> ## Documentation Index > Fetch the complete documentation index at: https://docs.pav.bio/llms.txt > Use this file to discover all available pages before exploring further. # FDA records > Orange Book products, patents and exclusivities; Purple Book biologics; orphan designations; warning letters and recalls, linked to companies. ## 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. ```bash cURL theme={null} curl -G https://api.pav.bio/v1/fda \ -H "Authorization: Bearer $PAV_API_KEY" \ --data-urlencode "application_key=N:215866" \ --data-urlencode "record_type=orange_book_patent" \ --data-urlencode "record_type=orange_book_exclusivity" \ --data-urlencode "sort=event_date" \ --data-urlencode "direction=asc" \ --data-urlencode "include_total=true" \ --data-urlencode "limit=3" ``` ```python Python theme={null} import os import requests resp = requests.get( "https://api.pav.bio/v1/fda", headers={"Authorization": f"Bearer {os.environ['PAV_API_KEY']}"}, params={ "application_key": "N:215866", "record_type": ["orange_book_patent", "orange_book_exclusivity"], "sort": "event_date", "direction": "asc", "include_total": "true", "limit": 3, }, ) resp.raise_for_status() body = resp.json() print("total:", body["pagination"]["total"]) for r in body["data"]: print(r["event_date"], "|", r["record_type"], "|", r["title"], "|", r["status"]) ``` ```javascript JavaScript theme={null} const params = new URLSearchParams([ ["application_key", "N:215866"], ["record_type", "orange_book_patent"], ["record_type", "orange_book_exclusivity"], ["sort", "event_date"], ["direction", "asc"], ["include_total", "true"], ["limit", "3"], ]); const resp = await fetch(`https://api.pav.bio/v1/fda?${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); ``` ```json Example response (trimmed) theme={null} { "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`): ```json Example record (trimmed) theme={null} { "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 ```bash cURL theme={null} curl -G https://api.pav.bio/v1/fda \ -H "Authorization: Bearer $PAV_API_KEY" \ --data-urlencode "q=adalimumab" \ --data-urlencode "record_type=purple_book_product" \ --data-urlencode "include_total=true" \ --data-urlencode "limit=3" ``` ```python Python theme={null} import os import requests resp = requests.get( "https://api.pav.bio/v1/fda", headers={"Authorization": f"Bearer {os.environ['PAV_API_KEY']}"}, params={"q": "adalimumab", "record_type": "purple_book_product", "include_total": "true", "limit": 3}, ) resp.raise_for_status() for r in resp.json()["data"]: d = r.get("details", {}) print(r["title"], "|", r["description"], "|", r["fda_organization_name"], "|", d.get("license_type")) ``` ```javascript JavaScript theme={null} const params = new URLSearchParams({ q: "adalimumab", record_type: "purple_book_product", include_total: "true", limit: "3" }); const resp = await fetch(`https://api.pav.bio/v1/fda?${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); ``` ```json Example response (trimmed) theme={null} { "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 ```bash cURL theme={null} curl -G https://api.pav.bio/v1/fda \ -H "Authorization: Bearer $PAV_API_KEY" \ --data-urlencode "company_id=218" \ --data-urlencode "record_type=orphan_designation" \ --data-urlencode "include_total=true" \ --data-urlencode "limit=3" ``` ```python Python theme={null} import os import requests resp = requests.get( "https://api.pav.bio/v1/fda", headers={"Authorization": f"Bearer {os.environ['PAV_API_KEY']}"}, params={"company_id": 218, "record_type": "orphan_designation", "include_total": "true", "limit": 3}, ) resp.raise_for_status() body = resp.json() print("total:", body["pagination"]["total"]) for r in body["data"]: print(r["document_date"], "|", r["designation_id"], "|", r["title"][:40], "|", r["description"]) ``` ```javascript JavaScript theme={null} const params = new URLSearchParams({ company_id: "218", record_type: "orphan_designation", include_total: "true", limit: "3" }); const resp = await fetch(`https://api.pav.bio/v1/fda?${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); ``` ```json Example response (trimmed) theme={null} { "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`. ```bash cURL theme={null} curl -G https://api.pav.bio/v1/fda \ -H "Authorization: Bearer $PAV_API_KEY" \ --data-urlencode "record_type=orange_book_patent" \ --data-urlencode "date_field=event_date" \ --data-urlencode "date_from=2027-01-01" \ --data-urlencode "date_to=2027-03-31" \ --data-urlencode "sort=event_date" \ --data-urlencode "direction=asc" \ --data-urlencode "include_total=true" \ --data-urlencode "limit=3" ``` ```python Python theme={null} import os import requests resp = requests.get( "https://api.pav.bio/v1/fda", headers={"Authorization": f"Bearer {os.environ['PAV_API_KEY']}"}, params={ "record_type": "orange_book_patent", "date_field": "event_date", "date_from": "2027-01-01", "date_to": "2027-03-31", "sort": "event_date", "direction": "asc", "include_total": "true", "limit": 3, }, ) resp.raise_for_status() body = resp.json() print("total:", body["pagination"]["total"]) for r in body["data"]: print(r["event_date"], "|", r["patent_number"], "|", r["title"], "|", r["fda_organization_name"]) ``` ```javascript JavaScript theme={null} const params = new URLSearchParams({ record_type: "orange_book_patent", date_field: "event_date", date_from: "2027-01-01", date_to: "2027-03-31", sort: "event_date", direction: "asc", include_total: "true", limit: "3", }); const resp = await fetch(`https://api.pav.bio/v1/fda?${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`. ```python Python theme={null} 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"]) ``` ```javascript JavaScript theme={null} 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); ``` ```json Example response (trimmed) theme={null} { "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 } } ``` ## Related * [Patent and LOE check guide](/guides/patent-loe-check): combines Orange Book patents and exclusivities with US patent families. * [Patents](/datasets/patents) and [Companies](/datasets/companies)