Approved Drug Products with Therapeutic Equivalence Evaluations is the authoritative record of approved drugs and their patent and exclusivity information. It is also current-state only, overwritten daily, and split across a dozen PDFs and static lists. Orange-Book.ai keeps every version, links every field, and lets you ask it questions.
Where things stand
Nothing below is a criticism of FDA. The publication does exactly what it was designed to do. The problem is that regulatory, IP, and portfolio work depends on history, correlation, and change — and none of that is what the Orange Book was built to deliver.
The hard copy
The electronic Orange Book
Everything around it
Patent information is published on or after the submission date defined in 21 CFR 314.53(d)(5). Listings published before 18 August 2003 identify only method-of-use claims, and may include drug substance or drug product claims that the listing never shows. Since 5 December 2016, an NDA holder submitting a patent that claims both the drug substance and the drug product need only specify one. FDA is explicit: an Orange Book listing cannot be relied on to determine the range of claims an NDA holder or patent owner may assert. Knowing when each listing appeared, and in what form, is the only way to read it properly.
Current options
Free
The official source. Authoritative, and deliberately minimal — current-state search plus a stack of PDFs and static lists.
Where it stops
≈ $295 / year
Collapse duplicate strength entries into single tables, hyperlink out to patent text and FDA records, and publish a monthly “What’s New” summary with a historical archive of expired patents.
Where it stops
$8,000 – $24,000 / year
Broad drug-patent suites: litigation dockets and complaints, generic entry screening, patents across 130+ countries, sales and reimbursement data, AI research assistants, automated reports.
Where it stops
What we're building
The published document, made navigable. Active table of contents, section search, integrated links from NDA number, product number, patent number, and exclusivity code straight through to the underlying record.
Split-screen product list against patent and exclusivity list. A single dashboard over data that currently lives in a dozen places. Verify any answer against the PDF, side by side, without leaving the page.
Search across every annual edition and supplement at once. Cross-field and cross-product queries. A daily cumulative database that turns “what changed, and when” into a question you can actually ask.
Roadmap
Ordered by dependency rather than by date. Every phase ships something you can use before the next one starts.
The Orange Book as it is published, but usable.
A database that accumulates instead of overwriting.
Current and historical state, both rendered as the document.
One query, every edition — not one edition at a time.
Single-surface navigation with PDF verification built in.
A daily email on what moved — and a searchable record of every move.
Your watchlist, evaluated against the daily diff.
Fee-based reports generated off the same data.
The people who use it shape it.
Sample queries
Each of these currently means opening several PDFs, reconciling them by hand, and hoping nothing changed in between. These are the queries Orange-Book.ai is designed to answer directly.
Access and pricing
Pricing TBD
Open access to a limited set of features, so you can see the document handling and search before you pay for anything.
Pricing TBD
Full access: cumulative database, cross-edition search, the dashboard, Daily-Difference™, and custom alerts.
Pricing TBD
Expert analysis on top of the platform — listing accuracy, loss-of-exclusivity estimates, portfolio reports, scenario modelling. Priced by task, by monitoring scope, or by project.
Waiting list members get first say on packaging and price points before anything is published.
Beyond the roadmap
Green-Book.ai for approved animal drug products, and Purple-Book.ai for licensed biological products with reference product exclusivity and biosimilarity evaluations. Both are planned, with features analogous to Orange-Book.ai.
Early access
Orange-Book.ai is in development. Tell us who you are and what you need it to answer, and we'll bring you in as capability lands.