Know When Drugs Lose US Patent Protection
FDA Orange Book enriched with USPTO patents, FDA exclusivity, company ownership, and change history
We track changes the FDA doesn't preserve. Find generic entry windows. Track pharma portfolios. Spot ownership transfers. Company names normalized to stock tickers. Clean and analysis-ready data for Excel, SQL, or AI tools.
Try the Interactive Dashboard
Explore a sample of our data showing drugs losing exclusivity in the next 5 years. The full dataset includes complete historical data and all FDA approval types.
Explore a Sample of the Data
127 products from 39 companies (preview sample)
This preview shows a curated sample. The full dataset includes 47,588 products from 500+ companies with complete historical 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
| Company | Trade Name | Est. End of Exclusivity | Exclusivity Reason |
|---|
What Can You Do With This Data?
Real analyses from our team using the Orange Book dataset
Generic Competition Analysis
Track when brand-name drugs face generic competition
SELECT ApprovalDate, COUNT(*) as GenericCount
FROM Products WHERE ApplType='ANDA'
GROUP BY ReferenceNDA
Market Entry Opportunities
Find drugs with expiring exclusivity and no generics
SELECT TradeName, ExclusivityDate
WHERE ExclusivityDate < '2027'
AND GenericCount = 0
Prioritize generic drug development pipeline
Patent Cliff Forecasting
Model revenue impact from exclusivity expiration
SELECT Applicant, COUNT(*) as ExpiringProducts
FROM Patents WHERE PatentExpireDate
BETWEEN '2026' AND '2027'
Identify companies facing multiple patent expirations
Ownership Change Detection
Track M&A and sponsor changes over time
SELECT p1.TradeName, p1.Applicant as OldOwner,
p2.Applicant as NewOwner, p2.SnapshotDate
FROM OBProduct_History p1
JOIN OBProduct_History p2 ON p1.ApplNo = p2.ApplNo
WHERE p1.Applicant != p2.Applicant
Requires historical data tables (Pro tier only)
These are just examples. With the full dataset, you have complete flexibility to answer your specific research questions with SQL, Python, R, or Excel.
🔄 Historical Data Analysis
Track changes over time with Pro tier: ownership transfers, patent additions/removals, status updates, and competitive strategy shifts. Basic tier includes current snapshot only.
Want the Complete Dataset?
Get all 47,588 products with complete patent linkages, exclusivity tracking, and 24 months of historical data. Export to Excel, CSV, or SQLite.
See Pricing & Buy NowWhat's Included
Curated data in Excel, CSV, and SQLite formats
Data Coverage
- Current Dataset January 2026 snapshot with complete patent & exclusivity data
- Historical Data (Pro Only) 24 monthly snapshots enabling change detection: ownership transfers, patent additions, status updates
- Integrated Data USPTO patent details merged with FDA applications
File Formats
- 📊Excel (.xlsx)Formatted worksheets, ready to analyze
- 📁CSV filesUTF-8 encoded, one per table
- 💾SQLite databaseFull relational DB with indexes
- 📖DocumentationComplete field descriptions & examples
Fields Included in Every Drug Product
- • Normalized company name with stock ticker
- • Original FDA applicant name
- • Trade name, active ingredient
- • Strength, dosage form
- • Route of administration
- • Approval dates, application numbers
- • Patent numbers & expiration dates
- • Exclusivity codes & dates
- • Therapeutic equivalence (TE) codes
- • RLD status, distribution type
Who Uses This Data
Generic Drug Developers
- ● Identify upcoming generic entry windows
- ● Track competitor patent expirations
- ● Prioritize development pipeline
- ● Analyze therapeutic area opportunities
Pharmaceutical Analysts
- ● Model revenue erosion from generics
- ● Track pharma company portfolios
- ● M&A due diligence on exclusivity
- ● Forecast market entry timelines
Healthcare Researchers
- ● Study drug availability trends
- ● Analyze approval patterns over time
- ● Evaluate exclusivity policy impacts
- ● Research generic competition effects
Financial Analysts
- ● Factor patent cliffs into valuations
- ● Track exclusivity loss events
- ● Analyze sector approval trends
- ● Identify pharma investment risks
Choose Your Plan
Analysis-ready data delivered instantly via download links
Basic
Current snapshot only
- Complete current dataset
- All file formats (Excel, CSV, SQLite)
- Complete field documentation
- Example SQL queries included
- 14-day money-back guarantee
- ❌ No historical data tables
- ❌ No monthly updates
Pro
Living dataset with history
- Everything in Basic
- 3 months of monthly updates
- Historical data (track changes over time)
- See ownership changes, patent additions, status updates
- Month-over-month diff analysis capabilities
- Historical analysis query examples
Use governed by the RxDataLab Data License
Trusted Data, Expert Curation
Why Our Data is Different
- • AI Ready - Consistent schema, normalized company names, comprehensive documentation, and an AGENTS.md context file make it perfect for LLMs and automated analysis
- • Company Intelligence - Products have normalized company names mapped to stock tickers and acquisition history, enabling portfolio analysis and M&A tracking
- • Expertly curated - Maintained by pharma industry analysts with domain expertise
- • Quality checked - Every update manually validated for data integrity
- • Actually usable - Cleaned, deduplicated, and formatted for immediate analysis
Data Sources
- • FDA Orange Book (official monthly releases)
- • FDA Exclusivity Lookup Codes
- • USPTO Patent Database (PatentsView)
- • Manual and automated quality assurance + validation
Updated Monthly
Updates delivered monthly after FDA updates • Data lag: 5-7 days after FDA publishes
Frequently Asked Questions
How often is the data updated?
The FDA publishes Orange Book updates monthly (usually around the 25th). We process and deliver updates within 5-7 days. Pro customers receive automatic update emails each month.
What file formats do you provide?
Excel (.xlsx), CSV (UTF-8), and a SQLite database. All formats contain the same complete data, just formatted differently for your preferred analysis tool.
Can I share this with my team?
Yes! The license allows sharing within your organization for internal use. You cannot redistribute publicly or resell the data.
How far back does the historical data go?
The Pro dataset includes monthly snapshots going back ~2 years. This allows you to see month-over-month changes in approvals, discontinuations, and patent status. We’re continuously expanding historical coverage.
Why Not Just Use FDA's Free Data?
The FDA provides monthly data dumps of the Electronic Orangebook, which is the starting point for this dataset. We then add patent data, exclusivity codes, process and organize company names, and organize the data into useful formats for analysis.
Do you offer refunds?
Yes, 14-day money-back guarantee, no questions asked. Email [email protected] with your order number.
What if I need help using the data?
We are happy to provide tips and clarifications about the data, and provide example queries and documentation when you purchase. If you need help with a bigger analysis project, we are available for consulting projects.
Can I upgrade from Basic to Pro later?
Yes! Email us at [email protected] and we’ll credit your Basic purchase toward Pro.
Do you offer discounts for academics/nonprofits/journalists?
Yes, we offer discounts for academic researchers, nonprofit organizations, and journalists. Contact [email protected].
Get Started Today
Stop spending hours wrestling with FDA data. Get analysis-ready Orange Book data in minutes.
Questions? Email [email protected]
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