FDA records

Overview

FDA records are regulatory records published by the US Food and Drug Administration, with the applicant, sponsor or recipient linked to a Pav company where possible. One endpoint covers seven record types, each with the FDA identifiers you need to join it to other sources: application numbers, product numbers, patent numbers and orphan designation ids. Questions this dataset answers:

Which Orange Book patents and exclusivities protect a drug, and when do they expire?
Which biosimilars of a reference biologic are licensed, and are they interchangeable?
Which orphan designations does a company hold?
Which listed patents expire in the next quarter?
Which warning letters and recalls name a company?

Coverage

Record type (`record_type`)	Records	Source	Linked to a Pav company
`orange_book_product`	48,761	Orange Book, current monthly edition	~68%
`orange_book_patent`	22,303	Orange Book, current monthly edition	Not reported
`orange_book_exclusivity`	2,326	Orange Book, current monthly edition	Not reported
`purple_book_product`	2,242	Purple Book, current monthly edition	Not reported
`orphan_designation`	8,243	FDA orphan drug designations	~74%
`warning_letter`	3,704	FDA warning letters, from 2021	~5%
`recall`	296	FDA recalls, market withdrawals and safety alerts, from 2017	~27%
Total	87,875

Counts are from September 2026. Get current counts with include_total=true and a record_type filter.

Many records, especially warning letters and recalls, are not linked to a Pav company. company_id returns only linked records. To cover a company fully, also search its FDA name with q, for example q=Pfizer.

Record keys change with each FDA edition

Every record has a record_key for GET /v1/fda/{record_key}. Orange Book, Purple Book and orphan-designation keys include the FDA edition and stop working once FDA publishes the next edition. Do not store them. Store the FDA identifier instead and look the record up with a filter:

Record	Stable handle	Filter
Orange Book or Purple Book application	`application_key`, e.g. `N:215866`, `BLA:761059`	`application_key=`
Orange Book or Purple Book product	`product_key`, e.g. `N:215866:019`	`product_key=`
Orange Book patent	`patent_number`	`patent_number=`
Orphan designation	`designation_id`	`designation_id=`
Warning letter, recall	`record_key` (durable)	`GET /v1/fda/{record_key}`

Key fields

Field	Description
`record_key`	Key for `GET /v1/fda/{record_key}`. See above.
`record_type`	One of the seven types in the coverage table.
`source`, `source_version`	FDA publication, and its edition (`YYYY-MM` for Orange and Purple Book; the list date for orphan designations; none for warning letters and recalls).
`fda_organization_name`	Applicant, sponsor or recipient as FDA spells it.
`company`	The linked Pav company (`company_id`, `short_name`, `name`), when linked.
`application_key`, `product_key`, `patent_number`, `designation_id`	FDA identifiers, by record type.
`title`, `description`	Trade name, patent or exclusivity label, subject or brand; and the ingredient, designated indication or subject.
`document_date`	The date FDA issued the record: approval, patent submission, designation, letter or recall. Not set for exclusivities.
`event_date`, `event_date_type`	A dated event: `approval`, `patent_expiry`, `exclusivity_expiry`, `designation`, `issued`, `posted` or `recall`.
`status`	Marketing status for products (`RX`, `OTC`, `DISCN`), `listed` for patents, the exclusivity code for exclusivities, designation status, letter or recall status.
`source_url`	The FDA page for the record, when FDA publishes one.
`details`	Type-specific fields: strength, dosage form and route, TE code, RLD flag; patent use code, substance and product claim flags, pediatric extension; biosimilar pathway and licensure; orphan approval and exclusivity dates; recall reason; letter issuing office.

Endpoints

Endpoint	Use
`GET /v1/fda`	Search and filter FDA records.
`GET /v1/fda/{record_key}`	One record by `record_key`. URL-encode the key: it can contain `/`, `:` and spaces.

Filters

All filters are optional and combine with AND.

