Priori Patent Intelligence: Drug LOE Calendar

Turn the FDA Orange Book into a drug loss-of-exclusivity (LOE) calendar. Query any small-molecule drug or company and get every listed patent, the exclusivity windows, and a computed "latest listed protection" date, so you can see when a drug faces generic competition. Built on free, public FDA data, with every field cited back to the source record.

Part of the Priori Intelligence family of biotech and patent data tools.

What it does

Give it a drug name or a company name. It returns, per drug:

• Every Orange-Book-listed patent (number, expiry, whether it is a drug substance, drug product, or method-of-use patent, and whether a method-of-use patent may be carved out under section viii).
• Every FDA exclusivity (code, plain-English meaning, expiry).
• The latest listed protection date and the specific patent or exclusivity that controls it.
• A company LOE calendar: one cliff per drug, ordered by nearest upcoming loss of exclusivity.

Why use it

Commercial patent-cliff intelligence (DrugPatentWatch, Cortellis, Patsnap) is powerful but expensive and enterprise-gated. This tool gives you the core LOE signal per query, pay-as-you-go, callable by your AI agent, at a fraction of the price. It is built for biotech investors, patent attorneys and IP analysts, generic and biosimilar strategists, and due-diligence teams who need the answer on a handful of drugs, not an annual seat.

Input

Field	Type	Description
mode	string	drug (look up a drug by ingredient or brand) or company (roll up all of a company's drugs). Default drug.
query	string	The drug name (drug mode) or company/applicant name (company mode). Case-insensitive substring match. Required.
maxResults	integer	Cap on records returned in drug mode. Default 100.

Example:

{ "mode": "drug", "query": "apixaban" }

{ "mode": "company", "query": "bristol myers squibb" }

Output

Drug mode returns one record per matched product with its patents, exclusivities, latestListedProtection, controllingProtection, and an offPatent flag. Company mode returns a single calendar object with a deduped, date-ordered cliffs array plus the full per-product drugs detail. Every record carries a _citation block (source, source version, record id, retrieval timestamp, disclaimer). Export as JSON, CSV, or Excel.

Coverage and limitations

• Small molecules only. The Orange Book covers drugs approved under NDAs and ANDAs. Biologics (approved under BLAs) are not in the Orange Book; their exclusivity lives in the FDA Purple Book, which is planned as a companion tool.
• The computed date reflects the latest listed patent and exclusivity expirations only. It does not model Paragraph IV challenges, section viii method-of-use carve-outs, ongoing litigation, or settlement agreements, any of which can move actual generic entry earlier. Treat the output as a research starting point, not a legal opinion or a freedom-to-operate clearance.
• Source data is the FDA Orange Book monthly data files, refreshed monthly.

Data source

FDA Orange Book data files (https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files), a public U.S. government record in the public domain. This tool downloads the official monthly files, parses the products, patent, and exclusivity tables, and computes the LOE analysis. It is not affiliated with or endorsed by the FDA.

Roadmap

• Purple Book (biologics and biosimilar exclusivity) companion coverage.
• Scheduled monitoring mode with alerts on LOE changes.
• Dataset schema and Store views for cleaner tabular output.
• Cross-links to the Priori Patent Intelligence global patent-family tool.

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Developer notes

TypeScript Apify Actor. Local development:

npm install
npm run build        # tsc -> dist/
npm test             # unit tests (node:test via tsx)
# local run: put input in storage/key_value_stores/default/INPUT.json
ACTOR_TEST_PAY_PER_EVENT=true npm run dev

Structure:

• src/core/ portable Priori operational scaffold (conditional pay-per-event billing, source-citation stamping, completeness gate, monthly source cache). This is intended for extraction into a shared package when the second Priori Actor is built.
• src/loe/ LOE-specific logic (Orange Book download and parse, the LOE computation, and drug/company queries).
• src/main.ts Actor entry point.

Pay-per-event: custom events are charged only after a valid result is stored, so failed, empty, or incomplete runs charge nothing for drug-loe-record or company-loe-calendar. Configure the event prices in the Apify Console before publishing.