# FDA Orange Book Patent Expirations Monitor (`oobr/fda-orange-book-patent-expirations`) Actor Monthly Orange Book extracts with patent expiration dates, applicant, active ingredient — for generics timing & IP diligence. - **URL**: https://apify.com/oobr/fda-orange-book-patent-expirations.md - **Developed by:** [OOBR Team](https://apify.com/oobr) (community) - **Categories:** Lead generation, MCP servers - **Stats:** 1 total users, 0 monthly users, 0.0% runs succeeded, NaN bookmarks - **User rating**: No ratings yet ## Pricing from $50.00 / 1,000 fda orange book patent 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 a software tools running on the Apify platform, for all kinds of web data extraction and automation use cases. 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.md): ```bash npm install apify-client ``` In Python projects, use official [Python client library](https://docs.apify.com/api/client/python.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/platform/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 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 ```json { "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](https://www.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-equivalence-evaluations-orange-book). The canonical download redirect is [`https://www.fda.gov/media/76860/download`](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. # Actor input Schema ## `applicantFilter` (type: `string`): Return only rows whose applicant name contains this substring. Blank = all applicants. ## `activeIngredientFilter` (type: `string`): Return only rows whose active ingredient contains this substring. Blank = all ingredients. ## `expireAfter` (type: `string`): ISO date. Blank = no lower bound. ## `expireBefore` (type: `string`): ISO date. Blank = no upper bound. ## `maxResults` (type: `integer`): Hard cap on rows emitted. The unfiltered Orange Book patent table is roughly 12–14k rows — cap defaults to 500 for a representative first run. ## `includeDelisted` (type: `boolean`): If true, also emit rows where delist\_flag = 'Y'. Default false. ## Actor input object example ```json { "applicantFilter": "", "activeIngredientFilter": "", "expireAfter": "", "expireBefore": "", "maxResults": 500, "includeDelisted": 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 = {}; // Run the Actor and wait for it to finish const run = await client.actor("oobr/fda-orange-book-patent-expirations").call(input); // Fetch and print Actor results from the run's dataset (if any) console.log('Results from dataset'); console.log(`💾 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); }); // 📚 Want to learn more 📖? Go to → 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 = {} # Run the Actor and wait for it to finish run = client.actor("oobr/fda-orange-book-patent-expirations").call(run_input=run_input) # Fetch and print Actor results from the run's dataset (if there are any) print("💾 Check your data here: https://console.apify.com/storage/datasets/" + run["defaultDatasetId"]) for item in client.dataset(run["defaultDatasetId"]).iterate_items(): print(item) # 📚 Want to learn more 📖? Go to → https://docs.apify.com/api/client/python/docs/quick-start ``` ## CLI example ```bash echo '{}' | apify call oobr/fda-orange-book-patent-expirations --silent --output-dataset ``` ## MCP server setup ```json { "mcpServers": { "apify": { "command": "npx", "args": [ "mcp-remote", "https://mcp.apify.com/?tools=oobr/fda-orange-book-patent-expirations", "--header", "Authorization: Bearer " ] } } } ``` ## OpenAPI specification ```json { "openapi": "3.0.1", "info": { "title": "FDA Orange Book Patent Expirations Monitor", "description": "Monthly Orange Book extracts with patent expiration dates, applicant, active ingredient — for generics timing & IP diligence.", "version": "0.0", "x-build-id": "PBhJwok6UtTUwCZrm" }, "servers": [ { "url": "https://api.apify.com/v2" } ], "paths": { "/acts/oobr~fda-orange-book-patent-expirations/run-sync-get-dataset-items": { "post": { "operationId": "run-sync-get-dataset-items-oobr-fda-orange-book-patent-expirations", "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": { "$ref": "#/components/schemas/inputSchema" } } } }, "parameters": [ { "name": "token", "in": "query", "required": true, "schema": { "type": "string" }, "description": "Enter your Apify token here" } ], "responses": { "200": { "description": "OK" } } } }, "/acts/oobr~fda-orange-book-patent-expirations/runs": { "post": { "operationId": "runs-sync-oobr-fda-orange-book-patent-expirations", "x-openai-isConsequential": false, "summary": "Executes an Actor and returns information about the initiated run in response.", "tags": [ "Run Actor" ], "requestBody": { "required": true, "content": { "application/json": { "schema": { "$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": { "$ref": "#/components/schemas/runsResponseSchema" } } } } } } }, "/acts/oobr~fda-orange-book-patent-expirations/run-sync": { "post": { "operationId": "run-sync-oobr-fda-orange-book-patent-expirations", "x-openai-isConsequential": false, "summary": "Executes an Actor, waits for completion, and returns the OUTPUT from Key-value store in response.", "tags": [ "Run Actor" ], "requestBody": { "required": true, "content": { "application/json": { "schema": { "$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", "properties": { "applicantFilter": { "title": "Applicant filter (substring, case-insensitive)", "type": "string", "description": "Return only rows whose applicant name contains this substring. Blank = all applicants.", "default": "" }, "activeIngredientFilter": { "title": "Active ingredient filter (substring, case-insensitive)", "type": "string", "description": "Return only rows whose active ingredient contains this substring. Blank = all ingredients.", "default": "" }, "expireAfter": { "title": "Only patents expiring on or after (YYYY-MM-DD)", "type": "string", "description": "ISO date. Blank = no lower bound.", "default": "" }, "expireBefore": { "title": "Only patents expiring on or before (YYYY-MM-DD)", "type": "string", "description": "ISO date. Blank = no upper bound.", "default": "" }, "maxResults": { "title": "Max results", "minimum": 1, "maximum": 50000, "type": "integer", "description": "Hard cap on rows emitted. The unfiltered Orange Book patent table is roughly 12–14k rows — cap defaults to 500 for a representative first run.", "default": 500 }, "includeDelisted": { "title": "Include delisted patents", "type": "boolean", "description": "If true, also emit rows where delist_flag = 'Y'. Default false.", "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 } } } } } } } } } } ```