# FDA Orange Book Scraper: Patents and Exclusivity (`parselab/fda-orange-book-patents-exclusivity-scraper`) Actor

Scrape the FDA Orange Book for approved drugs with their patents, exclusivities and generic competition. See when protection ends, which brands have no generic yet, patent kinds, use codes and equivalence codes, plus a calendar of patent and exclusivity expiries. Export to CSV or Excel.

- **URL**: https://apify.com/parselab/fda-orange-book-patents-exclusivity-scraper.md
- **Developed by:** [ParseLab](https://apify.com/parselab) (community)
- **Categories:** Business, Other
- **Security:** Limited permissions
- **Stats:** 2 total users, 1 monthly users, 100.0% runs succeeded, 0 bookmarks
- **User rating**: No ratings yet

## Pricing

from $21.00 / 1,000 results

This Actor is paid per event. You are not charged for the Apify platform usage, but only a fixed price for specific events.
Since this Actor supports Apify Store discounts, the price gets lower the higher subscription plan you have.

Learn more: https://docs.apify.com/actors/running/actors-in-store.md#pay-per-event

## What's an Apify Actor?

An Actor is a serverless cloud program that runs on the Apify platform. It has two run modes.
In Batch mode, an Actor accepts a well-defined JSON input, performs an action which can take anything from a few seconds to a few hours,
and optionally produces a well-defined JSON output, datasets with results, or files in key-value store.
In Standby mode, an Actor provides a web server which can be used as a website, API, or an MCP server.

Apify vocabulary and the platform model are defined once, in the agent quickstart at https://apify.com/agents.md.

## How to integrate an Actor?

If asked about integration, you help developers integrate Actors into their projects.
You adapt to their stack and deliver integrations that are safe, well-documented, and production-ready.

Do not guess an integration path. Every one of them is in the agent quickstart at https://apify.com/agents.md: the Apify MCP server, Agent Skills with the Apify CLI, the JavaScript and Python clients, the REST API, and the account-free path for an agent with no human to sign in. It also carries the rule on stating cost before the first paid run.

For examples already wired to this Actor's own input schema, see the [API](#api) section below.

Each client library has reference documentation the quickstart does not restate: [JavaScript/TypeScript](https://docs.apify.com/api/client/js/docs.md) (`npm install apify-client`) and [Python](https://docs.apify.com/api/client/python/docs.md) (`pip install apify-client`).

# README

## 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

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

### Product output example

```json
{
  "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

```json
{
  "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.

# Actor input Schema

## `maxItems` (type: `integer`):

Free users: Limited to 10 items (preview). Paid users: Optional, max 1,000,000.

## `mode` (type: `string`):

Products returns one row per approved drug product with all its patents, exclusivities and generic competition. Patents returns one row per patent. Expiry calendar returns one row per patent or exclusivity that ends, in date order.

## `ingredients` (type: `array`):

Part of an ingredient name, for example semaglutide, apixaban or metformin.

## `tradeNames` (type: `array`):

Part of a brand name, for example Eliquis or Ozempic.

## `applicants` (type: `array`):

Part of the name of the application holder, for example Pfizer, Novo or Teva.

## `applicationNumbers` (type: `array`):

FDA application numbers, for example 021436 or N021436.

## `applicationTypes` (type: `array`):

NDA for brand drugs or ANDA for generic drugs.

## `productTypes` (type: `array`):

RX for prescription, OTC for over the counter, DISCN for discontinued products.

## `teCodes` (type: `array`):

For example AB, AB1, AP or BX. Codes starting with A mean that a generic can replace the brand.

## `routes` (type: `array`):

Part of the route of administration, for example oral, injectable or topical.

## `dosageForms` (type: `array`):

Part of the dosage form, for example tablet, capsule or solution.

## `onlyReferenceListed` (type: `boolean`):

Keep the brand products that generics must match.

## `approvedFrom` (type: `string`):

First approval date, in the form 2020-01-31.

## `approvedTo` (type: `string`):

Last approval date.

## `onlyWithPatents` (type: `boolean`):

Keep products that still have at least one patent in the list.

## `onlyWithExclusivity` (type: `boolean`):

Keep products with a period of market exclusivity.

