs.apify.com/api/client/js/docs ``` ## Python example ```python from apify_client import ApifyClient # Initialize the ApifyClient with your Apify API token # Replace '' with your token. client = ApifyClient("") # Prepare the Actor input run_input = { "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", }] } # Run the Actor and wait for it to finish run = client.actor("taroyamada/fda-orange-book-patent-exclusivity-change-report").call(run_input=run_input) # Fetch and print Actor results from the run's dataset (if there are any) print("πŸ’Ύ Check your data here: https://console.apify.com/storage/datasets/" + run["defaultDatasetId"]) for item in client.dataset(run["defaultDatasetId"]).iterate_items(): print(item) # πŸ“š Want to learn more πŸ“–? Go to β†’ https://docs.apify.com/api/client/python/docs/quick-start ``` ## CLI example ```bash echo '{ "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" } ] }' | apify call taroyamada/fda-orange-book-patent-exclusivity-change-report --silent --output-dataset ``` ## MCP server setup ```json { "mcpServers": { "apify": { "command": "npx", "args": [ "mcp-remote", "https://mcp.apify.com/?tools=taroyamada/fda-orange-book-patent-exclusivity-change-report", "--header", "Authorization: Bearer " ] } } } ``` ## OpenAPI specification ```json { "openapi": "3.0.1", "info": { "title": "FDA Orange Book Patent & Exclusivity Change Report", "description": "Monitor official FDA Orange Book product, patent, exclusivity, and therapeutic-equivalence records. Generate source-linked change alerts, date-window reports, and JSON exports without an API key or login. Outputs are descriptive public data, not legal conclusions or launch forecasts.", "version": "0.1", "x-build-id": "UdM9inSxfo5HTQB9Y" }, "servers": [ { "url": "https://api.apify.com/v2" } ], "paths": { "/acts/taroyamada~fda-orange-book-patent-exclusivity-change-report/run-sync-get-dataset-items": { "post": { "operationId": "run-sync-get-dataset-items-taroyamada-fda-orange-book-patent-exclusivity-change-report", "x-openai-isConsequential": false, "summary": "Executes an Actor, waits for its completion, and returns Actor's dataset items in response.", "tags": [ "Run Actor" ], "requestBody": { "required": true, "content": { "application/json": { "schema": { "$ref": "#/components/schemas/inputSchema" } } } }, "parameters": [ { "name": "token", "in": "query", "required": true, "schema": { "type": "string" }, "description": "Enter your Apify token here" } ], "responses": { "200": { "description": "OK" } } } }, "/acts/taroyamada~fda-orange-book-patent-exclusivity-change-report/runs": { "post": { "operationId": "runs-sync-taroyamada-fda-orange-book-patent-exclusivity-change-report", "x-openai-isConsequential": false, "summary": "Executes an Actor and returns information about the initiated run in response.", "tags": [ "Run Actor" ], "requestBody": { "required": true, "content": { "application/json": { "schema": { "$ref": "#/components/schemas/inputSchema" } } } }, "parameters": [ { "name": "token", "in": "query", "required": true, "schema": { "type": "string" }, "description": "Enter your Apify token here" } ], "responses": { "200": { "description": "OK", "content": { "application/json": { "schema": { "$ref": "#/components/schemas/runsResponseSchema" } } } } } } }, "/acts/taroyamada~fda-orange-book-patent-exclusivity-change-report/run-sync": { "post": { "operationId": "run-sync-taroyamada-fda-orange-book-patent-exclusivity-change-report", "x-openai-isConsequential": false, "summary": "Executes an Actor, waits for completion, and returns the OUTPUT from Key-value store in response.", "tags": [ "Run Actor" ], "requestBody": { "required": true, "content": { "application/json": { "schema": { "$ref": "#/components/schemas/inputSchema" } } } }, "parameters": [ { "name": "token", "in": "query", "required": true, "schema": { "type": "string" }, "description": "Enter your Apify token here" } ], "responses": { "200": { "description": "OK" } } } } }, "components": { "schemas": { "inputSchema": { "type": "object", "required": [ "watches" ], "properties": { "watches": { "title": "Orange Book watches", "type": "array", "description": "Each watch needs at least one bounded product, patent, exclusivity, or TE-code filter. Use stable ids for recurring monitoring.", "default": [] }, "monitorKey": { "title": "Monitor key", "type": "string", "description": "Stable isolated state namespace for a recurring product lifecycle watch.", "default": "fda-orange-book-lifecycle-watch" }, "initialRunMode": { "title": "Initial run mode", "enum": [ "baseline_only", "emit_backfill" ], "type": "string", "description": "baseline_only stores the first snapshot with zero rows; emit_backfill emits the current matched records for an explicit first report.", "default": "baseline_only" }, "generateReport": { "title": "Generate patent cliff report", "type": "boolean", "description": "Generate one descriptive report for changed records and patent/exclusivity