# Priori Drug Patent Loss-of-Exclusivity (LOE) Calendar (`priori_intelligence/priori-drug-loss-of-exclusivity-calendar`) Actor FDA Orange Book drug patent and exclusivity intelligence: latest patent expiry, exclusivity windows, and a computed loss-of-exclusivity date by drug or company. - **URL**: https://apify.com/priori\_intelligence/priori-drug-loss-of-exclusivity-calendar.md - **Developed by:** [Greg Newkirk](https://apify.com/priori_intelligence) (community) - **Categories:** Developer tools, AI - **Stats:** 2 total users, 1 monthly users, 100.0% runs succeeded, 0 bookmarks - **User rating**: No ratings yet ## Pricing from $50.00 / 1,000 drug loss-of-exclusivity 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 ## Priori Patent Intelligence: Drug LOE Calendar Turn the FDA Orange Book into a drug **loss-of-exclusivity (LOE) calendar**. Query any small-molecule drug or company and get every listed patent, the exclusivity windows, and a computed "latest listed protection" date, so you can see when a drug faces generic competition. Built on free, public FDA data, with every field cited back to the source record. Part of the **Priori Intelligence** family of biotech and patent data tools. ### What it does Give it a drug name or a company name. It returns, per drug: - Every Orange-Book-listed **patent** (number, expiry, whether it is a drug substance, drug product, or method-of-use patent, and whether a method-of-use patent may be carved out under section viii). - Every FDA **exclusivity** (code, plain-English meaning, expiry). - The **latest listed protection** date and the specific patent or exclusivity that controls it. - A company **LOE calendar**: one cliff per drug, ordered by nearest upcoming loss of exclusivity. ### Why use it Commercial patent-cliff intelligence (DrugPatentWatch, Cortellis, Patsnap) is powerful but expensive and enterprise-gated. This tool gives you the core LOE signal per query, pay-as-you-go, callable by your AI agent, at a fraction of the price. It is built for biotech investors, patent attorneys and IP analysts, generic and biosimilar strategists, and due-diligence teams who need the answer on a handful of drugs, not an annual seat. ### Input | Field | Type | Description | |---|---|---| | `mode` | string | `drug` (look up a drug by ingredient or brand) or `company` (roll up all of a company's drugs). Default `drug`. | | `query` | string | The drug name (drug mode) or company/applicant name (company mode). Case-insensitive substring match. Required. | | `maxResults` | integer | Cap on records returned in drug mode. Default 100. | Example: ```json { "mode": "drug", "query": "apixaban" } ```` ```json { "mode": "company", "query": "bristol myers squibb" } ``` ### Output Drug mode returns one record per matched product with its patents, exclusivities, `latestListedProtection`, `controllingProtection`, and an `offPatent` flag. Company mode returns a single calendar object with a deduped, date-ordered `cliffs` array plus the full per-product `drugs` detail. Every record carries a `_citation` block (source, source version, record id, retrieval timestamp, disclaimer). Export as JSON, CSV, or Excel. ### Coverage and limitations - **Small molecules only.** The Orange Book covers drugs approved under NDAs and ANDAs. Biologics (approved under BLAs) are not in the Orange Book; their exclusivity lives in the FDA Purple Book, which is planned as a companion tool. - The computed date reflects the **latest listed patent and exclusivity expirations only**. It does not model Paragraph IV challenges, section viii method-of-use carve-outs, ongoing litigation, or settlement agreements, any of which can move actual generic entry earlier. Treat the output as a research starting point, not a legal opinion or a freedom-to-operate clearance. - Source data is the FDA Orange Book monthly data files, refreshed monthly. ### Data source FDA Orange Book data files (`https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files`), a public U.S. government record in the public domain. This tool downloads the official monthly files, parses the `products`, `patent`, and `exclusivity` tables, and computes the LOE analysis. It is not affiliated with or endorsed by the FDA. ### Roadmap - Purple Book (biologics and biosimilar exclusivity) companion coverage. - Scheduled monitoring mode with alerts on LOE changes. - Dataset schema and Store views for cleaner tabular output. - Cross-links to the Priori Patent Intelligence global patent-family tool. *** ### Developer notes TypeScript Apify Actor. Local development: ```bash npm install npm run build # tsc -> dist/ npm test # unit tests (node:test via tsx) ## local run: put input in storage/key_value_stores/default/INPUT.json ACTOR_TEST_PAY_PER_EVENT=true