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.