Orange Book product · Brand (NDA)
NULIBRY
FOSDENOPTERIN HYDROBROMIDE
At a glance
Feb 26, 2021
Approved
Brand (NDA)
Application
Not listed
TE code
1
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Feb 26, 2021
5 yr 5 mo ago
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Feb 26, 2026
4 mo ago
Today
Exclusivity ends · ODE-342
Orphan-drug exclusivity (7 years)
Feb 26, 2028
in 1 yr 9 mo
Patent 7504095 expires
Listed drug product patent expiration.
Apr 09, 2029
in 2 yr 10 mo
Pharmaceutical detail
Active ingredient
FOSDENOPTERIN HYDROBROMIDE
Strength
EQ 9.5MG BASE/VIAL
Dosage form
POWDER
Route
INTRAVENOUS
TE code
Not listed
Application
NDA 214018
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 (2)
- NCENew chemical entity exclusivity (5 years)
Feb 26, 2026
4 mo ago
- ODE-342Orphan-drug exclusivity (7 years)
Feb 26, 2028
in 1 yr 9 mo
Listed patents (1)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7504095 | Apr 09, 2029 | in 2 yr 10 mo | ProductU-3092 |
