{
  "name": "fda-drug-approvals-reference-mcp",
  "title": "HealthMesh · FDA Orange Book & Purple Book Reference MCP",
  "version": "0.1.2",
  "description": "FDA approved-drug reference data: the Orange Book (approved small-molecule drug products with therapeutic equivalence (TE) codes, RLD/RS flags, approval dates, marketing status, listed patents with use-code definitions and exclusivities) and the Purple Book (licensed biological products: 351(a) originators, 351(k) biosimilars and interchangeables, reference products, exclusivity dates). Bundled from FDA's monthly public data files.",
  "healthmesh_domain": "Pharmacy & PBM",
  "datasets": [
    "RX-08",
    "RX-09"
  ],
  "mcp_endpoint": "https://fda-drug-approvals-reference.healthmesh.ai/mcp",
  "transport": "Streamable HTTP (stateless, JSON responses)",
  "authorization": "none",
  "auth_mode": "off",
  "docs": "https://github.com/HendrikK/healthmesh/tree/main/servers/fda-drug-approvals-reference-mcp#readme",
  "contact": "hendrik.kleine@gmail.com",
  "data_source": {
    "name": "FDA Orange Book data files + Purple Book monthly data download",
    "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files",
    "license": "U.S. Government work, public domain",
    "refresh": "monthly (bundled; GitHub Actions checks FDA monthly)"
  },
  "tools": [
    {
      "name": "orangebook_search_products",
      "title": "Search Orange Book drug products",
      "description": "Searches FDA Orange Book approved drug products (NDAs and ANDAs, including discontinued ones) by free text over ingredient, trade name and applicant, or by ingredient / trade name / applicant / application number, with optional filters for application type, TE code and marketing status (RX, OTC, DISCN). Returns TE code, RLD/RS flags, approval date, strength and dosage form/route per product. For 'is there a generic?' questions use orangebook_find_equivalents."
    },
    {
      "name": "orangebook_find_equivalents",
      "title": "Find generics / therapeutic equivalents",
      "description": "Answers 'is there an approved generic for X?': for a brand (trade name) or application number, groups the reference products by ingredient + dosage form/route + strength and lists every other Orange Book product with the same ingredient, dosage form/route and strength (ANDA generics and other NDAs, e.g. 505(b)(2)), with TE codes, whether each is A-rated equivalent to the reference and whether it is marketed or discontinued. Authorized generics (sold under the brand's own NDA; FDA keeps a separate list) and tentative approvals are outside the Orange Book's scope and are not listed."
    },
    {
      "name": "orangebook_get_patents_exclusivity",
      "title": "Orange Book patents and exclusivities",
      "description": "Returns the patents (number, expiry date, drug substance / drug product flags, patent use code with FDA's definition, delist flag, pediatric-exclusivity extension) and FDA exclusivities (code with FDA's definition, expiry date) listed in the Orange Book for an application (NDA/ANDA number) or a brand name, grouped across products, plus the latest listed patent, exclusivity and overall protection dates."
    },
    {
      "name": "purplebook_search_biologics",
      "title": "Search Purple Book licensed biologics",
      "description": "Searches FDA Purple Book licensed biological products (CDER and CBER) by proprietary or proper name, BLA number, applicant or reference product, e.g. all biosimilars of Humira/adalimumab. Results are grouped per BLA: license type (351(a) originator, 351(k) biosimilar, 351(k) interchangeable), reference product, approval and interchangeability dates, licensure and marketing status, exclusivity expiry dates and product (strength/presentation) count."
    },
    {
      "name": "fda_reference_describe_dataset",
      "title": "Describe the Orange Book / Purple Book data",
      "description": "Explains the bundled FDA Orange Book and Purple Book data: file dates, row counts, SHA-256, field meanings (TE codes, RLD/RS, marketing status, patent flags, exclusivity codes, 351(a)/351(k) license types) and caveats."
    }
  ]
}