FDA Orange Book
Is there a generic for Zerbaxa?
Zerbaxa contains ceftolozane and tazobactam. 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 Zerbaxa (ceftolozane and tazobactam). The Orange Book shows its last listed patent expires February 14, 2036 and its last listed exclusivity ends November 12, 2029.
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Zerbaxa products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| powder, intravenous | EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL | Marketed (Rx) | None | 0 | None |
NDA 206829, held by CUBIST PHARMACEUTICALS LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Zerbaxa patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7129232 | May 15, 2028 | Drug substance, Drug product | U-36 | 206829 |
| 7129232 | May 15, 2028 | Drug substance, Drug product | U-1676 | 206829 |
| 7129232 | May 15, 2028 | Drug substance, Drug product | U-3361 | 206829 |
| 7129232 | May 15, 2028 | Drug substance, Drug product | U-3360 | 206829 |
| 7129232 | May 15, 2028 | Drug substance, Drug product | U-4550 | 206829 |
| 7129232 | May 15, 2028 | Drug substance, Drug product | U-4547 | 206829 |
| 7129232 | May 15, 2028 | Drug substance, Drug product | U-4542 | 206829 |
| 7129232 | May 15, 2028 | Drug substance, Drug product | U-4543 | 206829 |
| 7129232*PED | November 15, 2028 | Method of use | None | 206829 |
| 9724353 | September 7, 2032 | Method of use | U-2565 | 206829 |
| 10028963 | September 7, 2032 | Method of use | U-2566 | 206829 |
| 10028963 | September 7, 2032 | Method of use | U-2565 | 206829 |
| 9724353 | September 7, 2032 | Method of use | U-2566 | 206829 |
| 10028963 | September 7, 2032 | Method of use | U-4542 | 206829 |
| 10028963 | September 7, 2032 | Method of use | U-4543 | 206829 |
| 9724353 | September 7, 2032 | Method of use | U-4542 | 206829 |
| 9724353 | September 7, 2032 | Method of use | U-4543 | 206829 |
| 9724353*PED | March 7, 2033 | Method of use | None | 206829 |
| 10028963*PED | March 7, 2033 | Method of use | None | 206829 |
| 8968753 | March 14, 2034 | Method of use | U-1673 | 206829 |
| 8968753 | March 14, 2034 | Method of use | U-1672 | 206829 |
| 10420841 | March 14, 2034 | Method of use | U-2631 | 206829 |
| 10420841 | March 14, 2034 | Method of use | U-1672 | 206829 |
| 11278622 | March 14, 2034 | Method of use | U-3335 | 206829 |
| 11278622 | March 14, 2034 | Method of use | U-3336 | 206829 |
| 10420841 | March 14, 2034 | Method of use | U-3361 | 206829 |
| 10420841 | March 14, 2034 | Method of use | U-3360 | 206829 |
| 8968753 | March 14, 2034 | Method of use | U-3361 | 206829 |
| 8968753 | March 14, 2034 | Method of use | U-3360 | 206829 |
| 11278622 | March 14, 2034 | Method of use | U-4542 | 206829 |
| 11278622 | March 14, 2034 | Method of use | U-4543 | 206829 |
| 10420841 | March 14, 2034 | Method of use | U-4546 | 206829 |
| 10420841 | March 14, 2034 | Method of use | U-4547 | 206829 |
| 8968753 | March 14, 2034 | Method of use | U-4550 | 206829 |
| 8968753 | March 14, 2034 | Method of use | U-4547 | 206829 |
| 9872906 | March 14, 2034 | Drug product | None | 206829 |
| 9320740 | March 14, 2034 | Drug product | None | 206829 |
| 8906898 | May 28, 2034 | Drug substance, Drug product | None | 206829 |
| 10376496 | September 9, 2034 | Method of use | U-2611 | 206829 |
| 10376496 | September 9, 2034 | Method of use | U-2610 | 206829 |
| 10933053 | September 9, 2034 | Method of use | U-3091 | 206829 |
| 10933053 | September 9, 2034 | Method of use | U-3090 | 206829 |
| 10933053 | September 9, 2034 | Method of use | U-4544 | 206829 |
| 10933053 | September 9, 2034 | Method of use | U-4545 | 206829 |
| 10376496 | September 9, 2034 | Method of use | U-4548 | 206829 |
| 10376496 | September 9, 2034 | Method of use | U-4549 | 206829 |
| 8968753*PED | September 14, 2034 | Method of use | None | 206829 |
| 9872906*PED | September 14, 2034 | Method of use | None | 206829 |
| 9320740*PED | September 14, 2034 | Method of use | None | 206829 |
| 10420841*PED | September 14, 2034 | Method of use | None | 206829 |
| 11278622*PED | September 14, 2034 | Method of use | None | 206829 |
| 8906898*PED | November 28, 2034 | Method of use | None | 206829 |
| 10933053*PED | March 9, 2035 | Method of use | None | 206829 |
| 10376496*PED | March 9, 2035 | Method of use | None | 206829 |
| 10125149 | August 14, 2035 | Drug product | None | 206829 |
| 10125149*PED | February 14, 2036 | Method of use | None | 206829 |
Zerbaxa exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NPP | New patient population | May 12, 2029 | 206829 |
| PED | Pediatric exclusivity | November 12, 2029 | 206829 |
Zerbaxa NDC codes
Questions
Is there a generic for Zerbaxa?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Zerbaxa (ceftolozane and tazobactam). The Orange Book shows its last listed patent expires February 14, 2036 and its last listed exclusivity ends November 12, 2029.
What is the generic name for Zerbaxa?
The active ingredient in Zerbaxa is ceftolozane and tazobactam, per the FDA Orange Book.
When does the Zerbaxa patent expire?
The last patent listed for Zerbaxa in the Orange Book expires February 14, 2036. 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.