Pricing

from $100.00 / 1,000 biologic records

FDA Purple Book — Biologics & Biosimilars API

Search the FDA Purple Book: licensed biologics, biosimilars, and interchangeables with reference-product linkage and exclusivity-expiry dates that signal when biosimilar competition can begin. For biosimilar developers, pharma investors, and IP/regulatory teams.

Pricing

from $100.00 / 1,000 biologic records

Rating

0.0

(0)

Developer

NexGenData

Actor stats

Bookmarked

Total users

Monthly active users

3 days ago

Last modified

Categories

Business

You can access the FDA Purple Book — Biologics & Biosimilars API programmatically from your own applications by using the Apify API. You can also choose the language preference from below. To use the Apify API, you’ll need an Apify account and your API token, found in Integrations settings in Apify Console.

Python

JavaScript

CLI

OpenAPI

HTTP

MCP

{
  "openapi": "3.0.1",
  "info": {
    "version": "0.0",
    "x-build-id": "GYq0eKiJSQOdVwEaN"
  },
  "servers": [
    {
      "url": "https://api.apify.com/v2"
    }
  ],
  "paths": {
    "/acts/nexgendata~fda-purple-book-biologics-biosimilars/run-sync-get-dataset-items": {
      "post": {
        "operationId": "run-sync-get-dataset-items-nexgendata-fda-purple-book-biologics-biosimilars",
        "x-openai-isConsequential": false,
        "summary": "Executes an Actor, waits for its completion, and returns Actor's dataset items in response.",
        "tags": [
          "Run Actor"
        ],
        "requestBody": {
          "required": true,
          "content": {
            "application/json": {
              "schema": {
                "$ref": "#/components/schemas/inputSchema"
              }
            }
          }
        },
        "parameters": [
          {
            "name": "token",
            "in": "query",
            "required": true,
            "schema": {
              "type": "string"
            },
            "description": "Enter your Apify token here"
          }
        ],
        "responses": {
          "200": {
            "description": "OK"
          }
        }
      }
    },
    "/acts/nexgendata~fda-purple-book-biologics-biosimilars/runs": {
      "post": {
        "operationId": "runs-sync-nexgendata-fda-purple-book-biologics-biosimilars",
        "x-openai-isConsequential": false,
        "summary": "Executes an Actor and returns information about the initiated run in response.",
        "tags": [
          "Run Actor"
        ],
        "requestBody": {
          "required": true,
          "content": {
            "application/json": {
              "schema": {
                "$ref": "#/components/schemas/inputSchema"
              }
            }
          }
        },
        "parameters": [
          {
            "name": "token",
            "in": "query",
            "required": true,
            "schema": {
              "type": "string"
            },
            "description": "Enter your Apify token here"
          }
        ],
        "responses": {
          "200": {
            "description": "OK",
            "content": {
              "application/json": {
                "schema": {
                  "$ref": "#/components/schemas/runsResponseSchema"
                }
              }
            }
          }
        }
      }
    },
    "/acts/nexgendata~fda-purple-book-biologics-biosimilars/run-sync": {
      "post": {
        "operationId": "run-sync-nexgendata-fda-purple-book-biologics-biosimilars",
        "x-openai-isConsequential": false,
        "summary": "Executes an Actor, waits for completion, and returns the OUTPUT from Key-value store in response.",
        "tags": [
          "Run Actor"
        ],
        "requestBody": {
          "required": true,
          "content": {
            "application/json": {
              "schema": {
                "$ref": "#/components/schemas/inputSchema"
              }
            }
          }
        },
        "parameters": [
          {
            "name": "token",
            "in": "query",
            "required": true,
            "schema": {
              "type": "string"
            },
            "description": "Enter your Apify token here"
          }
        ],
        "responses": {
          "200": {
            "description": "OK"
          }
        }
      }
    }
  },
  "components": {
    "schemas": {
      "inputSchema": {
        "type": "object",
        "properties": {
          "properName": {
            "title": "Proper (nonproprietary) name",
            "type": "string",
            "description": "Active substance / nonproprietary name, contains match (e.g. 'adalimumab')."
          },
          "proprietaryName": {
            "title": "Proprietary (brand) name",
            "type": "string",
            "description": "Brand name, contains match (e.g. 'Humira', 'Hadlima')."
          },
          "applicant": {
            "title": "Applicant / company",
            "type": "string",
            "description": "Sponsoring company, contains match."
          },
          "blaNumber": {
            "title": "BLA number",
            "type": "string",
            "description": "Exact Biologics License Application number."
          },
          "referenceProduct": {
            "title": "Reference product",
            "type": "string",
            "description": "Find biosimilars of this reference biologic (matches reference proper/brand name)."
          },
          "licenseType": {
            "title": "License type",
            "type": "array",
            "description": "351(a) = reference biologic; 351(k) Biosimilar; 351(k) Interchangeable.",
            "items": {
              "type": "string",
              "enum": [
                "351(a)",
                "351(k) Biosimilar",
                "351(k) Interchangeable"
              ]
            }
          },
          "onlyBiosimilars": {
            "title": "Only biosimilars/interchangeables",
            "type": "boolean",
            "description": "Return only 351(k) products (biosimilars and interchangeables).",
            "default": false
          },
          "exclusivityExpiringAfter": {
            "title": "Exclusivity expiring after",
            "type": "string",
            "description": "Keep products whose exclusivity expires on/after this date (YYYY-MM-DD)."
          },
          "exclusivityExpiringBefore": {
            "title": "Exclusivity expiring before",
            "type": "string",
            "description": "Keep products whose exclusivity expires on/before this date (YYYY-MM-DD). Useful for near-term biosimilar opportunities."
          },
          "maxResults": {
            "title": "Max results",
            "minimum": 1,
            "maximum": 10000,
            "type": "integer",
            "description": "Maximum number of product records to return.",
            "default": 3000
