FDA Orange Book · active-ingredient family
Copper histidinate
Copper histidinate is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:ZYCUBO · NDA 211241
1
Brand (NDA)
0
Generics (ANDA)
0
Listed patents
2
Exclusivity periods
Brand (NDA) products · powder
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ZYCUBORLD | SENTYNL THERAPS INC | NDA 211241 | — | Jan 12, 2026 |
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.
Copper histidinate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
