FDA Orange Book
Is there a generic for Nuzolvence?
Nuzolvence contains zoliflodacin. 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 Nuzolvence (zoliflodacin). The Orange Book shows its last listed patent expires January 21, 2034 and its last listed exclusivity ends December 12, 2035.
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Nuzolvence products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| for suspension, oral | 3GM/PACKET | Marketed (Rx) | None | 0 | None |
NDA 219491, held by ENTASIS THERAPEUTICS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Nuzolvence patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9040528 | October 13, 2029 | Method of use | U-4369 | 219491 |
| 8658641 | June 20, 2030 | Drug substance | None | 219491 |
| 9839641 | January 21, 2034 | Method of use | U-4369 | 219491 |
| 9540394 | January 21, 2034 | Method of use | U-4369 | 219491 |
| 9187495 | January 21, 2034 | Drug substance | U-4369 | 219491 |
| 8889671 | January 21, 2034 | Drug substance | U-4369 | 219491 |
Nuzolvence exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | December 12, 2030 | 219491 |
| GAIN | Generating Antibiotic Incentives Now | December 12, 2035 | 219491 |
Nuzolvence NDC codes
Questions
Is there a generic for Nuzolvence?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Nuzolvence (zoliflodacin). The Orange Book shows its last listed patent expires January 21, 2034 and its last listed exclusivity ends December 12, 2035.
What is the generic name for Nuzolvence?
The active ingredient in Nuzolvence is zoliflodacin, per the FDA Orange Book.
When does the Nuzolvence patent expire?
The last patent listed for Nuzolvence in the Orange Book expires January 21, 2034. 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.