          }
        }
      },
      "runsResponseSchema": {
        "type": "object",
        "properties": {
          "data": {
            "type": "object",
            "properties": {
              "id": {
                "type": "string"
              },
              "actId": {
                "type": "string"
              },
              "userId": {
                "type": "string"
              },
              "startedAt": {
                "type": "string",
                "format": "date-time",
                "example": "2025-01-08T00:00:00.000Z"
              },
              "finishedAt": {
                "type": "string",
                "format": "date-time",
                "example": "2025-01-08T00:00:00.000Z"
              },
              "status": {
                "type": "string",
                "example": "READY"
              },
              "meta": {
                "type": "object",
                "properties": {
                  "origin": {
                    "type": "string",
                    "example": "API"
                  },
                  "userAgent": {
                    "type": "string"
                  }
                }
              },
              "stats": {
                "type": "object",
                "properties": {
                  "inputBodyLen": {
                    "type": "integer",
                    "example": 2000
                  },
                  "rebootCount": {
                    "type": "integer",
                    "example": 0
                  },
                  "restartCount": {
                    "type": "integer",
                    "example": 0
                  },
                  "resurrectCount": {
                    "type": "integer",
                    "example": 0
                  },
                  "computeUnits": {
                    "type": "integer",
                    "example": 0
                  }
                }
              },
              "options": {
                "type": "object",
                "properties": {
                  "build": {
                    "type": "string",
                    "example": "latest"
                  },
                  "timeoutSecs": {
                    "type": "integer",
                    "example": 300
                  },
                  "memoryMbytes": {
                    "type": "integer",
                    "example": 1024
                  },
                  "diskMbytes": {
                    "type": "integer",
                    "example": 2048
                  }
                }
              },
              "buildId": {
                "type": "string"
              },
              "defaultKeyValueStoreId": {
                "type": "string"
              },
              "defaultDatasetId": {
                "type": "string"
              },
              "defaultRequestQueueId": {
                "type": "string"
              },
              "buildNumber": {
                "type": "string",
                "example": "1.0.0"
              },
              "containerUrl": {
                "type": "string"
              },
              "usage": {
                "type": "object",
                "properties": {
                  "ACTOR_COMPUTE_UNITS": {
                    "type": "integer",
                    "example": 0
                  },
                  "DATASET_READS": {
                    "type": "integer",
                    "example": 0
                  },
                  "DATASET_WRITES": {
                    "type": "integer",
                    "example": 0
                  },
                  "KEY_VALUE_STORE_READS": {
                    "type": "integer",
                    "example": 0
                  },
                  "KEY_VALUE_STORE_WRITES": {
                    "type": "integer",
                    "example": 1
                  },
                  "KEY_VALUE_STORE_LISTS": {
                    "type": "integer",
                    "example": 0
                  },
                  "REQUEST_QUEUE_READS": {
                    "type": "integer",
                    "example": 0
                  },
                  "REQUEST_QUEUE_WRITES": {
                    "type": "integer",
                    "example": 0
                  },
                  "DATA_TRANSFER_INTERNAL_GBYTES": {
                    "type": "integer",
                    "example": 0
                  },
                  "DATA_TRANSFER_EXTERNAL_GBYTES": {
                    "type": "integer",
                    "example": 0
                  },
                  "PROXY_RESIDENTIAL_TRANSFER_GBYTES": {
                    "type": "integer",
                    "example": 0
                  },
                  "PROXY_SERPS": {
                    "type": "integer",
                    "example": 0
                  }
                }
              },
              "usageTotalUsd": {
                "type": "number",
                "example": 0.00005
              },
              "usageUsd": {
                "type": "object",
                "properties": {
                  "ACTOR_COMPUTE_UNITS": {
                    "type": "integer",
                    "example": 0
                  },
                  "DATASET_READS": {
                    "type": "integer",
                    "example": 0
                  },
                  "DATASET_WRITES": {
                    "type": "integer",
                    "example": 0
                  },
                  "KEY_VALUE_STORE_READS": {
                    "type": "integer",
                    "example": 0
                  },
                  "KEY_VALUE_STORE_WRITES": {
                    "type": "number",
                    "example": 0.00005
                  },
                  "KEY_VALUE_STORE_LISTS": {
                    "type": "integer",
                    "example": 0
                  },
                  "REQUEST_QUEUE_READS": {
                    "type": "integer",
                    "example": 0
                  },
                  "REQUEST_QUEUE_WRITES": {
                    "type": "integer",
                    "example": 0
                  },
                  "DATA_TRANSFER_INTERNAL_GBYTES": {
                    "type": "integer",
                    "example": 0
                  },
                  "DATA_TRANSFER_EXTERNAL_GBYTES": {
                    "type": "integer",
                    "example": 0
                  },
                  "PROXY_RESIDENTIAL_TRANSFER_GBYTES": {
                    "type": "integer",
                    "example": 0
                  },
                  "PROXY_SERPS": {
                    "type": "integer",
                    "example": 0
                  }
                }
              }
            }
          }
        }
      }
    }
  }
}

