FDA Orange Book
Is there a generic for Zaynich?
Zaynich contains zidebactam and cefepime. 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 Zaynich (zidebactam and cefepime). The Orange Book shows its last listed patent expires October 12, 2033 and its last listed exclusivity ends May 29, 2036.
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Zaynich products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| powder, intravenous | EQ 2GM BASE/VIAL;1GM/VIAL | Marketed (Rx) | None | 0 | None |
NDA 220787, held by WOCKHARDT BIO AG. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Zaynich patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9132133 | August 24, 2032 | Method of use | U-4558 | 220787 |
| 9827235 | August 24, 2032 | Drug product | U-4558 | 220787 |
| 8853197 | August 24, 2032 | Drug substance | None | 220787 |
| 9381200 | August 24, 2032 | Drug product | None | 220787 |
| 8822450 | August 24, 2032 | Drug substance, Drug product | None | 220787 |
| 9834557 | October 12, 2033 | Drug substance | None | 220787 |
| 9657021 | October 12, 2033 | Drug substance | None | 220787 |
Zaynich exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | May 29, 2031 | 220787 |
| GAIN | Generating Antibiotic Incentives Now | May 29, 2036 | 220787 |
Zaynich NDC codes
Questions
Is there a generic for Zaynich?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Zaynich (zidebactam and cefepime). The Orange Book shows its last listed patent expires October 12, 2033 and its last listed exclusivity ends May 29, 2036.
What is the generic name for Zaynich?
The active ingredient in Zaynich is zidebactam and cefepime, per the FDA Orange Book.
When does the Zaynich patent expire?
The last patent listed for Zaynich in the Orange Book expires October 12, 2033. A listed patent expiry date is not a generic launch date.
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.