Orange Book product · Brand (NDA)
FERRIPROX
DEFERIPRONE
At a glance
Jul 25, 2019
Approved
Brand (NDA)
Application
AB
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 25, 2019
7 yr ago
Today
Exclusivity ends · ODE-417
Orphan-drug exclusivity (7 years)
Apr 30, 2028
in 1 yr 11 mo
Exclusivity ends · ODE-420
Orphan-drug exclusivity (7 years)
Apr 30, 2028
in 1 yr 11 mo
Exclusivity ends · ODE-421
Orphan-drug exclusivity (7 years)
Apr 30, 2028
in 1 yr 11 mo
Pharmaceutical detail
Active ingredient
DEFERIPRONE
Strength
1GM
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
NDA 021825
Product number
002
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
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 (3)
- ODE-417Orphan-drug exclusivity (7 years)
Apr 30, 2028
in 1 yr 11 mo
- ODE-420Orphan-drug exclusivity (7 years)
Apr 30, 2028
in 1 yr 11 mo
- ODE-421Orphan-drug exclusivity (7 years)
Apr 30, 2028
in 1 yr 11 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.
