FDA Orange Book
Is there a generic for Utebzi?
Utebzi contains tebipenem pivoxil. 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 Utebzi (tebipenem pivoxil). The Orange Book shows its last listed patent expires February 6, 2038 and its last listed exclusivity ends June 17, 2036.
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Utebzi products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | EQ 300MG BASE | Marketed (Rx) | None | 0 | None |
NDA 215960, held by GLAXOSMITHKLINE LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Utebzi patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 12226403 | December 15, 2037 | Drug product | U-4569 | 215960 |
| 10889587 | February 6, 2038 | Drug substance, Drug product | U-4570 | 215960 |
Utebzi exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | June 17, 2031 | 215960 |
| GAIN | Generating Antibiotic Incentives Now | June 17, 2036 | 215960 |
Utebzi NDC codes
Questions
Is there a generic for Utebzi?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Utebzi (tebipenem pivoxil). The Orange Book shows its last listed patent expires February 6, 2038 and its last listed exclusivity ends June 17, 2036.
What is the generic name for Utebzi?
The active ingredient in Utebzi is tebipenem pivoxil, per the FDA Orange Book.
When does the Utebzi patent expire?
The last patent listed for Utebzi in the Orange Book expires February 6, 2038. 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.