FDA Orange Book Scraper: Drug Patents, Exclusivity and Generic Competition

This FDA Orange Book scraper reads the official list of approved drug products with their patents and exclusivities and turns it into clean data. Search a drug, a brand, a company or a whole class and see in one row when its protection ends, how many patents it has, which patents cover the active ingredient or the formulation, which exclusivity periods apply, whether generics are already approved and who makes them.

Beyond single products, the expiry calendar answers the question that pharma teams ask every week: what comes off protection next. It lists patent and exclusivity expiries in date order, with the days left, the brand, the company and whether a generic already exists.

Generic drug makers, brand companies, investors, analysts, lawyers and consultants use it to plan launches, to watch patent cliffs and to find drugs with no generic competition yet.

What can you do with this Orange Book scraper?

• See when the protection of a brand drug ends and how many days are left
• Build a calendar of patent and exclusivity expiries for the next months
• Find brand drugs that still have no approved generic
• Separate substance, product and use patents
• Read the exclusivity codes with their meaning, for example new chemical entity or orphan drug
• List all products of a company with their patents
• Find the generic makers that share an ingredient, dosage form and route
• Follow newly approved products by date
• Filter by therapeutic equivalence code, route, dosage form or marketing type
• Export to CSV or Excel, or send the calendar to your own tools

What data can you extract from the Orange Book?

Mode	One row is	Highlights
Products	One approved product	Ingredient, brand, dosage form, route, strength, company, application type and number, product number, marketing type, equivalence code, approval date, reference drug flags, number of patents, first and last patent expiry, substance and product patent flags, exclusivity codes and last exclusivity expiry, date protection ends, days left, protection status, number of approved generic makers, all patents with days left, all exclusivities with meaning, data version
Patents	One patent of a product	Product fields, patent number, expiry date, days to expiry, expired flag, substance and product flags, use code, delisted flag, submission date, generic makers
Expiry calendar	One patent or exclusivity that ends	Kind, ingredient, brand, company, application, strengths, patent number or exclusivity code with meaning, expiry date, days to expiry, generic makers

How to scrape the Orange Book

1. Choose Approved drug products, Patents or Expiry calendar.
2. Type ingredients, brand names or companies.
3. For the calendar, set the expiry dates, or leave them empty to see everything that is coming.
4. Optionally keep only reference drugs or products without an approved generic.
5. Set Max Items and click Start.
6. Export the dataset as CSV, Excel or from the Apify console.

Input example

{
  "mode": "expirations",
  "expiresFrom": "2027-01-01",
  "expiresTo": "2027-12-31",
  "genericAvailability": "noGeneric",
  "onlyReferenceListed": true,
  "maxItems": 200
}

Product output example

{
  "ingredient": "Semaglutide",
  "tradeName": "Ozempic",
  "applicant": "Novo Nordisk Inc",
  "applicationNumber": "N209637",
  "patentCount": 7,
  "lastPatentExpiry": "2041-02-17",
  "protectionEndsOn": "2041-02-17",
  "daysUntilProtectionEnds": 5221,
  "protectionStatus": "Protected",
  "approvedGenericMakers": 0
}

Expiry calendar output example

{
  "kind": "Patent",
  "ingredient": "Telavancin Hydrochloride",
  "tradeName": "Vibativ",
  "strengths": ["EQ 250MG BASE/VIAL", "EQ 750MG BASE/VIAL"],
  "expires": "2027-01-01",
  "daysUntilExpiry": 60,
  "approvedGenericMakers": 0
}

How much does it cost to scrape the Orange Book?

You pay per result: $28 per 1,000 rows plus a tiny start fee. The free plan returns up to 10 rows per run. The calendar merges repeated strengths into one row, so a full year of expiries is a few hundred rows.

Tips for better results

• The date when protection ends is the later of the last listed patent and the last exclusivity. It is an estimate for planning. Lawsuits, patent challenges, settlements and extra periods can change the real date of a generic launch.
• Delisted patents are left out by default. Turn on the option to include them.
• A generic counts as approved when an approved generic application has the same ingredient, dosage form and route. Check the strength and the equivalence code for exact matches.
• Method of use patents have a use code. The text of each use code is published by the agency and is not part of the data files.
• Some old products have no approval date because they were approved before 1982. The row says so.
• The FDA publishes the Orange Book data files every month. The month of the data is in every row.
• Exclusivity codes with a number after the dash, such as ODE-267 or I-975, belong to a family. The meaning column names the family.
• For a weekly report, schedule the calendar with the expiry dates of the next 12 months.

Who uses Orange Book data?

• Generic manufacturers find launch opportunities and plan filings.
• Brand companies watch their own protection and that of competitors.
• Investors and analysts model patent cliffs.
• Lawyers and consultants research patents and exclusivity.
• Pharmacy and payer teams follow expected generic entry.

Automate and connect

Schedule the Actor every month, right after the data update, and send the new expiries to Slack, Google Sheets, Zapier, Make or n8n, or trigger a webhook when a run ends.

FAQ

Do I need an account or a login? No. The Actor works without any login.

Does it include biologics? No. Biologic products are listed in the Purple Book of the FDA, not in the Orange Book.

Why do I see the same drug several times? There is one row per product, which means one per strength and dosage form. The calendar merges strengths of the same application.

What does the equivalence code mean? Codes that start with A mean that the agency considers the generic therapeutically equivalent to the brand. Codes that start with B mean that it does not.

Is the expiry date the date of the first generic? No. It is the end of the listed protection. A generic can come later, or earlier if a patent is invalidated.

Is this legal advice? No. It is public information. Ask a patent lawyer before you plan around an expiry date.

Legal note

This Actor collects information that is publicly visible on the website. Check the source site's terms and your local rules before using the data.

Support

Missing a field or found a bug? Open an issue from the Actor page.