FDA Orange Book
Is there a generic for Xacduro (copackaged)?
Xacduro (copackaged) contains durlobactam and sulbactam. 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 Xacduro (copackaged) (durlobactam and sulbactam). The Orange Book shows its last listed patent expires November 17, 2035 and its last listed exclusivity ends May 23, 2033.
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Xacduro (copackaged) products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| powder, intravenous | EQ 500MG BASE/VIAL; EQ 500MG BASE/VIAL;EQ 1GM BASE/VIAL | Marketed (Rx) | None | 0 | None |
NDA 216974, 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.
Xacduro (copackaged) patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9623014 | April 2, 2033 | Method of use | U-2840 | 216974 |
| 9309245 | April 2, 2033 | Drug substance | None | 216974 |
| 10376499 | November 17, 2035 | Drug product | U-2840 | 216974 |
| 9968593 | November 17, 2035 | Drug product | U-2840 | 216974 |
Xacduro (copackaged) exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | May 23, 2028 | 216974 |
| GAIN | Generating Antibiotic Incentives Now | May 23, 2033 | 216974 |
Questions
Is there a generic for Xacduro (copackaged)?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Xacduro (copackaged) (durlobactam and sulbactam). The Orange Book shows its last listed patent expires November 17, 2035 and its last listed exclusivity ends May 23, 2033.
What is the generic name for Xacduro (copackaged)?
The active ingredient in Xacduro (copackaged) is durlobactam and sulbactam, per the FDA Orange Book.
When does the Xacduro (copackaged) patent expire?
The last patent listed for Xacduro (copackaged) in the Orange Book expires November 17, 2035. 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.