FDA Orange Book
Is there a generic for Blujepa?
Blujepa contains gepotidacin. 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 Blujepa (gepotidacin). The Orange Book shows its last listed patent expires December 13, 2042 and its last listed exclusivity ends March 25, 2035.
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Blujepa products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | EQ 750MG BASE | Marketed (Rx) | None | 0 | None |
NDA 218230, held by GLAXOSMITHKLINE LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Blujepa patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8389524 | February 12, 2029 | Drug substance, Drug product | U-4166 | 218230 |
| 10702521 | August 20, 2035 | Method of use | U-4361 | 218230 |
| 11229646 | August 20, 2035 | Method of use | U-4361 | 218230 |
| 12528809 | December 13, 2042 | Drug substance, Drug product | U-4361 | 218230 |
| 12528809 | December 13, 2042 | Drug substance, Drug product | U-4408 | 218230 |
Blujepa exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| I-978 | New indication | December 11, 2028 | 218230 |
| NCE | New chemical entity | March 25, 2030 | 218230 |
| GAIN | Generating Antibiotic Incentives Now | March 25, 2035 | 218230 |
Blujepa NDC codes
Questions
Is there a generic for Blujepa?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Blujepa (gepotidacin). The Orange Book shows its last listed patent expires December 13, 2042 and its last listed exclusivity ends March 25, 2035.
What is the generic name for Blujepa?
The active ingredient in Blujepa is gepotidacin, per the FDA Orange Book.
When does the Blujepa patent expire?
The last patent listed for Blujepa in the Orange Book expires December 13, 2042. 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.