FDA Orange Book
Is there a generic for Zevtera?
Zevtera contains ceftobiprole medocaril. 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 Zevtera (ceftobiprole medocaril). The Orange Book shows its last listed exclusivity ends April 3, 2034.
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Zevtera products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| powder, intravenous | 667MG/VIAL | Marketed (Rx) | None | 0 | None |
NDA 218275, held by ISTX LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Zevtera exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | April 3, 2029 | 218275 |
| GAIN | Generating Antibiotic Incentives Now | April 3, 2034 | 218275 |
Zevtera NDC codes
Questions
Is there a generic for Zevtera?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Zevtera (ceftobiprole medocaril). The Orange Book shows its last listed exclusivity ends April 3, 2034.
What is the generic name for Zevtera?
The active ingredient in Zevtera is ceftobiprole medocaril, 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.