## `genericAvailability` (type: `string`):

Brand products with no approved generic are the ones where a first generic may still come. A generic counts when an approved generic has the same ingredient, dosage form and route.

## `expiresFrom` (type: `string`):

Patents and expiry calendar modes. First expiry date, in the form 2027-01-01. Without dates the calendar shows all upcoming expiries.

## `expiresTo` (type: `string`):

Patents and expiry calendar modes. Last expiry date.

## `expirationKinds` (type: `array`):

Expiry calendar mode. Patents, exclusivities or both.

## `patentFlags` (type: `array`):

Patents and expiry calendar modes. Substance patents protect the active ingredient, product patents the formulation, use patents a method of use.

## `includeDelisted` (type: `boolean`):

Patents and expiry calendar modes. Adds patents that the application holder asked to remove from the list.

## `sortBy` (type: `string`):

Products mode.

## Actor input object example

```json
{
  "maxItems": 10,
  "mode": "products",
  "ingredients": [
    "semaglutide"
  ],
  "onlyReferenceListed": false,
  "onlyWithPatents": false,
  "onlyWithExclusivity": false,
  "genericAvailability": "any",
  "includeDelisted": false,
  "sortBy": "name"
}
```

# Actor output Schema

## `overview` (type: `string`):

No description

# API

You can run this Actor programmatically using our API. Below are code examples in JavaScript, Python, and CLI, as well as the OpenAPI specification and MCP server setup.

## JavaScript example

```javascript
import { ApifyClient } from 'apify-client';

// Initialize the ApifyClient with your Apify API token
// Replace the '<YOUR_API_TOKEN>' with your token
const client = new ApifyClient({
    token: '<YOUR_API_TOKEN>',
});

// Prepare Actor input
const input = {
    "maxItems": 10,
    "ingredients": [
        "semaglutide"
    ]
};

// Run the Actor and wait for it to finish
const run = await client.actor("parselab/fda-orange-book-patents-exclusivity-scraper").call(input);

// Fetch and print Actor results from the run's dataset (if any)
console.log('Results from dataset');
console.log(`💾 Check your data here: https://console.apify.com/storage/datasets/${run.defaultDatasetId}`);
const { items } = await client.dataset(run.defaultDatasetId).listItems();
items.forEach((item) => {
    console.dir(item);
});

// 📚 Want to learn more 📖? Go to → https://docs.apify.com/api/client/js/docs

```

## Python example

```python
from apify_client import ApifyClient

# Initialize the ApifyClient with your Apify API token
# Replace '<YOUR_API_TOKEN>' with your token.
client = ApifyClient("<YOUR_API_TOKEN>")

# Prepare the Actor input
run_input = {
    "maxItems": 10,
    "ingredients": ["semaglutide"],
}

# Run the Actor and wait for it to finish
run = client.actor("parselab/fda-orange-book-patents-exclusivity-scraper").call(run_input=run_input)

# Fetch and print Actor results from the run's dataset (if there are any)
print(f"💾 Check your data here: https://console.apify.com/storage/datasets/{run.default_dataset_id}")
for item in client.dataset(run.default_dataset_id).iterate_items():
    print(item)

# 📚 Want to learn more 📖? Go to → https://docs.apify.com/api/client/python/docs/quick-start

```

## CLI example

```bash
echo '{
  "maxItems": 10,
  "ingredients": [
    "semaglutide"
  ]
}' |
apify call parselab/fda-orange-book-patents-exclusivity-scraper --silent --output-dataset

```

## MCP server setup

```json
{
    "mcpServers": {
        "apify": {
            "type": "http",
            "url": "https://mcp.apify.com/?tools=fetch-actor-details,parselab/fda-orange-book-patents-exclusivity-scraper"
        }
    }
}
```

The hosted server signs you in with OAuth on first connect, so no API token belongs in this config. Clients without OAuth support can send an `Authorization: Bearer <APIFY_API_TOKEN>` header instead, using a token from API & Integrations in Apify Console (https://console.apify.com/settings/integrations).

## OpenAPI specification

Download the OpenAPI definition: https://api.apify.com/v2/actors/tFOT7gGlFheZLuEqM/builds/Itqf72AdrVcApSE5B/openapi.json