Orange Book product · Brand (NDA)
FERABRIGHT
FERUMOXYTOL
At a glance
Oct 16, 2025
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Oct 16, 2025
8 mo ago
Today
Exclusivity ends · NP
New product exclusivity (3 years)
Oct 16, 2028
in 2 yr 4 mo
Pharmaceutical detail
Active ingredient
FERUMOXYTOL
Strength
EQ 300MG IRON/10ML (EQ 30MG IRON/ML)
Dosage form
SOLUTION
Route
INTRAVENOUS
TE code
Not listed
Application
NDA 219868
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Marketing exclusivity (1)
- NPNew product exclusivity (3 years)
Oct 16, 2028
in 2 yr 4 mo
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