Parameter	Matches	Example
`q`	Case-insensitive substring of the title, description, company name, FDA organization name or an FDA identifier. No synonym expansion.	`tirzepatide`
`company_id`	Records linked to these Pav companies. Repeatable.	`218`
`record_type`	Record types. Repeatable.	`orange_book_patent`
`application_key`	Exact FDA application.	`N:215866`
`product_key`	Exact application and product number.	`N:215866:019`
`patent_number`	Exact Orange Book patent number.	`9474780`
`designation_id`	Exact orphan designation id.	`1059424`
`date_field`	Which date `date_from`/`date_to` apply to: `document_date` (default, issue date) or `event_date` (for example a patent or exclusivity expiry).	`event_date`
`date_from`, `date_to`	Date range, inclusive.	`2027-01-01`
`sort`, `direction`	`document_date` (default) or `event_date`; `desc` (default) or `asc`. Missing dates sort last.	`sort=event_date&direction=asc`
`include_total`	Exact match count.	`true`
`limit`, `offset`	Page size (1–100, default 25) and offset.	`limit=100`

Orange Book patents and exclusivities for a drug

Look up the drug’s application, then list its patents and exclusivities. A patent is listed once per product and use code, so the same patent number repeats across rows.

curl -G https://api.pav.bio/v1/fda \
  -H "Authorization: Bearer $PAV_API_KEY" \
  --data-urlencode "application_key=N:215866" \
  --data-urlencode "record_type=orange_book_patent" \
  --data-urlencode "record_type=orange_book_exclusivity" \
  --data-urlencode "sort=event_date" \
  --data-urlencode "direction=asc" \
  --data-urlencode "include_total=true" \
  --data-urlencode "limit=3"

import os
import requests

resp = requests.get(
    "https://api.pav.bio/v1/fda",
    headers={"Authorization": f"Bearer {os.environ['PAV_API_KEY']}"},
    params={
        "application_key": "N:215866",
        "record_type": ["orange_book_patent", "orange_book_exclusivity"],
        "sort": "event_date",
        "direction": "asc",
        "include_total": "true",
        "limit": 3,
    },
)
resp.raise_for_status()
body = resp.json()
print("total:", body["pagination"]["total"])
for r in body["data"]:
    print(r["event_date"], "|", r["record_type"], "|", r["title"], "|", r["status"])

const params = new URLSearchParams([
  ["application_key", "N:215866"],
  ["record_type", "orange_book_patent"],
  ["record_type", "orange_book_exclusivity"],
  ["sort", "event_date"],
  ["direction", "asc"],
  ["include_total", "true"],
  ["limit", "3"],
]);
const resp = await fetch(`https://api.pav.bio/v1/fda?${params}`, {
  headers: { Authorization: `Bearer ${process.env.PAV_API_KEY}` },
});
const body = await resp.json();
console.log("total:", body.pagination.total);
for (const r of body.data) console.log(r.event_date, "|", r.record_type, "|", r.title, "|", r.status);

Example response (trimmed)

{
  "data": [
    {
      "record_key": "orange_book_exclusivity:2026-08:N:215866:001:NCE:May 13, 2027",
      "record_type": "orange_book_exclusivity",
      "source_version": "2026-08",
      "fda_organization_name": "ELI LILLY AND CO",
      "company": { "company_id": 218, "short_name": "eli_lilly", "name": "Eli Lilly" },
      "application_key": "N:215866",
      "product_key": "N:215866:001",
      "title": "MOUNJARO (AUTOINJECTOR) — Exclusivity NCE",
      "description": "TIRZEPATIDE",
      "event_date": "2027-05-13",
      "event_date_type": "exclusivity_expiry",
      "status": "NCE"
    }
  ],
  "pagination": { "limit": 3, "offset": 0, "total": 522 }
}

A listed patent row from the same application (patent_number=9474780):

Example record (trimmed)

{
  "record_key": "orange_book_patent:2026-08:N:215866:018:9474780:U-4374",
  "record_type": "orange_book_patent",
  "application_key": "N:215866",
  "product_key": "N:215866:018",
  "patent_number": "9474780",
  "title": "MOUNJARO — Patent 9474780",
  "description": "TIRZEPATIDE",
  "document_date": "2026-02-20",
  "event_date": "2036-05-13",
  "event_date_type": "patent_expiry",
  "status": "listed",
  "details": {
    "patent_use_code": "U-4374",
    "pediatric_extension": false,
    "drug_substance_claim": true,
    "drug_product_claim": true
  }
}

