Tool

Description

orange_book_product_search

Search FDA Orange Book products by ingredient, trade name, applicant, or application number. Returns NDA/ANDA status, therapeutic-equivalence codes, RLD/reference-standard flags, strength, route, and approval date.

orange_book_competition_profile

Profile FDA Orange Book competition for an ingredient or trade name: matched applications/products, NDA versus ANDA holders, RLD/reference standards, patents, and exclusivities. Approved ANDAs indicate regulatory approval, not launch, supply, substitution, or market share.

orange_book_application_detail

Retrieve all FDA Orange Book product, patent, and exclusivity rows for one NDA or ANDA application. Patent and exclusivity dates are FDA listings, not a legal conclusion about enforceability or actual generic entry.

orange_book_patent_expirations

Find listed Orange Book patent expirations in a date window, optionally filtered by drug/applicant through matching product applications. Dates are sponsor-submitted FDA listings and do not establish freedom to operate or a certain launch date.

orange_book_exclusivity_expirations

Find FDA Orange Book exclusivity expirations in a date window, optionally filtered by drug/applicant. Exclusivity codes have program-specific meanings; expiration alone does not guarantee generic approval or launch.

purple_book_product_search

Search FDA Purple Book biologic products by proper/proprietary name, applicant, reference product, or BLA. Returns licensure and product-level attributes. A licensed biosimilar is not necessarily launched, available, interchangeable, or substitutable under state law.

purple_book_competition_profile

Profile FDA-licensed biologic competition around a proper, proprietary, or reference-product name. Counts unique BLAs as sponsors/applications and separates reference products, biosimilars, and interchangeables. It does not measure launches, availability, sales, or market share.

purple_book_biosimilars

List FDA-licensed 351(k) biosimilar and interchangeable products for an optional reference product, applicant, or product name. Approval/licensure does not establish commercial launch or current availability.

purple_book_interchangeables

List FDA Purple Book products designated 351(k) Interchangeable, optionally filtered by reference product, applicant, or product name. Interchangeability is an FDA designation; pharmacy substitution remains subject to applicable law and circumstances.

purple_book_reference_product

Find a reference biologic and its FDA-licensed 351(k) products by proper or proprietary name. Product rows and BLA counts must not be interpreted as market participants, launches, or market share.

purple_book_recent_changes

Return the changes section of FDA’s latest monthly Purple Book report: N=newly approved, R=added in current release, U=updated. Updated or added does not necessarily mean newly licensed.