FDA Orange Book
Is there a generic for Exxua?
Exxua contains gepirone. 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 Exxua (gepirone). The Orange Book shows its last listed patent expires September 2, 2030 and its last listed exclusivity ends September 22, 2028.
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Exxua products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, extended release, oral | EQ 18.2MG BASE | Marketed (Rx) | None | 0 | None |
| tablet, extended release, oral | EQ 36.3MG BASE | Marketed (Rx) | None | 0 | None |
| tablet, extended release, oral | EQ 54.5MG BASE | Marketed (Rx) | None | 0 | None |
| tablet, extended release, oral | EQ 72.6MG BASE | Marketed (Rx) | None | 0 | None |
NDA 021164, held by FABRE KRAMER PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Exxua patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7538116 | September 2, 2030 | Method of use | U-3699 | 021164 |
Exxua exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | September 22, 2028 | 021164 |
Exxua NDC codes
Questions
Is there a generic for Exxua?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Exxua (gepirone). The Orange Book shows its last listed patent expires September 2, 2030 and its last listed exclusivity ends September 22, 2028.
What is the generic name for Exxua?
The active ingredient in Exxua is gepirone, per the FDA Orange Book.
When does the Exxua patent expire?
The last patent listed for Exxua in the Orange Book expires September 2, 2030. 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.