This MCP server provides Orange Book competitive intelligence sourced from FDA’s monthly official data ZIP. It exposes tools for searching Orange Book products and generating competition profiles, including key regulatory fields such as NDA/ANDA status, therapeutic-equivalence codes, RLD/reference-standard flags, strength, route, and approval dates.

🛠️ Key Features

Orange Book competitive intelligence from FDA’s monthly official data ZIP
Topics: mcp, mcp-server, model-context-protocol, pipeworx, fda-drug-competition
Tools:
- orange_book_product_search
- orange_book_competition_profile

🚀 Use Cases

Search FDA Orange Book products by ingredient, trade name, applicant, or application number
Retrieve competition-related information by producing an FDA Orange Book competition profile

⚡ Developer Benefits

Structured tool outputs for Orange Book data, including NDA/ANDA status and therapeutic-equivalence codes
Supports RLD/reference-standard flags plus strength, route, and approval date

⚠️ Limitations

Described scope is limited to FDA Orange Book intelligence from the monthly official data ZIP
Tool details beyond the provided tool names and the partial orange_book_competition_profile description are not included

mcp-fda-drug-competition

Orange Book competitive intelligence from FDA's monthly official data ZIP.

Part of Pipeworx — an MCP gateway connecting AI agents to 1361+ live data sources.

Tools

Tool	Description
`orange_book_product_search`	Search FDA Orange Book products by ingredient, trade name, applicant, or application number. Returns NDA/ANDA status, therapeutic-equivalence codes, RLD/reference-standard flags, strength, route, and approval date.
`orange_book_competition_profile`	Profile FDA Orange Book competition for an ingredient or trade name: matched applications/products, NDA versus ANDA holders, RLD/reference standards, patents, and exclusivities. Approved ANDAs indicate regulatory approval, not launch, supply, substitution, or market share.
`orange_book_application_detail`	Retrieve all FDA Orange Book product, patent, and exclusivity rows for one NDA or ANDA application. Patent and exclusivity dates are FDA listings, not a legal conclusion about enforceability or actual generic entry.
`orange_book_patent_expirations`	Find listed Orange Book patent expirations in a date window, optionally filtered by drug/applicant through matching product applications. Dates are sponsor-submitted FDA listings and do not establish freedom to operate or a certain launch date.
`orange_book_exclusivity_expirations`	Find FDA Orange Book exclusivity expirations in a date window, optionally filtered by drug/applicant. Exclusivity codes have program-specific meanings; expiration alone does not guarantee generic approval or launch.

Quick Start

Add to your MCP client (Claude Desktop, Cursor, Windsurf, etc.):

json

{
  "mcpServers": {
    "fda-drug-competition": {
      "url": "https://gateway.pipeworx.io/fda-drug-competition/mcp"
    }
  }
}

Or connect to the full Pipeworx gateway for access to all 1361+ data sources:

json

{
  "mcpServers": {
    "pipeworx": {
      "url": "https://gateway.pipeworx.io/mcp"
    }
  }
}

Using with ask_pipeworx

Instead of calling tools directly, you can ask questions in plain English:

code

ask_pipeworx({ question: "your question about Fda Drug Competition data" })

The gateway picks the right tool and fills the arguments automatically.

License

MIT

Fda Drug Competition

🛠️ Key Features

🚀 Use Cases

⚡ Developer Benefits

⚠️ Limitations

Topics

mcp-fda-drug-competition

Tools

Quick Start

Using with ask_pipeworx

More

License

Install

Remote endpoint