FDA Orange Book Dataset

The FDA Orange Book, Built for Analysts

The Orange Book enriched with USPTO patents, approved indications, and normalized company data delivered as a queryable SQLite database with full monthly change history.

Request data export →

Try the Interactive Dashboard

Explore drugs losing exclusivity over the next five years. The full export covers all FDA approval types, monthly change history from October 2023 to present, pre-computed LOE estimates, and USPTO patent detail.

Explore a Sample of the Data

200 products from 123 companies

Representative sample. The full dataset covers all NDA and ANDA applications. 48,215 products with monthly change history and USPTO patent detail and structured label and indication data.

Exclusivity Timeline (2026–2031)

Click any bar to filter the table by month. Click a company below to filter the chart.

Top Companies in Preview

Tap to expand

Search & Filter

Showing 0 of 0 products
Request data export →

Use Cases

What You Can Do With It

Structured for direct analysis. No data cleaning, no manual joins required.

Economics and Strategy Consulting

  • ● Pull all NDAs losing protection in the next 5 years is one query against loe_estimates, ready in seconds
  • ● Reconstruct a drug's patent position as of any month in the last 29 months for litigation or regulatory work
  • ● Support client due diligence with primary-source FDA records

Investment Research

  • ● Rank a company's patent cliff by product using loe_estimates joined to the ticker field
  • ● Join RxCUI and NDC fields to claims or formulary data for utilization and revenue modeling
  • ● Map competitive generic entry using first_generic_entry dates and generic_count by formulation

Pharmaceutical Business Development

  • ● Map the full exclusivity landscape of a therapeutic area to see what's expiring, when, and for whom
  • ● Compare exclusivity positions across M&A targets using a consistent, normalized dataset
  • ● Track month-over-month patent modifications using our change tracking to catch quiet extensions or changing strategies

Generic Drug Development

  • ● Find brand NDAs with patents expiring in 1–3 years, filtered by route, dosage form, and indication
  • ● Track competitor ANDA filings and approval dates by therapeutic area
  • ● Monitor exclusivity changes monthly to catch new grants or unexpected extensions

What's Included

One dataset, multiple primary sources

Integrated from FDA, USPTO, and openFDA. Normalized, documented, and ready for analysis.

RxDataLabNormalize · Enrich · Track Changes · Compute EstimatesRxDataLab.comFDA ElectronicOrange BookopenFDADrug Labels (SPL)USPTOPatentsViewDrug ApplicationsDrug FormulationsUSPTO PatentsDrug LabelsRxCUI · UNII · NDC · EPC2+ YearsChange HistoryLOE EstimatesFirst Generic Entry
48,215
FDA-approved drug products
21,112
patent-to-product linkages
30
months of change history

Data Coverage

  • Current Dataset April 2026 snapshot with current patent and exclusivity data
  • Historical Data 30 months of Orange Book change history: patent modifications, exclusivity grants, application transfers
  • Integrated Data USPTO patent details, FDA labels & indications, and RxDataLab companies merged with FDA applications

How to Access

  • SQLite Database
    Primary format. Open and query with Python (sqlite3), R (RSQLite), or any database tool. Includes AGENTS.md context for LLM-assisted analysis and ~25 ready-to-run example queries covering LOE timelines, patent cliff, company portfolios, and change history.
  • CSV Files
    One file per table including applications, products, patents, exclusivity, drug labels, LOE estimates, and monthly change logs. Import directly into Excel, Pandas, or any tabular tool.
  • Platform Access
    Search, filter, and export directly from app.rxdatalab.com. Useful for spot checks and single-drug lookups without opening a database.

