Listed patent runway and challenge context
Portfolio and BD teams use this context to model protection runway, challenge pressure, and loss-of-exclusivity timing.
FDA-listed drug patents from the Orange Book with expiry dates, drug substance vs. method-of-use classification, Paragraph IV challenge status, and delist flags.
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Overview
Portfolio and BD teams use this context to model protection runway, challenge pressure, and loss-of-exclusivity timing.
FDA-listed drug patents from the Orange Book with expiry dates, drug substance vs. method-of-use classification, Paragraph IV challenge status, and delist flags.
Build patent cliff and loss-of-exclusivity timelines using normalized patent, exclusivity, and approval identifiers.
Compare FDA-listed patents with USPTO metadata, assignee networks, and forward citation context.
Separate substance, product, and method-of-use protection when modeling generic or biosimilar entry.
Join IP records to revenue, labels, clinical stage, and target biology through the drug identity spine.
Source authority
FDA Orange Book Patents
Freshness
Last refreshed 2026-09-01
Monthly
Coverage
15K+ patents
2 delivery tables