FDA Orange Book
Is there a generic for Fanapt?
Fanapt contains iloperidone. 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 Fanapt (iloperidone). The Orange Book shows its last listed patent expires December 28, 2031 and its last listed exclusivity ends April 2, 2027.
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Fanapt products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 10MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 12MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 1MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 2MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 4MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 6MG | Marketed (Rx) | None | 0 | None |
| tablet, oral | 8MG | Marketed (Rx) | None | 0 | None |
NDA 022192, held by VANDA PHARMACEUTICALS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Fanapt patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8586610 | November 2, 2027 | Method of use | U-1625 | 022192 |
| 10570453 | March 28, 2028 | Method of use | U-4562 | 022192 |
| 10570453 | March 28, 2028 | Method of use | U-4563 | 022192 |
| 9157121 | April 5, 2030 | Method of use | U-1674 | 022192 |
| 10563259 | July 24, 2030 | Method of use | U-4562 | 022192 |
| 10563259 | July 24, 2030 | Method of use | U-4563 | 022192 |
| 8652776 | August 31, 2030 | Method of use | U-1685 | 022192 |
| 12606869 | September 22, 2030 | Method of use | U-4504 | 022192 |
| 12606869 | September 22, 2030 | Method of use | U-4505 | 022192 |
| 8999638 | October 28, 2030 | Method of use | U-1674 | 022192 |
| 9074255 | December 17, 2030 | Method of use | U-1674 | 022192 |
| 9072742 | January 16, 2031 | Method of use | U-1674 | 022192 |
| 9074256 | February 10, 2031 | Method of use | U-1674 | 022192 |
| 9074254 | December 28, 2031 | Method of use | U-1674 | 022192 |
Fanapt exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| I-939 | New indication | April 2, 2027 | 022192 |
Fanapt NDC codes
Questions
Is there a generic for Fanapt?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Fanapt (iloperidone). The Orange Book shows its last listed patent expires December 28, 2031 and its last listed exclusivity ends April 2, 2027.
What is the generic name for Fanapt?
The active ingredient in Fanapt is iloperidone, per the FDA Orange Book.
When does the Fanapt patent expire?
The last patent listed for Fanapt in the Orange Book expires December 28, 2031. 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.