FDA MCP Server (OpenPharma)

Community MCP server that puts the FDA Orange Book (small-molecule patents and exclusivity) and Purple Book (biologics and biosimilars) in front of Claude alongside openFDA, so loss-of-exclusivity and biosimilar-interchangeability questions can be answered without hand-searching the FDA portals.

   
Type MCP server
Supplier OpenPharma
Availability Beta — package.json declares v1.0.0, but no npm package is published (both fda-mcp and @openpharma-org/fda-mcp-server return 404 on the registry as of 2026-08-09), so installation is from source. Repo last pushed 2026-03-10
Pricing Free / OSS (MIT, LICENSE in repo root). No API key required
Capabilities Read-only — queries public FDA datasets; downloads and caches Orange/Purple Book data locally
Verified works · 2026-08-10
Security cleared · 2026-08-10 — MIT, provenance matches OpenPharma, no OSV/GHSA advisories

How to install

There is no published package, so build from source. Requires Node.js ≥ 18.

git clone https://github.com/openpharma-org/fda-mcp
cd fda-mcp
npm install
npm run build

That produces build/index.js (the main and bin entry point declared in package.json).

  • Claude Code — register the built server over stdio:

    claude mcp add --transport stdio fda-mcp -- node /path/to/fda-mcp/build/index.js

    (replace /path/to/fda-mcp with the absolute path of your clone — e.g. /Users/you/repos/fda-mcp, or run pwd while still inside the directory from the previous step and paste that. The upstream README writes this path as /path/to/fda-mcp-server/…, which does not match the repository’s own directory name — use fda-mcp unless you renamed the clone.)

  • Claude Desktop — add to claude_desktop_config.json:

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

    (same absolute-path substitution; restart Claude Desktop after editing.)

  • Verify it starts (optional): node build/index.js from the clone should boot and wait on stdio. Ctrl-C once it does — Claude Code and Claude Desktop launch the process themselves, so this is not a service to leave running.

On first use the server downloads and caches the Orange Book and Purple Book datasets, so the initial query is slow; subsequent lookups hit the local cache.

What it does

Exposes a single tool, fda_info, dispatched by method:

  • lookup_drug — general drug lookup across openFDA search types
  • search_orange_book — brand and generic product search
  • get_therapeutic_equivalents — AB-rated generic alternatives for a product
  • get_patent_exclusivity — patents and exclusivity periods by NDA number
  • analyze_patent_cliff — generic-entry forecasting / loss-of-exclusivity analysis
  • search_purple_book — biological products and biosimilars
  • get_biosimilar_interchangeability — interchangeability designations

Upstream reports coverage of 47,486 Orange Book drug products, 21,126 patents, and 2,444 exclusivity periods, plus 2,168 Purple Book biological products, with openFDA fields for adverse events, labels, recalls, and shortages.

Primary use cases: loss-of-exclusivity timing for a portfolio, finding AB-rated substitutes, biosimilar and interchangeability status, patent-cliff analysis for competitive intelligence.

Notes

The distinguishing surface is Orange Book patent/exclusivity and Purple Book biosimilar interchangeability — neither is covered by the openFDA-only servers already catalogued. If you only need adverse events, labels, or recalls, OpenFDA MCP Server (cyanheads) installs in one command from npm and is more actively maintained.

Treat the patent-cliff output as a research aid, not a legal or commercial opinion: the Orange Book is the FDA’s listing of patents a sponsor chose to submit, and generic entry additionally depends on ANDA approval, exclusivity codes, litigation, and settlements that no dataset here captures. Cached data ages between refreshes — confirm any date you plan to act on against the live FDA portal.

The single-tool-with-methods design means the model has to pick the right method string; if a query returns nothing useful, name the method explicitly in the prompt.

Complements openFDA, FDA drug databases, DailyMed, and the Drug Regulatory Research skill, which reasons over the same Orange Book records through ToolUniverse.

Sources

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