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RLD / Orange Book Comparator

Follow reference-listed drugs for label, patent, and exclusivity changes without checking the FDA site by hand.

The problem it solves

Reference-listed drug data (patents, exclusivity, label changes) does update on the FDA's own site, but nobody's job is to check it daily — so a generics team finds out about a relevant change only once it's already old news.

How it works

  1. 1Add the reference-listed drugs your generic programs actually track.
  2. 2A scheduled refresh pulls current data directly from openFDA and compares it against what was last recorded.
  3. 3Any real difference is logged as a change event, so the team reviews what changed instead of re-reading the whole record.

Who it’s for

Regulatory affairs staff at generics manufacturers tracking reference-listed drugs.

Is this the same data as the FDA's own Orange Book?

Yes — it's sourced live from openFDA, the FDA's own public API. This tool doesn't hold private data; it watches the public record for you and flags what changed. A no-login version is available to try without an account.

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