FDA

You have access to a capable MCP server that combines FDA data, Orange Book, Purple Book, and up-to-date regulatory intelligence to deliver fast, actionable pharmaceutical insights. This server enables you to run complex lookups, track patent cliffs and exclusivity, identify AB-rated generics, and monitor biosimilars and regulatory events all from a single interface.

How to use

You interact with the FDA MCP Server through a compatible MCP client. Start by launching the server locally or connecting to a remote MCP endpoint, then issue structured requests to perform drug data lookups, orange/purple book searches, patent and exclusivity analyses, and biosimilar checks. You can combine general searches with focused field queries to retrieve precise data, such as TE codes, patent expiration dates, and interchangeability status.

Typical workflows include: discovering AB-rated generics for a brand-name drug, forecasting generic entry dates, mapping biosimilars to reference products, and retrieving safety data like adverse events, recalls, and shortages. You can also query for regulatory actions such as FDA approvals, recalls, and shortages to inform risk assessments and market analyses.

How to install

Prerequisites: you need Node.js installed on your system to run the MCP server locally.

1. Prepare a local directory for the MCP server. 2) Place the MCP server entry point and build outputs in your working path. 3) Start the MCP server using the provided command snippet.

Use the following explicit MCP configuration example to connect your client to the server. It runs the server locally through Node.js and points to the built entry file.

Configuration and run configuration

The server is designed to be invoked by an MCP client through a standard runtime command. The example below shows how to configure a local STDIO-based MCP server instance that runs via Node and loads the built index. This configuration is self-contained and ready to use after you have built the server.

{
  "mcpServers": {
    "fda_mcp": {
      "command": "node",
      "args": ["/path/to/fda-mcp-server/build/index.js"],
      "env": {}
    }
  }
}

Tool endpoints and available features

The server exposes a unified tool for FDA drug information lookup and related pharmaceutical intelligence. This tool provides operations to look up drugs, search Orange Book and Purple Book data, retrieve patent and exclusivity information, and analyze patent cliffs.

Primary capability name: fda_info.

Real-world capabilities you can leverage

Orange Book integration provides TE codes, patent and exclusivity data, and detailed patent timelines. Purple Book integration delivers biosimilar search results, reference product mappings, and interchangeability designations. OpenFDA queries enable comprehensive drug information lookups, adverse event safety data, recalls, and shortages. You gain fast query performance after initial setup and automatic monthly data updates.

Usage tips

Keep your data current: the server automatically downloads monthly updates to keep Orange Book and Purple Book data fresh. Use field-targeted searches to retrieve precise data (for example, TE codes, marketing status, or patent expiration dates). When analyzing patent cliffs, specify the drug name and how far ahead you want to forecast to obtain LOE timelines and expected generic entry.

Available tools

fda_info

Unified tool for FDA drug information lookup, safety data, and pharmaceutical intelligence.

search_orange_book

Query Orange Book data for patents, exclusivity, TE codes, and therapeutic equivalents.

get_patent_exclusivity

Retrieve patent and exclusivity data by NDA number.

analyze_patent_cliff

Analyze when a drug will lose patent or exclusivity protection and forecast generic entry.

search_purple_book

Search Purple Book data for biosimilars and interchangeability designations.

get_biosimilar_interchangeability

Check which biosimilars are interchangeable with a reference product.