Skip to main content
  • Dataset id: fda_orange_book
  • Jurisdiction: US · FDA
  • Date field: approval_date. The search’s top-level date_from and date_to filter on it.
  • Access: any API key.

​
Filters

Send these under filters.fda_orange_book in a search request. A filter not listed here, or a value of the wrong type, is a 400. The top-level date_from and date_to set approval_date_from and approval_date_to below, so give a date in one place only.
​
string
BM25 keyword match on the active-ingredient string (uppercase, FDA-canonical). For single-ingredient drugs this is one word (e.g. “SEMAGLUTIDE”); for combos it is semicolon-separated (“AMOXICILLIN; CLAVULANATE POTASSIUM”). This is NOT the marketed brand name — use trade_name for that.
​
string
BM25 keyword match on the brand name (e.g. “OZEMPIC”). NULL on products marketed under the ingredient name.
​
string
BM25 keyword match on the FDA-canonical applicant/holder name (e.g. “NOVO NORDISK”). Prefer the company root over the legal suffix (“INC”, “LP”, “PHARMACEUTICALS LTD”) since BM25 will tokenize either way.
​
string
Exact 6-digit FDA application number (e.g. “209637”). Zero-pad shorter numbers.
​
string
Exact 3-digit FDA product number within an application (e.g. “003”). Only meaningful when combined with appl_no — the same product_no recurs across thousands of applications, so this filter alone matches too broadly.
​
string
Exact application type: “N” = NDA (brand/new drug); “A” = ANDA (generic).Values: N, A.
​
string
BM25 keyword match on the TE Code. Common values: “AB”, “AB1”, “AB2”, “AN”, “AO”, “AP”, “AT” (A-prefix = therapeutically equivalent / substitutable), “BC”, “BD”, “BE”, “BN”, “BP”, “BR”, “BS”, “BT”, “BX” (B-prefix = NOT considered equivalent). NULL when unrated.
​
string
Exact marketing status: “RX” (prescription), “OTC” (over-the-counter), “DISCN” (discontinued).Values: RX, OTC, DISCN.
​
string
Exact license category: “patent” = an Orange Book patent listing; “exclusivity” = an exclusivity grant; “none” = a product with no patent AND no exclusivity in the current Orange Book.Values: patent, exclusivity, none.
​
string
Exact US patent number, digits only (e.g. “8129343”). NULL when license_type != “patent”.
​
string
Exact FDA Patent Use Code (e.g. “U-3355”) identifying a specific method-of-use claim. The same patent can be listed multiple times under different use codes. NULL when license_type != “patent”.
​
string
Exact FDA Exclusivity Code. Examples: “NP” (new product), “NCE” (new chemical entity), “I-961” (new indication), “PED” (pediatric), “GAIN” (antibacterial), “D-193” (orphan or other designation). NULL when license_type != “exclusivity”.
​
string (date)
Inclusive lower bound on the product’s FDA approval date (YYYY-MM-DD). Rows with NULL approval_date (pre-1982 approvals) are excluded by this filter.
​
string (date)
Inclusive upper bound on the product’s FDA approval date (YYYY-MM-DD).
​
string (date)
Inclusive lower bound on the license expiry (license_expire_date = patent_expire OR exclusivity_expire; NULL for license_type=“none”).
​
string (date)
Inclusive upper bound on the license expiry. Use with license_expire_from to find IP expiring in a window (e.g. patents expiring 2027-2029).

​
Fields

Each result from this dataset has these in fields: appl_no, appl_type, applicant_full, approval_date, dosage_form, drug_product_flag, drug_substance_flag, exclusivity_code, exclusivity_expire_date, id, ingredient, is_reference_listed_drug, is_reference_standard, license_expire_date, license_type, marketing_status, patent_delist_requested, patent_expire_date, patent_no, patent_submission_date, patent_use_code, product_no, route, strength, therapeutic_equivalence_code, trade_name, url