Biosimilars of a reference biologic

curl -G https://api.pav.bio/v1/fda \
  -H "Authorization: Bearer $PAV_API_KEY" \
  --data-urlencode "q=adalimumab" \
  --data-urlencode "record_type=purple_book_product" \
  --data-urlencode "include_total=true" \
  --data-urlencode "limit=3"

import os
import requests

resp = requests.get(
    "https://api.pav.bio/v1/fda",
    headers={"Authorization": f"Bearer {os.environ['PAV_API_KEY']}"},
    params={"q": "adalimumab", "record_type": "purple_book_product", "include_total": "true", "limit": 3},
)
resp.raise_for_status()
for r in resp.json()["data"]:
    d = r.get("details", {})
    print(r["title"], "|", r["description"], "|", r["fda_organization_name"], "|", d.get("license_type"))

const params = new URLSearchParams({ q: "adalimumab", record_type: "purple_book_product", include_total: "true", limit: "3" });
const resp = await fetch(`https://api.pav.bio/v1/fda?${params}`, {
  headers: { Authorization: `Bearer ${process.env.PAV_API_KEY}` },
});
const { data } = await resp.json();
for (const r of data) console.log(r.title, "|", r.description, "|", r.fda_organization_name, "|", r.details?.license_type);

Example response (trimmed)

{
  "data": [
    {
      "record_type": "purple_book_product",
      "source_version": "2026-08",
      "fda_organization_name": "Samsung Bioepis Co., Ltd.",
      "company": { "company_id": 1450, "short_name": "samsung_bioepis", "name": "Samsung Bioepis Co., Ltd." },
      "application_key": "BLA:761059",
      "product_key": "BLA:761059:006",
      "title": "Hadlima",
      "description": "adalimumab-bwwd",
      "document_date": "2026-04-29",
      "event_date_type": "approval",
      "status": "Rx",
      "details": {
        "strength": "80MG/0.8ML",
        "dosage_form": "Injection",
        "route": "Subcutaneous",
        "license_type": "351(k) Interchangeable",
        "licensure": "Licensed"
      }
    }
  ],
  "pagination": { "limit": 3, "offset": 0, "total": 66 }
}

A company’s orphan designations

curl -G https://api.pav.bio/v1/fda \
  -H "Authorization: Bearer $PAV_API_KEY" \
  --data-urlencode "company_id=218" \
  --data-urlencode "record_type=orphan_designation" \
  --data-urlencode "include_total=true" \
  --data-urlencode "limit=3"

import os
import requests

resp = requests.get(
    "https://api.pav.bio/v1/fda",
    headers={"Authorization": f"Bearer {os.environ['PAV_API_KEY']}"},
    params={"company_id": 218, "record_type": "orphan_designation", "include_total": "true", "limit": 3},
)
resp.raise_for_status()
body = resp.json()
print("total:", body["pagination"]["total"])
for r in body["data"]:
    print(r["document_date"], "|", r["designation_id"], "|", r["title"][:40], "|", r["description"])

const params = new URLSearchParams({ company_id: "218", record_type: "orphan_designation", include_total: "true", limit: "3" });
const resp = await fetch(`https://api.pav.bio/v1/fda?${params}`, {
  headers: { Authorization: `Bearer ${process.env.PAV_API_KEY}` },
});
const body = await resp.json();
console.log("total:", body.pagination.total);
for (const r of body.data) console.log(r.document_date, "|", r.designation_id, "|", r.title.slice(0, 40), "|", r.description);

Example response (trimmed)

{
  "data": [
    {
      "record_type": "orphan_designation",
      "source_version": "2026-09-26",
      "fda_organization_name": "Eli Lilly and Company",
      "company": { "company_id": 218, "short_name": "eli_lilly", "name": "Eli Lilly" },
      "designation_id": "1083025",
      "title": "pirtobrutinib",
      "description": "treatment of primary immune thrombocytopenia",
      "document_date": "2026-08-22",
      "event_date_type": "designation",
      "status": "Designated",
      "source_url": "https://www.accessdata.fda.gov/scripts/opdlisting/oopd/"
    }
  ],
  "pagination": { "limit": 3, "offset": 0, "total": 30 }
}

Patents expiring in a window

Exclusivities and patent expiries live in event_date, so set date_field=event_date.

curl -G https://api.pav.bio/v1/fda \
  -H "Authorization: Bearer $PAV_API_KEY" \
  --data-urlencode "record_type=orange_book_patent" \
  --data-urlencode "date_field=event_date" \
  --data-urlencode "date_from=2027-01-01" \
  --data-urlencode "date_to=2027-03-31" \
  --data-urlencode "sort=event_date" \
  --data-urlencode "direction=asc" \
  --data-urlencode "include_total=true" \
  --data-urlencode "limit=3"