Fields Include:

  • • Application number and type (NDA / ANDA)
  • • Trade name and active ingredient
  • • Sponsor name (raw FDA) + RxDataLab canonical company name
  • • Stock ticker and SEC CIK (where available)
  • • Approval date, dosage form, route, strength
  • • Patent number and expiration date
  • • Patent use codes + definition
  • • Pediatric exclusivity flag
  • • USPTO patent enrichment
  • • Therapeutic equivalence (TE) code
  • • Approved indication text (from FDA drug label)
  • • FDA pharmacological class (EPC)
  • • RxNorm CUI for links to claims and formulary data
  • • NDC code for links to dispensing databases
  • • UNII links to FDA FAERS adverse event data
  • • Boxed warning text (when present)
Cross-reference identifiersin the RxDataLab datasetRxDataLab datasetsLinkable external sourcesRxDataLab.comRxCUINDCUNIISEC CIKCompany IDCompany Intelligence& Pipeline DataClaims &Formulary DataPrescriptionDispensing DataSEC / EDGARFilingsFDA FAERSAdverse Events
Full documentation:
Dataset overview Schema reference Exclusivity types & LOE methodology Change history Patent analysis

Try the Data

Download a sample export

Enter your email and we'll give you access to a sample export with the same format as the full data.

Data Quality

Primary Sources. Documented Methodology. No Black Boxes.

We pull directly from FDA, USPTO, and openFDA. No third-party vendor feeds, no repackaged commercial data.

Why Our Data are Different

  • • AI-Ready: Each export includes an AGENTS.md context file, a normalized schema, and ~25 example SQL queries. This allows LLMs to quickly get oriented and assist analysts in advanced domain-specific analysis.
  • • Trusted by consulting and research firms: Licensed by economics consulting and investment research teams for client engagements.
  • • Transparent LOE methodology: All methods and calculations are transparent and documented. No black boxes, no proprietary adjustments.
  • • Company intelligence built in: 300+ sponsor names are normalized to canonical company identifiers with stock tickers and SEC CIK numbers, enabling M&A and portfolio analysis without manual cleanup.
  • • Primary sources only: We pull directly from FDA, USPTO, and openFDA. No third-party vendor resale, no repackaged commercial feeds. Data lineage traces to the original government source.

Data Sources

  • • FDA Electronic Orange Book monthly releases, ingested within 24 hours of publication
  • • FDA exclusivity and patent use code definitions Over 4,000 use codes and 2,000 exclusivity codes
  • • USPTO Patents Via PatentsView, includes patent titles, grant dates, application numbers, and filing dates
  • • FDA Structured Product Labels via openFDA SPL includes approved indication text, pharmacological class
  • • RxDataLab company enrichment with canonical names, tickers, SEC CIK across raw FDA sponsor strings

Frequently Asked Questions

Can I use this data for a client project?

Yes. Economic consulting and investment research teams use this data for client engagements. We can package the data in whatever format your team needs. Contact [email protected] to discuss scope and pricing.

How often is the data updated?

We create a new release of the data every month in-line with FDA data publishing timelines. You can subscribe for monthly updates or single-use downloads.

How can I access the data?

As a one-time export (SQLite database + CSV files + documentation) or as an annual data license with monthly updates. Data is delivered in the same format as the sample data. Contact us to discuss what you need, including formats or delivery mechanism. Most clients prefer to start with a one-time export for a specific project, then move to a recurring feed.

What other data can I join this to?

The dataset includes RxCUI, NDC, UNII, and SEC CIK identifiers (where available). RxCUI and NDC enable joins to claims, formulary, and prescription data sources. SEC CIK connects to EDGAR filings and SEC disclosures. Coverage of these fields is highest for NDA applications from public companies with active commercial products - most ANDA filers are private generic manufacturers and will be unmatched.

Why not just use FDA's free data?

FDA and other open regulatory agency data provide the foundation for this dataset. We then add USPTO patent details, structured label and indication data, normalize company names to CIK’s and stock tickers (where available), and maintain a clean AI-ready schema designed for analysis. Our goal is to provide the context and formats needed to jump right to analysis without extensive manual or AI-assisted data cleaning and joining.

Do you offer discounts for academics/nonprofits/journalists?

Yes. Contact [email protected] and we’ll work something out.

Get the Data

Get the Data

One-time exports for a specific project, or annual licenses with monthly updates. We'll package the data in whatever format your team needs.

or email [email protected]

Use governed by the RxDataLab Terms of Service · Privacy Policy