Small-molecule approval, patent, exclusivity, and IRA timing
Regulatory teams use this context to reconstruct product history without parsing authority-specific files.
All FDA-approved small molecules with patent listings, exclusivity codes, therapeutic equivalence ratings, and IRA 7-year eligibility clock pre-calculated.
Request context access
Ask us to provision this analytical context into your BigQuery or Snowflake workspace.
Request AccessRelated context
Overview
Regulatory teams use this context to reconstruct product history without parsing authority-specific files.
All FDA-approved small molecules with patent listings, exclusivity codes, therapeutic equivalence ratings, and IRA 7-year eligibility clock pre-calculated.
Analyze approval, label, safety, REMS, biologic, small molecule, and NDC records without source-specific parsing work.
Join NDA, BLA, NDC, RxCUI, UNII, SPL set ID, patent, and exclusivity identifiers through the drug identity spine.
Model regulatory timelines, indication expansion, label change velocity, and eligibility clocks with curated fields.
Trace every normalized attribute back to the official FDA or NLM source authority.
Source authority
FDA Orange Book
Freshness
Last refreshed 2026-09-01
Monthly
Coverage
40K+ products
2 delivery tables