FDA Orange Book
Is there a generic for Zycubo?
Zycubo contains copper histidinate. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
No. The Orange Book lists no active FDA-approved generic (ANDA) for Zycubo (copper histidinate). The Orange Book shows its last listed exclusivity ends January 12, 2033.
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Zycubo products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| powder, subcutaneous | 2.9MG/VIAL | Marketed (Rx) | None | 0 | None |
NDA 211241, held by SENTYNL THERAPEUTICS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Zycubo exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | January 12, 2031 | 211241 |
| ODE-520 | Orphan drug exclusivity | January 12, 2033 | 211241 |
Zycubo NDC codes
Questions
Is there a generic for Zycubo?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Zycubo (copper histidinate). The Orange Book shows its last listed exclusivity ends January 12, 2033.
What is the generic name for Zycubo?
The active ingredient in Zycubo is copper histidinate, per the FDA Orange Book.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.