FDA Orange Book Scraper

Extract FDA Orange Book data -- approved drug products, patent expiration dates, generic equivalents, therapeutic equivalence, and exclusivity periods. No API key required.

Search the FDA's official database of approved drug products with therapeutic equivalence evaluations. Essential for pharma business development, generic drug planning, and patent cliff analysis.

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What does it do?

FDA Orange Book Scraper downloads and parses the FDA's Orange Book data files (Products, Patents, Exclusivity) and returns structured data about approved drugs. It extracts product information, patent expiration dates, therapeutic equivalence codes, and market exclusivity periods into clean, normalized JSON. Returns consistent output -- ready for analysis, BD pipelines, or consumption by AI agents via MCP.

👥 Who Uses This

💊 Generic Drug Business Development Teams

You're identifying patent cliff opportunities — branded drugs with expiring patents where ANDA filing makes economic sense. The Orange Book has every patent expiration date, every exclusivity period, and every therapeutic equivalence rating. This actor gives you that data as structured JSON without manually searching the FDA website drug by drug.

{
    "mode": "search_products",
    "ingredient": "apixaban",
    "maxResults": 50
}

Filter by applicantCode to pull a specific company's full approved product portfolio. Cross-reference patent_expire_date with current market exclusivity to identify the earliest generic entry window.

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🏢 Pharma Business Development and Licensing Teams

You're evaluating in-licensing targets or identifying market entry timing for new therapeutic areas. Orange Book exclusivity periods (3-year, 5-year, 7-year orphan) define how long a product is protected from generic competition — critical for deal valuation.

{
    "mode": "get_exclusivity",
    "ingredient": "semaglutide",
    "maxResults": 20
}

The exclusivity_code field maps to specific protection types (NCE, ODE, pediatric, etc.). Combine with Clinical Trials Scraper to cross-reference pipeline compounds against their patent and exclusivity runway.

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📈 Investment Analysts and Healthcare Sector Researchers

You're building financial models around patent cliffs, generic entry risk, or pipeline exclusivity. Orange Book data is the authoritative source for when branded revenue protection ends — but extracting it at scale from the FDA website is painful without structured API access.

{
    "mode": "get_patents",
    "ingredient": "pembrolizumab",
    "maxResults": 50
}

Pull patent expiration dates and therapeutic equivalence codes across a portfolio of interest. Export to CSV for modeling generic entry scenarios, revenue cliff timing, or competitive moat assessment.

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⚖️ Regulatory Strategy Consultants and Affairs Teams

You need to understand therapeutic equivalence ratings (A vs B codes), reference listed drug (RLD) designations, and the approval pathway for products you're developing or advising on. Orange Book TE codes determine formulary substitutability and are central to ANDA strategy.

{
    "mode": "search_products",
    "ingredient": "atorvastatin",
    "applicantCode": "PARKE",
    "maxResults": 50
}

The te_code field identifies therapeutic equivalence rating. AB = substitutable; BX = data insufficient; BC = dose form not substitutable. Critical context for substitution policy and formulary decisions.

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🤖 AI/LLM Engineers and Pharma AI Builders

You're building pipelines for drug intelligence — competitive analysis agents, portfolio monitoring tools, or deal screening assistants that need to reason about market exclusivity and patent timelines without manual data entry.

MCP tool config:

{
    "mcpServers": {
        "fda-orange-book": {
            "url": "https://mcp.apify.com?tools=labrat011/fda-orange-book-scraper",
            "headers": {
                "Authorization": "Bearer <APIFY_TOKEN>"
            }
        }
    }
}

Combine with FDA Drug Labels and FDA Adverse Events in the same MCP config to give your agent a complete approved-drug intelligence stack — labeling, safety signals, and patent status as callable tools.

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Input

Choose a scraping mode and provide your search filters.

Mode 1: Search Products

Search for approved drug products by ingredient, trade name, or applicant.

{
    "mode": "search_products",
    "ingredient": "atorvastatin",
    "maxResults": 100
}

Search for generics (ANDA):

{
    "mode": "search_products",
    "ingredient": "metformin",
    "applicationType": "A",
    "teCode": "AB",
    "maxResults": 50
}

Mode 2: Get Product

Look up all products for a specific NDA/ANDA application number.

{
    "mode": "get_product",
    "applicationNumber": "020702"
}

Mode 3: Search Patents

Find patent information for drugs.

{
    "mode": "search_patents",
    "ingredient": "adalimumab",
    "maxResults": 50
}

Search by patent number:

{
    "mode": "search_patents",
    "patentNumber": "6090382",
    "maxResults": 25
}

Mode 4: Search Exclusivity

Find drugs with market exclusivity periods.

{
    "mode": "search_exclusivity",
    "ingredient": "pembrolizumab",
    "maxResults": 25
}

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Output

Each product record includes:

Field	Description
ingredient	Active ingredient(s)
trade_name	Brand/trade name
dosage_form	Dosage form (tablet, injection, etc.)
route	Route of administration
strength	Drug strength
application_type	N = NDA (innovator), A = ANDA (generic)
application_number	FDA application number
applicant	Company holding the application
approval_date	FDA approval date
te_code	Therapeutic equivalence code
rld	Reference Listed Drug (true/false)
rs	Reference Standard (true/false)
product_type	RX, OTC, or DISCN
patents	List of patents with expiration dates
exclusivities	List of exclusivity periods with expiration dates
orange_book_url	Link to FDA Orange Book page

Patent information includes:

Field	Description
patent_number	US patent number
patent_expire_date	Patent expiration date
drug_substance_flag	Patent covers drug substance
drug_product_flag	Patent covers drug product
patent_use_code	Method of use patent code

