FDA Orange Book
Is there a generic for Brexafemme?
Brexafemme contains ibrexafungerp. 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 Brexafemme (ibrexafungerp). The Orange Book shows its last listed patent expires June 10, 2039 and its last listed exclusivity ends June 1, 2031.
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Brexafemme products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | EQ 150MG BASE | Marketed (Rx) | None | 0 | None |
NDA 214900, held by GLAXOSMITHKLINE LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Brexafemme patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8188085 | August 28, 2030 | Drug substance, Drug product | U-3159 | 214900 |
| 10370406 | January 19, 2035 | Method of use | U-3159 | 214900 |
| 10927142 | January 19, 2035 | Drug substance | None | 214900 |
| 10174074 | January 19, 2035 | Drug substance, Drug product | None | 214900 |
| 11534433 | June 10, 2039 | Method of use | U-3159 | 214900 |
| 11534433 | June 10, 2039 | Method of use | U-3508 | 214900 |
Brexafemme exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | June 1, 2026 | 214900 |
| GAIN | Generating Antibiotic Incentives Now | June 1, 2031 | 214900 |
Questions
Is there a generic for Brexafemme?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Brexafemme (ibrexafungerp). The Orange Book shows its last listed patent expires June 10, 2039 and its last listed exclusivity ends June 1, 2031.
What is the generic name for Brexafemme?
The active ingredient in Brexafemme is ibrexafungerp, per the FDA Orange Book.
When does the Brexafemme patent expire?
The last patent listed for Brexafemme in the Orange Book expires June 10, 2039. 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.