@pipeworx/fda-drug-competition

Connect: https://gateway.pipeworx.io/fda-drug-competition/mcp · Install: one-click buttons

Tools: 17

FDA drug-competition MCP for Orange Book small-molecule approvals, patents, and exclusivities plus Purple Book biologic and biosimilar licensure data.

Tools

  • orange_book_product_search(...) — search approved NDA and ANDA product rows by drug, applicant, or application.
  • orange_book_competition_profile(...) — profile NDA/ANDA applications, applicants, patents, and exclusivities for a drug.
  • orange_book_application_detail(...) — retrieve the products, patents, and exclusivities attached to one application.
  • orange_book_patent_expirations(...) — find listed patent expirations in a date window.
  • orange_book_exclusivity_expirations(...) — find regulatory-exclusivity expirations in a date window.
  • orange_book_loss_of_exclusivity_profile(...) — assemble reference applications, approved ANDAs, and active or elapsed patent/exclusivity ranges for LOE diligence.
  • orange_book_generic_entry_timeline(...) — show first approval timing for unique ANDA applications.
  • orange_book_reference_drug_landscape(...) — compare RLD/reference-standard designations and approved ANDAs by dosage form and route.
  • orange_book_expiry_cliff_calendar(...) — combine patent and exclusivity expirations into a drug-aware calendar.
  • purple_book_product_search(...) — search licensed biologic product rows by name, applicant, reference product, or BLA.
  • purple_book_competition_profile(...) — count reference, biosimilar, and interchangeable BLAs around a biologic.
  • purple_book_biosimilars(...) — list licensed 351(k) biosimilar and interchangeable products.
  • purple_book_interchangeables(...) — list products carrying FDA’s interchangeable designation.
  • purple_book_reference_product(...) — connect a reference biologic to related licensed 351(k) products.
  • purple_book_recent_changes(...) — read the additions and updates in FDA’s latest monthly report.
  • purple_book_biosimilar_entry_timeline(...) — show approval timing for unique 351(k) BLAs associated with a reference biologic.

Cross-source

  • drug_patent_challenge_profile(drug|application_no) — how exposed one brand’s exclusivity actually is: Orange Book patents and expiries, the PTAB proceedings filed against those exact patent numbers, and the ANDA / Hatch-Waxman dockets naming the brand, with the earliest expiry NOT under challenge and which generics are litigating. Joins what were three separate hand-run queries.

Gotchas this tool encodes

  • A brand spans several NDAs. Eliquis has two (202155, 220073). Patents hang off the NDA rows, so grouping by application is what keeps all of them.
  • 6967208*PED is not a second patent. It is the pediatric-exclusivity row for 6967208, carrying the 6-month-extended expiry. Reading it as distinct double-counted proceedings and inflated “patents under challenge” from 2 to 4. Normalised to the bare number; the extension survives as a flag and as the patent’s effective expiry.
  • Line extensions poison the docket search. Taking the first trade name gave “ELIQUIS SPRINKLE”; the shortest one is the brand a complaint is captioned under.
  • A PTAB search by patent number also returns reissue proceedings. Kept — a reissue challenge is real — but labelled against_reissue so it is not double-counted as the original.
  • No paragraph-IV flag is reported. The Orange Book ZIP has no such column. Challenge evidence is the PTAB and docket legs; inferring a P-IV listing from them would dress inference as an FDA record.

Each leg degrades independently: if PTAB or the docket search fails, the others return with partial: true and the reason, never a bare throw.

Auth

Keyless for every Orange Book and Purple Book tool.

drug_patent_challenge_profile additionally calls USPTO PTAB, which uses the platform USPTO key (injected as _usptoKey), and CourtListener. Without the key the tool still returns the Orange Book and docket legs and reports the PTAB leg as unavailable.

Freshness — what an answer tells you about its own age

FDA republishes the Orange Book bulk ZIP once a month at a fixed URL (fda.gov/media/76860/download, EOBZIP_YYYY_MM.zip). Every response therefore carries:

  • dataset_updated — the file’s last-modified, i.e. which edition answered.
  • dataset_age_days — how old that edition is today.
  • dataset_stale + dataset_note — present only when the snapshot is past one publication cycle (45 days) or when fda.gov refused a refresh, so the answer reflects the last edition retrieved rather than a live check. The note says so in a sentence, because a bare timestamp is not something a model weighs against a confident-looking list of expiry dates.

A monthly file is not re-read per call, and a refused refresh is covered for up to 45 days, always flagged. Past 45 days the pack fails instead of answering: a lapsed exclusivity still reads as live in an old snapshot, and for this data a visible failure beats a confident wrong date.

www.fda.gov is behind Akamai bot management, which refuses some Cloudflare egress with a generic 404 — Not found. That is not a moved file; do not chase the URL when you see it (fleet #1127, docs/bulk-download-freshness-exposure.md).

Data sources

Orange Book patent dates are sponsor-submitted listings, and regulatory approval dates do not establish launch, availability, sales, market share, patent enforceability, or a certain generic-entry date. RLD and reference-standard designations serve different FDA purposes. Purple Book interchangeability is an FDA designation; pharmacy substitution remains subject to applicable law and circumstances.

Tools

  • 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
  • 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 indicat
  • 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
  • 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 (“X
  • 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 dr
  • 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-exclusiv
  • 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 co
  • 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 a
  • 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-
  • 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 da
  • 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 laun
  • 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 interc
  • 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 avail
  • 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 r
  • 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 interchange

Tools

  • 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 da
  • 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
  • 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 indicat
  • 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 dr
  • 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-
  • 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 co
  • 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-exclusiv
  • 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 ( X
  • 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
  • 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 a
  • 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 interchange
  • 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 avail
  • 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 interc
  • 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 r
  • 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 laun
  • 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_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.

Regenerated from source · build September 10, 2026