MCP server

Fda Drug Competition

io.github.pipeworx-io/fda-drug-competition

Checked 26 Oct 2026, 08:29 UTC · Connected to it and listed its tools

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

Website Source

At a glance

Type

MCP server

Publisher

pipeworx.io (verified by the MCP Registry)

Status

Working at last check

Tools

59

Token cost

About 29,864 tokens per request

Sets up in

Claude Code, Claude Desktop, Codex, Gemini CLI, Cursor, VS Code, Antigravity, ChatGPT, OpenAI API, Grok

Last checked

26 Oct 2026, 08:29 UTC

Connect it to your agent

Add to CursorAdd to VS CodeVS Code Insiders

Opens the app, which shows the server and asks you to confirm. For other apps, copy the setup below.

Claude Code

claude mcp add --transport http fda-drug-competition https://gateway.pipeworx.io/fda-drug-competition/mcp

Claude Desktop

Settings → Connectors → Add custom connector, and paste the URL.

Codex (config.toml)

[mcp_servers.fda-drug-competition]
url = "https://gateway.pipeworx.io/fda-drug-competition/mcp"

Gemini CLI

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

Cursor

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

VS Code

{"servers":{"fda-drug-competition":{"type":"http","url":"https://gateway.pipeworx.io/fda-drug-competition/mcp"}}}

Antigravity

agy mcp add fda-drug-competition https://gateway.pipeworx.io/fda-drug-competition/mcp

ChatGPT

Settings → Apps & Connectors → Advanced settings: turn on Developer mode, then Create a connector and paste the URL. Which plans can do this varies.

OpenAI API (Responses tools)

{"type":"mcp","server_label":"fda-drug-competition","server_url":"https://gateway.pipeworx.io/fda-drug-competition/mcp","require_approval":"always"}

Grok (xAI API tools)

{"type":"mcp","server_label":"fda-drug-competition","server_url":"https://gateway.pipeworx.io/fda-drug-competition/mcp"}

Tools

• drug_patent_challenge_profile ~396 tokens
  How exposed is one brand drug's patent protection, in a single call. Joins the three sources a generics or biotech analyst otherwise queries by hand: FDA Orange Book listed patents and their expiry dates, USPTO PTAB proceedings (IPR/PGR) filed against those exact patent numbers, and federal ANDA / H
• orange_book_application_detail ~143 tokens
  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_competition_profile ~168 tokens
  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_exclusivity_expirations ~313 tokens
  When does FDA marketing exclusivity expire for a drug — the listed Orange Book exclusivity expiration dates for a brand or ingredient, with the earliest and latest across the whole schedule. Ask by drug alone to get everything on file; add from_date/to_date only when you want a window, and anything
• orange_book_expiry_cliff_calendar ~216 tokens
  Create a combined calendar of FDA Orange Book patent and regulatory-exclusivity expirations. Returns dated events with ingredient, trade name, applicant, application, patent/use-code, and exclusivity-code context for cliff monitoring.
• orange_book_generic_entry_timeline ~190 tokens
  Chronologically summarize FDA-approved ANDA applications matching an ingredient or trade name, deduplicated across strengths and products. Returns first approval dates, applicants, dosage forms, TE codes, and active-product counts for generic-entry analysis.
• orange_book_loss_of_exclusivity_profile ~203 tokens
  Build an FDA Orange Book loss-of-exclusivity evidence profile for a drug. Returns reference applications, approved ANDA counts and timing, plus active and elapsed listed patent and regulatory-exclusivity date ranges for LOE diligence.
• orange_book_patent_expirations ~370 tokens
  When do the patents on a drug expire — the listed Orange Book patent expiration dates for a brand or ingredient, in order, with the earliest and latest across the whole schedule. Ask by drug alone ("Xarelto", "semaglutide") to get its full expiry schedule; add from_date/to_date only when you actuall
• orange_book_product_search ~203 tokens
  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_reference_drug_landscape ~177 tokens
  Map FDA Orange Book reference listed drugs and reference standards to approved ANDA competition by dosage-form/route and therapeutic-equivalence code. Returns reference applications, ANDA counts and applicants, and TE-code groupings.
• purple_book_biosimilar_entry_timeline ~181 tokens
  Chronologically summarize unique FDA-licensed 351(k) BLAs associated with a reference biologic. Returns approval dates, applicants, product names, reference products, and biosimilar versus interchangeable designations for entry analysis.
• purple_book_biosimilars ~166 tokens
  List FDA-licensed 351(k) biosimilar and interchangeable products for an optional reference product, applicant, or product name. Approval/licensure does not establish commercial launch or current availability.
• purple_book_competition_profile ~161 tokens
  Profile FDA-licensed biologic competition around a proper, proprietary, or reference-product name. Counts unique BLAs as sponsors/applications and separates reference products, biosimilars, and interchangeables. It does not measure launches, availability, sales, or market share.
• purple_book_interchangeables ~129 tokens
  List FDA Purple Book products designated 351(k) Interchangeable, optionally filtered by reference product, applicant, or product name. Interchangeability is an FDA designation; pharmacy substitution remains subject to applicable law and circumstances.
• purple_book_product_search ~290 tokens
  Search FDA Purple Book biologic products by proper/proprietary name, applicant, reference product, or BLA. Returns licensure and product-level attributes. A licensed biosimilar is not necessarily launched, available, interchangeable, or substitutable under state law. Purple Book covers ONLY licensed
• purple_book_recent_changes ~125 tokens
  Return the changes section of FDA’s latest monthly Purple Book report: N=newly approved, R=added in current release, U=updated. Updated or added does not necessarily mean newly licensed.
• purple_book_reference_product ~130 tokens
  Find a reference biologic and its FDA-licensed 351(k) products by proper or proprietary name. Product rows and BLA counts must not be interpreted as market participants, launches, or market share.

Browse

• GitHub tools
• Calendars
• Hiring and jobs
• Legal research
• GitHub and code hosting

Related MCP servers

• SiteCheck Health & Travel
  121 pay-per-call agent tools: health care, drug, provider and travel data tools. x402
• Loe Exposure
  Drug patent expiries ranked by the Medicare Part D spending exposed to them
• Veterinary Fda
  Veterinary FDA MCP — openFDA Animal & Veterinary adverse events, pet/animal
• Generic Timeline
  Whether a drug has a marketed generic today, and when its Orange Book protections lapse
• Prognyx oncology intelligence
  Live ClinicalTrials.gov oncology trial comparison around an asset, plus landscapes and CI briefings.
• CounterScript - Drug Price Benchmarks
  Free US drug-price benchmarks from federal data (CMS NADAC): a benchmark, not a price anyone owes.
• Medicaid Intelligence
  MCP server for medicaid-intelligence
• Nexscope
  Ecommerce data MCP: Amazon, TikTok Shop, Walmart, Temu, Ozon, Shopee, 1688, Etsy, eBay & more

Badge for your README

[![AptLynx](https://aptlynx.net/badge/io.github.pipeworx-io/fda-drug-competition.svg)](https://aptlynx.net/servers/io.github.pipeworx-io/fda-drug-competition)

Listing text is written by the maker; AptLynx lists tools and does not vouch for them. Find another tool · Browse by topic · For agents