Example output

{
    "schema_version": "1.0",
    "type": "product",
    "ingredient": "ATORVASTATIN CALCIUM",
    "trade_name": "LIPITOR",
    "dosage_form": "TABLET",
    "route": "ORAL",
    "strength": "10MG",
    "application_type": "N",
    "application_number": "020702",
    "applicant": "PFIZER",
    "approval_date": "Dec 17, 1996",
    "te_code": "AB",
    "rld": true,
    "rs": true,
    "product_type": "RX",
    "patents": [
        {
            "patent_number": "5273995",
            "patent_expire_date": "Jun 28, 2016",
            "drug_substance_flag": true,
            "drug_product_flag": false,
            "patent_use_code": ""
        }
    ],
    "exclusivities": [],
    "orange_book_url": "https://www.accessdata.fda.gov/scripts/cder/ob/results_product.cfm?Appl_Type=N&Appl_No=020702"
}

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Therapeutic Equivalence Codes

Code	Meaning
AA	No bioequivalence issues (solutions)
AB	Bioequivalent - meets requirements
AN	Aerosols
AO	Injectable oils
AP	Injectable aqueous
AT	Topical products
BC	Extended-release - not bioequivalent
BD	Documented bioequivalence problems
BE	Enteric coated
BN	Aerosols - not bioequivalent
BP	Injectable - not bioequivalent
BR	Sustained-release - not bioequivalent
BS	Standard - not bioequivalent
BT	Topical - not bioequivalent
BX	Insufficient data

"A" ratings = therapeutically equivalent (substitutable) "B" ratings = NOT therapeutically equivalent

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Integrations

Apify API

curl "https://api.apify.com/v2/acts/labrat011~fda-orange-book-scraper/runs" \
  -X POST \
  -H "Authorization: Bearer <APIFY_TOKEN>" \
  -H "Content-Type: application/json" \
  -d '{
    "mode": "search_patents",
    "ingredient": "semaglutide",
    "maxResults": 25
  }'

Python

from apify_client import ApifyClient

client = ApifyClient("<APIFY_TOKEN>")

run = client.actor("labrat011/fda-orange-book-scraper").call(run_input={
    "mode": "search_products",
    "ingredient": "tirzepatide",
    "maxResults": 50
})

for item in client.dataset(run["defaultDatasetId"]).iterate_items():
    print(f"{item['trade_name']} ({item['applicant']})")
    for patent in item['patents']:
        print(f"  Patent {patent['patent_number']} expires: {patent['patent_expire_date']}")

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MCP Integration

This actor works as an MCP tool through Apify's hosted MCP server. No custom server needed.

• Endpoint: https://mcp.apify.com?tools=labrat011/fda-orange-book-scraper
• Auth: Authorization: Bearer <APIFY_TOKEN>
• Transport: Streamable HTTP
• Works with: Claude Desktop, Cursor, VS Code, Windsurf, Warp, Gemini CLI

Example MCP config (Claude Desktop / Cursor):

{
    "mcpServers": {
        "fda-orange-book-scraper": {
            "url": "https://mcp.apify.com?tools=labrat011/fda-orange-book-scraper",
            "headers": {
                "Authorization": "Bearer <APIFY_TOKEN>"
            }
        }
    }
}

AI agents can use this actor to look up patent expiration dates, find generic equivalents, check therapeutic equivalence, and track exclusivity periods -- all as a callable MCP tool.

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Cost

This actor uses pay-per-result (PPE) pricing — you pay only for records returned.

• $2.00 per 1,000 results ($0.002 per record)
• Free tier: 25 results per run — no subscription required
• Paid tier: Up to 1,000 results per run
• No proxy costs — downloads direct from FDA servers, no residential proxies needed
• Data freshness: Updated monthly by FDA

Typical run costs:

• 100 products (ingredient search) → $0.20
• 500 products (full class sweep) → $1.00
• 1,000 products (portfolio analysis) → $2.00

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FAQ

What is the Orange Book?

The FDA Orange Book (officially "Approved Drug Products with Therapeutic Equivalence Evaluations") lists all drugs approved by FDA under the Federal Food, Drug, and Cosmetic Act. It's used to determine which generic drugs are therapeutically equivalent to brand-name drugs.

What's the difference between NDA and ANDA?

• NDA (New Drug Application) - For new/innovator drugs. Requires full safety and efficacy data.
• ANDA (Abbreviated NDA) - For generic drugs. References an RLD and requires bioequivalence data.

What is a Reference Listed Drug (RLD)?

The RLD is the brand-name drug that a generic manufacturer must reference when submitting an ANDA. The generic must be pharmaceutically equivalent and bioequivalent to the RLD.

How often is the data updated?

The FDA updates the Orange Book data files monthly. This actor downloads the latest data file on each run.

Why do some drugs have no patents listed?

Patents may have expired, the product may be a generic with no listed patents, or the innovator may not have submitted patent information to FDA.

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🔗 Related Actors

Actor	What it does	Pairs well when...
FDA Drug Labels Scraper	FDA-approved drug labeling data	Pull the full label for products identified in patent/exclusivity searches
FDA Adverse Events Scraper	FAERS post-market safety reports	Check post-market safety signals for drugs approaching patent expiry
Clinical Trials Scraper	ClinicalTrials.gov study data	Map pipeline compounds to their patent and exclusivity timelines
PubMed Scraper	35M+ biomedical abstracts from NCBI	Find clinical evidence supporting approval decisions and TE ratings

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Resources

• FDA Orange Book
• Orange Book Search
• Orange Book Preface
• Patent & Exclusivity FAQ
• Apify Documentation

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License

This actor is provided under the MIT License. Orange Book data is from the FDA and is in the public domain.