Fda Drug Competition
live HealthBooksOrange Book competitive intelligence from FDA's monthly official data ZIP.
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
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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
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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
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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
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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
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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
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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
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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
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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-
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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
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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
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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
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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
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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
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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.
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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.
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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
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Test with curl
The gateway speaks JSON-RPC 2.0 over HTTP POST. You can test any pack directly from the terminal.
curl -X POST https://gateway.pipeworx.io/fda-drug-competition/mcp \
-H "Content-Type: application/json" \
-d '{"jsonrpc":"2.0","id":1,"method":"tools/list"}'curl -X POST https://gateway.pipeworx.io/fda-drug-competition/mcp \
-H "Content-Type: application/json" \
-d '{"jsonrpc":"2.0","id":2,"method":"tools/call","params":{"name":"orange_book_product_search","arguments":{}}}'Use with the SDK
Install @pipeworx/sdk to call tools from any TypeScript/Node project.
import { Pipeworx } from '@pipeworx/sdk';
const px = new Pipeworx();
const result = await px.call("orange_book_product_search", {});// Or ask in plain English:
const answer = await px.ask("orange book competitive intelligence from fda's monthly official data zip");