MCP server exposing 17 tools for fda-drug-competition.
This URL is a JSON-RPC 2.0 endpoint over HTTP. Issue POST requests with a JSON-RPC body. Browsers and search crawlers land here on GET.
POST https://gateway.pipeworx.io/fda-drug-competition/mcp
Content-Type: application/json
{"jsonrpc":"2.0","id":1,"method":"tools/list"}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 — 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 actually want a window, and anything the window excludes is counted and dated back to you so a filtered view is never mistaken for the full picture. Covers small-molecule drugs; biologics are in the Purple Book. Dates are sponsor-submitted FDA listings and do not establish freedom to operate or a certain launch date.orange_book_exclusivity_expirations — 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 excluded is counted and dated back to you. Exclusivity codes have program-specific meanings; expiration alone does not guarantee generic approval or launch.orange_book_loss_of_exclusivity_profile — 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_generic_entry_timeline — 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_reference_drug_landscape — 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.orange_book_expiry_cliff_calendar — 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.drug_patent_challenge_profile — 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 / Hatch-Waxman district-court dockets naming the brand. Returns the earliest expiry NOT under challenge, which patents are actively contested, and which generic firms are litigating. Use for loss-of-exclusivity diligence, generic-entry timing, or "who is attacking this drug and where". Listed dates are FDA/USPTO/court records, not a legal conclusion about enforceability or actual launch.purple_book_product_search — 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_competition_profile — 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_biosimilars — 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_interchangeables — 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_reference_product — 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.purple_book_recent_changes — 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_biosimilar_entry_timeline — 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.Code samples (curl / TypeScript / one-click client install), schemas, and the live playground are on the pack page:
https://pipeworx.io/packs/fda-drug-competition/
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