Question 1

Is there a generic for Ferumoxytol?

Accepted Answer

Yes. The FDA Orange Book lists 1 approved generic (ANDA) application for Ferumoxytol, referencing the brand FERABRIGHT. Generics rated with an "A" therapeutic-equivalence code are considered substitutable for the brand.

Question 2

What is the reference-listed drug for Ferumoxytol?

Accepted Answer

FERABRIGHT (NDA 219868, AZURITY) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

Does Ferumoxytol have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 2 marketing-exclusivity periods for Ferumoxytol. Exclusivity is granted by FDA at approval (for example new-chemical-entity, orphan-drug, or pediatric exclusivity) and runs independently of any listed patents.

Question 4

What dosage forms of Ferumoxytol are approved?

Accepted Answer

Ferumoxytol is approved in the following dosage form: solution.

Product	Applicant	Application	TE	Approved
FERABRIGHTRLD×2	AZURITY	NDA 219868	—	Oct 16, 2025
FERAHEMERLD	AZURITY	NDA 022180	AB	Jun 30, 2009

Ferumoxytol

Brand (NDA) products · solution

Generic (ANDA) products (1)

Marketing exclusivity (2)

Listed patents

Ferumoxytol — frequently asked questions

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