import os
import requests

resp = requests.get(
    "https://api.pav.bio/v1/fda",
    headers={"Authorization": f"Bearer {os.environ['PAV_API_KEY']}"},
    params={
        "record_type": "orange_book_patent",
        "date_field": "event_date",
        "date_from": "2027-01-01",
        "date_to": "2027-03-31",
        "sort": "event_date",
        "direction": "asc",
        "include_total": "true",
        "limit": 3,
    },
)
resp.raise_for_status()
body = resp.json()
print("total:", body["pagination"]["total"])
for r in body["data"]:
    print(r["event_date"], "|", r["patent_number"], "|", r["title"], "|", r["fda_organization_name"])

const params = new URLSearchParams({
  record_type: "orange_book_patent",
  date_field: "event_date",
  date_from: "2027-01-01",
  date_to: "2027-03-31",
  sort: "event_date",
  direction: "asc",
  include_total: "true",
  limit: "3",
});
const resp = await fetch(`https://api.pav.bio/v1/fda?${params}`, {
  headers: { Authorization: `Bearer ${process.env.PAV_API_KEY}` },
});
const body = await resp.json();
console.log("total:", body.pagination.total);
for (const r of body.data) console.log(r.event_date, "|", r.patent_number, "|", r.title, "|", r.fda_organization_name);

Get one record

URL-encode the record_key.

import os
from urllib.parse import quote

import requests

key = "orange_book_product:2026-08:N:215866:019"
resp = requests.get(
    f"https://api.pav.bio/v1/fda/{quote(key, safe='')}",
    headers={"Authorization": f"Bearer {os.environ['PAV_API_KEY']}"},
)
if resp.status_code == 404:
    # Keys that carry an FDA edition expire; re-find the record by its FDA identifier.
    resp = requests.get(
        "https://api.pav.bio/v1/fda",
        headers={"Authorization": f"Bearer {os.environ['PAV_API_KEY']}"},
        params={"product_key": "N:215866:019", "record_type": "orange_book_product"},
    )
    resp.raise_for_status()
    record = resp.json()["data"][0]
else:
    resp.raise_for_status()
    record = resp.json()
print(record["title"], "|", record["details"]["strength"], "|", record["status"])

const key = "orange_book_product:2026-08:N:215866:019";
const headers = { Authorization: `Bearer ${process.env.PAV_API_KEY}` };
let resp = await fetch(`https://api.pav.bio/v1/fda/${encodeURIComponent(key)}`, { headers });
let record;
if (resp.status === 404) {
  // Keys that carry an FDA edition expire; re-find the record by its FDA identifier.
  const params = new URLSearchParams({ product_key: "N:215866:019", record_type: "orange_book_product" });
  resp = await fetch(`https://api.pav.bio/v1/fda?${params}`, { headers });
  record = (await resp.json()).data[0];
} else {
  record = await resp.json();
}
console.log(record.title, "|", record.details.strength, "|", record.status);

Example response (trimmed)

{
  "record_key": "orange_book_product:2026-08:N:215866:019",
  "record_type": "orange_book_product",
  "source": "orange_book",
  "source_version": "2026-08",
  "fda_organization_name": "ELI LILLY AND CO",
  "company": { "company_id": 218, "short_name": "eli_lilly", "name": "Eli Lilly" },
  "application_key": "N:215866",
  "product_key": "N:215866:019",
  "title": "MOUNJARO KWIKPEN",
  "description": "TIRZEPATIDE",
  "document_date": "2026-01-20",
  "event_date_type": "approval",
  "status": "RX",
  "details": {
    "ingredient": "TIRZEPATIDE",
    "strength": "10MG/2.4ML (4.17MG/ML)",
    "dosage_route": "SOLUTION;SUBCUTANEOUS",
    "reference_listed_drug": true,
    "reference_standard": true
  }
}

Patent and LOE check guide: combines Orange Book patents and exclusivities with US patent families.
Patents and Companies

Get started

Datasets

Working with the API

Integrations

Guides

Overview

Coverage

Record keys change with each FDA edition

Key fields

Endpoints

Filters

Orange Book patents and exclusivities for a drug

Biosimilars of a reference biologic

A company’s orphan designations

Patents expiring in a window

Get one record

​Overview

​Coverage

​Record keys change with each FDA edition

​Key fields

​Endpoints

​Filters

​Orange Book patents and exclusivities for a drug

​Biosimilars of a reference biologic

​A company’s orphan designations

​Patents expiring in a window

​Get one record

​Related

Overview

Coverage

Record keys change with each FDA edition

Key fields

Endpoints

Filters

Orange Book patents and exclusivities for a drug

Biosimilars of a reference biologic

A company’s orphan designations

Patents expiring in a window

Get one record

Related