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Drugs & devicesSource-backed product

FDA Orange Book

The current FDA Orange Book (October 2026): approved drug products with their patents, exclusivity periods and therapeutic-equivalence ratings, used to work out when a brand drug's protections lapse. History is a set of irregular snapshots since March 2021 (with gaps, such as August 2023 to October 2024), not a continuous series. Patent and exclusivity dates are text in varying formats.

What Vlada adds: Preserves the publisher data, normalizes schema eras and identifiers, and connects the product to compatible healthcare entities with measured join coverage.

current rows
73.6K
current rows
datasets
3
datasets
cadence
monthly
cadence
coverage
current; snapshots 2021-2026
coverage

Publishers: U.S. Food and Drug Administration

What's inside

FDA Orange Book (patents + exclusivity)
FDA approved-drug products with therapeutic-equivalence, patent, and exclusivity metadata.
grain: One row per (application_number, product_id, observed_month).
48.9K rows
FDA Orange Book — patents
FDA Orange Book patent listings — patents protecting approved drugs by application/product, with patent number, use code, expiry, and substance/product flags.
grain: One row per (application, product, patent) — Orange Book patent listing.
22.3K rows
FDA Orange Book — exclusivity
FDA Orange Book exclusivity periods by application/product — exclusivity code and expiry.
grain: One row per (application, product, exclusivity_code) — market exclusivity.
2.3K rows