The Data Developers
Regulatory

FDA Approved Biologics Registry

All licensed biological products with biosimilar competition tracking, interchangeability status, orphan exclusivity, and reference product linkage. IRA 11-year clock pre-calculated.

4K+ products Monthly Updated 2026-09-01

Overview

All licensed biological products with biosimilar competition tracking, interchangeability status, orphan exclusivity, and reference product linkage. IRA 11-year 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 Purple Book

Freshness

Last refreshed 2026-09-01

Monthly

Coverage

4K+ products

2 delivery tables