npm run dev ``` Structure: - `src/core/` portable Priori operational scaffold (conditional pay-per-event billing, source-citation stamping, completeness gate, monthly source cache). This is intended for extraction into a shared package when the second Priori Actor is built. - `src/loe/` LOE-specific logic (Orange Book download and parse, the LOE computation, and drug/company queries). - `src/main.ts` Actor entry point. Pay-per-event: custom events are charged only after a valid result is stored, so failed, empty, or incomplete runs charge nothing for `drug-loe-record` or `company-loe-calendar`. Configure the event prices in the Apify Console before publishing. # Actor input Schema ## `mode` (type: `string`): Look up a single drug (by ingredient or brand name) or roll up all drugs for a company/applicant. ## `query` (type: `string`): Drug ingredient or brand name (mode = drug), or company/applicant name (mode = company). Case-insensitive substring match. ## `maxResults` (type: `integer`): Cap on the number of drug records returned in drug mode. ## Actor input object example ```json { "mode": "drug", "query": "apixaban", "maxResults": 100 } ``` # 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 = { "mode": "drug", "query": "apixaban" }; // Run the Actor and wait for it to finish const run = await client.actor("priori_intelligence/priori-drug-loss-of-exclusivity-calendar").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 = { "mode": "drug", "query": "apixaban", } # Run the Actor and wait for it to finish run = client.actor("priori_intelligence/priori-drug-loss-of-exclusivity-calendar").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 '{ "mode": "drug", "query": "apixaban" }' | apify call priori_intelligence/priori-drug-loss-of-exclusivity-calendar --silent --output-dataset ``` ## MCP server setup ```json { "mcpServers": { "apify": { "command": "npx", "args": [ "mcp-remote", "https://mcp.apify.com/?tools=priori_intelligence/priori-drug-loss-of-exclusivity-calendar", "--header", "Authorization: Bearer " ] } } } ``` ## OpenAPI specification ```json { "openapi": "3.0.1", "info": { "title": "Priori Drug Patent Loss-of-Exclusivity (LOE) Calendar", "description": "FDA Orange Book drug patent and exclusivity intelligence: latest patent expiry, exclusivity windows, and a computed loss-of-exclusivity date by drug or company.", "version": "0.1", "x-build-id": "r3L7tVrx8WdONjrRa" }, "servers": [ { "url": "https://api.apify.com/v2" } ], "paths": { "/acts/priori_intelligence~priori-drug-loss-of-exclusivity-calendar/run-sync-get-dataset-items": { "post": { "operationId": "run-sync-get-dataset-items-priori_intelligence-priori-drug-loss-of-exclusivity-calendar", "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": { "$ref": "#/components/schemas/inputSchema" } } } }, "parameters": [ { "name": "token", "in": "query", "required": true, "schema": { "type": "string" }, "description": "Enter your Apify token here" } ], "responses": { "200": { "description": "OK" } } } }, "/acts/priori_intelligence~priori-drug-loss-of-exclusivity-calendar/runs": { "post": { "operationId": "runs-sync-priori_intelligence-priori-drug-loss-of-exclusivity-calendar", "x-openai-isConsequential": false, "summary": "Executes an Actor and returns information about the initiated run in response.", "tags": [ "Run Actor" ], "requestBody": { "required": true, "content": { "application/json": { "schema": { "$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": { "$ref": "#/components/schemas/runsResponseSchema" } } } } } } }, "/acts/priori_intelligence~priori-drug-loss-of-exclusivity-calendar/run-sync": { "post": { "operationId": "run-sync-priori_intelligence-priori-drug-loss-of-exclusivity-calendar", "x-openai-isConsequential": false, "summary": "Executes an Actor, waits for completion, and returns the OUTPUT from Key-value store in response.", "tags": [ "Run Actor" ], "requestBody": { "required": true, "content": { "application/json": { "schema": { "$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": [ "query" ], "properties": { "mode": { "title": "Query mode", "enum": [ "drug", "company" ], "type": "string", "description": "Look up a single drug (by ingredient or brand name) or roll up all drugs for a company/applicant.", "default": "drug" }, "query": { "title": "Search term", "type": "string", "description": "Drug ingredient or brand name (mode = drug), or company/applicant name (mode = company). Case-insensitive substring match." }, "maxResults": { "title": "Max drug records", "minimum": 1, "maximum": 5000, "type": "integer", "description": "Cap on the number of drug records returned in drug mode.", "default": 100 } } }, "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 } } } } } } } } } } ```