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Reference answer · Generics & FDA · reviewed quarterly
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Review cadence: quarterlyUnderlying federal data: refreshed weekly to annual per source
Q&A library · Generics & FDA

What is the FDA Orange Book?

The FDA Orange Book — formally the Approved Drug Products with Therapeutic Equivalence Evaluations — is the FDA's official reference for approved drug products, listing every NDA (brand) and ANDA (generic) approval along with therapeutic equivalence ratings, patent information, and exclusivity expirations.

For plan sponsors, the Orange Book is the source of truth for:
- Generic manufacturer count per molecule (predicting pricing power)
- ANDA filing dates and approval velocity (predicting when prices will drop further)
- Patent and exclusivity expiry (predicting when generics can enter the market)
- Therapeutic equivalence ratings (predicting whether substitution is clinically allowed)

The Orange Book updates weekly on Mondays. RxFinder pulls the latest Orange Book file weekly and joins it to NDC-level pricing from NADAC to produce per-drug benchmarks.

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