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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 an ANDA?

An ANDA (Abbreviated New Drug Application) is the FDA application a generic drug manufacturer files to bring a generic version of an approved brand drug to market. ANDAs are "abbreviated" because they rely on the safety and efficacy data from the brand drug's original approval — the generic manufacturer only needs to demonstrate bioequivalence, manufacturing quality, and labeling consistency.

ANDA count is the single best predictor of generic market depth:
- 1-3 ANDAs: limited competition, prices often remain near brand
- 5-10 ANDAs: meaningful competition, NADAC drops 60-80% from brand
- 15+ ANDAs: deep competition, NADAC stabilizes at 5-10% of original brand price

ANDA filings are tracked in the FDA Orange Book and updated weekly. Recent rivaroxaban approvals include Apotex (ANDA218427, March 2026), InvaGen Pharmaceuticals (ANDA218768, February 2026), and several others — bringing the total to 58 ANDAs filed.

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