dates within cliffWindowDays. It is not a legal conclusion or launch forecast.", "default": true }, "generateCliffReport": { "title": "Include date-window report", "type": "boolean", "description": "Keep the report event enabled when generateReport is true.", "default": true }, "emitRawRows": { "title": "Emit product rows", "type": "boolean", "description": "Emit lower-priced normalized product rows for changed or explicitly backfilled records.", "default": false }, "emitExport": { "title": "Generate evidence export", "type": "boolean", "description": "Generate a compact source-linked JSON export when changed or backfilled records are selected.", "default": false }, "emitUnchanged": { "title": "Emit unchanged records", "type": "boolean", "description": "Accepted for compatibility, but unchanged records always emit zero rows and zero charge.", "default": false }, "cliffWindowDays": { "title": "Date-window days", "minimum": 1, "maximum": 3650, "type": "integer", "description": "The forward-looking date window used only to group reported patent and exclusivity dates.", "default": 730 }, "maxRecordsPerWatch": { "title": "Maximum records per watch", "minimum": 1, "maximum": 99, "type": "integer", "description": "Each openFDA request is capped below the official API maximum of 99 records.", "default": 25 }, "maxRequests": { "title": "Maximum API requests", "minimum": 1, "maximum": 25, "type": "integer", "description": "Hard upper bound on watch requests per run.", "default": 10 }, "maxChargeUsd": { "title": "Maximum charge USD", "minimum": 0.005, "maximum": 500, "type": "number", "description": "Fail closed before delivery if planned PPE charges exceed this cap.", "default": 75 }, "dryRun": { "title": "Dry run", "type": "boolean", "description": "Return representative event rows without calling openFDA, saving state, or charging PPE events.", "default": false } } }, "runsResponseSchema": { "type": "object", "properties": { "data": { "type": "object", "properties": { "id": { "type": "string" }, "actId": { "type": "string" }, "userId": { "type": "string" }, "startedAt": { "type": "string", "format": "date-time", "example": "2025-01-08T00:00:00.000Z" }, "finishedAt": { "type": "string", "format": "date-time", "example": "2025-01-08T00:00:00.000Z" }, "status": { "type": "string", "example": "READY" }, "meta": { "type": "object", "properties": { "origin": { "type": "string", "example": "API" }, "userAgent": { "type": "string" } } }, "stats": { "type": "object", "properties": { "inputBodyLen": { "type": "integer", "example": 2000 }, "rebootCount": { "type": "integer", "example": 0 }, "restartCount": { "type": "integer", "example": 0 }, "resurrectCount": { "type": "integer", "example": 0 }, "computeUnits": { "type": "integer", "example": 0 } } }, "options": { "type": "object", "properties": { "build": { "type": "string", "example": "latest" }, "timeoutSecs": { "type": "integer", "example": 300 }, "memoryMbytes": { "type": "integer", "example": 1024 }, "diskMbytes": { "type": "integer", "example": 2048 } } }, "buildId": { "type": "string" }, "defaultKeyValueStoreId": { "type": "string" }, "defaultDatasetId": { "type": "string" }, "defaultRequestQueueId": { "type": "string" }, "buildNumber": { "type": "string", "example": "1.0.0" }, "containerUrl": { "type": "string" }, "usage": { "type": "object", "properties": { "ACTOR_COMPUTE_UNITS": { "type": "integer", "example": 0 }, "DATASET_READS": { "type": "integer", "example": 0 }, "DATASET_WRITES": { "type": "integer", "example": 0 }, "KEY_VALUE_STORE_READS": { "type": "integer", "example": 0 }, "KEY_VALUE_STORE_WRITES": { "type": "integer", "example": 1 }, "KEY_VALUE_STORE_LISTS": { "type": "integer", "example": 0 }, "REQUEST_QUEUE_READS": { "type": "integer", "example": 0 }, "REQUEST_QUEUE_WRITES": { "type": "integer", "example": 0 }, "DATA_TRANSFER_INTERNAL_GBYTES": { "type": "integer", "example": 0 }, "DATA_TRANSFER_EXTERNAL_GBYTES": { "type": "integer", "example": 0 }, "PROXY_RESIDENTIAL_TRANSFER_GBYTES": { "type": "integer", "example": 0 }, "PROXY_SERPS": { "type": "integer", "example": 0 } } }, "usageTotalUsd": { "type": "number", "example": 0.00005 }, "usageUsd": { "type": "object", "properties": { "ACTOR_COMPUTE_UNITS": { "type": "integer", "example": 0 }, "DATASET_READS": { "type": "integer", "example": 0 }, "DATASET_WRITES": { "type": "integer", "example": 0 }, "KEY_VALUE_STORE_READS": { "type": "integer", "example": 0 }, "KEY_VALUE_STORE_WRITES": { "type": "number", "example": 0.00005 }, "KEY_VALUE_STORE_LISTS": { "type": "integer", "example": 0 }, "REQUEST_QUEUE_READS": { "type": "integer", "example": 0 }, "REQUEST_QUEUE_WRITES": { "type": "integer", "example": 0 }, "DATA_TRANSFER_INTERNAL_GBYTES": { "type": "integer", "example": 0 }, "DATA_TRANSFER_EXTERNAL_GBYTES": { "type": "integer", "example": 0 }, "PROXY_RESIDENTIAL_TRANSFER_GBYTES": { "type": "integer", "example": 0 }, "PROXY_SERPS": { "type": "integer", "example": 0 } } } } } } } } } } ```