FDA Orange Book
Is there a generic for Bysanti?
Bysanti contains milsaperidone. 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 Bysanti (milsaperidone). The Orange Book shows its last listed patent expires May 31, 2044 and its last listed exclusivity ends February 20, 2031.
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Bysanti 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 220358, 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.
Bysanti patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 10570453 | March 28, 2028 | Method of use | U-4436 | 220358 |
| 10570453 | March 28, 2028 | Method of use | U-4437 | 220358 |
| 9157121 | April 5, 2030 | Method of use | U-4436 | 220358 |
| 9157121 | April 5, 2030 | Method of use | U-4437 | 220358 |
| 10563259 | July 24, 2030 | Method of use | U-4436 | 220358 |
| 10563259 | July 24, 2030 | Method of use | U-4437 | 220358 |
| 12606869 | September 22, 2030 | Method of use | U-4506 | 220358 |
| 12606869 | September 22, 2030 | Method of use | U-4507 | 220358 |
| 8999638 | October 28, 2030 | Method of use | U-4436 | 220358 |
| 8999638 | October 28, 2030 | Method of use | U-4437 | 220358 |
| 9074255 | December 17, 2030 | Method of use | U-4436 | 220358 |
| 9074255 | December 17, 2030 | Method of use | U-4437 | 220358 |
| 9072742 | January 16, 2031 | Method of use | U-4436 | 220358 |
| 9072742 | January 16, 2031 | Method of use | U-4437 | 220358 |
| 9074256 | February 10, 2031 | Method of use | U-4436 | 220358 |
| 9074256 | February 10, 2031 | Method of use | U-4437 | 220358 |
| 9074254 | December 28, 2031 | Method of use | U-4436 | 220358 |
| 9074254 | December 28, 2031 | Method of use | U-4437 | 220358 |
| 12478619 | May 31, 2044 | Method of use | U-4434 | 220358 |
| 12478619 | May 31, 2044 | Method of use | U-4435 | 220358 |
Bysanti exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NCE | New chemical entity | February 20, 2031 | 220358 |
Bysanti NDC codes
Questions
Is there a generic for Bysanti?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Bysanti (milsaperidone). The Orange Book shows its last listed patent expires May 31, 2044 and its last listed exclusivity ends February 20, 2031.
What is the generic name for Bysanti?
The active ingredient in Bysanti is milsaperidone, per the FDA Orange Book.
When does the Bysanti patent expire?
The last patent listed for Bysanti in the Orange Book expires May 31, 2044. 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.