FDA Purple Book API — Biologics & Biosimilars Tracker OpenAPI definition

OpenAPI is a standard for designing and describing RESTful APIs, allowing developers to define API structure, endpoints, and data formats in a machine-readable way. It simplifies API development, integration, and documentation.

OpenAPI is effective when used with AI agents and GPTs by standardizing how these systems interact with various APIs, for reliable integrations and efficient communication.

By defining machine-readable API specifications, OpenAPI allows AI models like GPTs to understand and use varied data sources, improving accuracy. This accelerates development, reduces errors, and provides context-aware responses, making OpenAPI a core component for AI applications.

You can download the OpenAPI definitions for FDA Purple Book — Biologics & Biosimilars API from the options below:

OpenAPI.json

If you’d like to learn more about how OpenAPI powers GPTs, read our blog post.

You can also check out our other API clients:

FDA Purple Book — Biologics & Biosimilars API API in Python

FDA Purple Book — Biologics & Biosimilars API API in JavaScript

FDA Purple Book — Biologics & Biosimilars API API through CLI

FDA Purple Book — Biologics & Biosimilars API API

FDA Orange Book — Drug Patent & Exclusivity API

nexgendata/fda-orange-book-drug-patents

Track FDA Orange Book drug patents and exclusivity data. Clean JSON for IP counsel, brand teams and AI agents.

NexGenData

FDA Orange Book Scraper

automation-lab/fda-orange-book-scraper

Search public FDA Orange Book / Drugs@FDA records by brand, generic, ingredient, sponsor, or application number for pharma research.

Stas Persiianenko

Book API

vivid_astronaut/book

Fabio Suizu

FDA Recalls Database Scraper

crawlergang/fda-recalls-scraper

Scrape FDA recalls from the openFDA REST API. Search food, drug, device, biologics, cosmetics, and veterinary recalls by keyword, product type, firm name, or classification. No API key required.

Crawler Gang

5.0

FDA Recalls Database Scraper

crawlerbros/fda-recalls-scraper

Scrape FDA recalls from the openFDA REST API. Search food, drug, device, biologics, cosmetics, and veterinary recalls by keyword, product type, firm name, or classification. No API key required.

Crawler Bros

FDA Orange Book Scraper

labrat011/fda-orange-book-scraper

Extract FDA Orange Book data — drug patent expirations, exclusivity periods, generic equivalents, and therapeutic equivalence ratings. No API key required.

mick_

FDA Orange Book Patent & Exclusivity Tracker — Quarterly Diff

changewire/fda-orange-book-extraction

Purpose-built FDA Orange Book diff stream — NDA/ANDA/BLA patent listings, exclusivity grants, LoE + TE-code shifts as JSONL. FDA-vocabulary-aware vs general-purpose scrapers like Browse AI; per-record metered vs Cortellis $35-50k/yr seat tax for pharma BI + IP + generics. Public runs.

ChangeWire

FDA Orange Book Exclusivity Cliff Watcher

zentrafoundry/fda-orange-book-exclusivity-cliff-watcher

Track upcoming patent and exclusivity expiries for product families, active ingredients, applicants, and application numbers.

Zentra

Priori Drug Patent Loss-of-Exclusivity (LOE) Calendar

priori_intelligence/priori-drug-loss-of-exclusivity-calendar

FDA Orange Book drug patent and exclusivity intelligence: latest patent expiry, exclusivity windows, and a computed loss-of-exclusivity date by drug or company.

Greg Newkirk

FDA Orange Book Scraper

parseforge/fda-orange-book-scraper

Scrape the FDA Orange Book of approved drug products with therapeutic equivalence evaluations. Get NDA, ingredient, dosage form, strength, route, applicant, marketing status, TE code, RLD/RS flags, exclusivity and patent data. Perfect for pharma research, payers, and generics intelligence.