Orange Book product · Brand (NDA)
ZYCUBO
COPPER HISTIDINATE
At a glance
Jan 12, 2026
Approved
Brand (NDA)
Application
Not listed
TE code
None
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jan 12, 2026
5 mo ago
Today
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Jan 12, 2031
in 4 yr 8 mo
Exclusivity ends · ODE-520
Orphan-drug exclusivity (7 years)
Jan 12, 2033
in 6 yr 8 mo
Pharmaceutical detail
Active ingredient
COPPER HISTIDINATE
Strength
2.9MG/VIAL
Dosage form
POWDER
Route
SUBCUTANEOUS
TE code
Not listed
Application
NDA 211241
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)
Jan 12, 2031
in 4 yr 8 mo
- ODE-520Orphan-drug exclusivity (7 years)
Jan 12, 2033
in 6 yr 8 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.
