BYSANTI — FDA application NDA220358
Listed sponsor: VANDA PHARMS INC · VNDA company profile · exact_unique
Sponsor as listed in Drugs@FDA at retrieval (2026-08-07); FDA sponsor listings can lag ownership transfers.
FDA application facts
| Product | FDA-listed trade name | Active ingredient | Dosage form | Route | Strength | Marketing status | TE code | RLD |
|---|---|---|---|---|---|---|---|---|
| 001 | BYSANTI | MILSAPERIDONE | TABLET | ORAL | 1MG | Prescription | not listed | Yes |
| 002 | BYSANTI | MILSAPERIDONE | TABLET | ORAL | 2MG | Prescription | not listed | Yes |
| 003 | BYSANTI | MILSAPERIDONE | TABLET | ORAL | 4MG | Prescription | not listed | Yes |
| 004 | BYSANTI | MILSAPERIDONE | TABLET | ORAL | 6MG | Prescription | not listed | Yes |
| 005 | BYSANTI | MILSAPERIDONE | TABLET | ORAL | 8MG | Prescription | not listed | Yes |
| 006 | BYSANTI | MILSAPERIDONE | TABLET | ORAL | 10MG | Prescription | not listed | Yes |
| 007 | BYSANTI | MILSAPERIDONE | TABLET | ORAL | 12MG | Prescription | not listed | Yes |
Product, form, strength, reference-drug and marketing-status fields: Drugs@FDA data files; TE and RLD fields: Orange Book data files. Retrieved 2026-08-07.
Orange Book patent and exclusivity listings
| Listing | Product | Descriptive date | Flags/code |
|---|---|---|---|
| Patent 10570453 | 001 | listed patent expiry date: 2028-03-28 | U-4436 |
| Patent 10570453 | 001 | listed patent expiry date: 2028-03-28 | U-4437 |
| Patent 10570453 | 002 | listed patent expiry date: 2028-03-28 | U-4437 |
| Patent 10570453 | 002 | listed patent expiry date: 2028-03-28 | U-4436 |
| Patent 10570453 | 003 | listed patent expiry date: 2028-03-28 | U-4437 |
| Patent 10570453 | 003 | listed patent expiry date: 2028-03-28 | U-4436 |
| Patent 10570453 | 004 | listed patent expiry date: 2028-03-28 | U-4437 |
| Patent 10570453 | 004 | listed patent expiry date: 2028-03-28 | U-4436 |
| Patent 10570453 | 005 | listed patent expiry date: 2028-03-28 | U-4437 |
| Patent 10570453 | 005 | listed patent expiry date: 2028-03-28 | U-4436 |
| Patent 10570453 | 006 | listed patent expiry date: 2028-03-28 | U-4437 |
| Patent 10570453 | 006 | listed patent expiry date: 2028-03-28 | U-4436 |
| Patent 10570453 | 007 | listed patent expiry date: 2028-03-28 | U-4437 |
| Patent 10570453 | 007 | listed patent expiry date: 2028-03-28 | U-4436 |
| Patent 9157121 | 001 | listed patent expiry date: 2030-04-05 | U-4436 |
| Patent 9157121 | 001 | listed patent expiry date: 2030-04-05 | U-4437 |
| Patent 9157121 | 002 | listed patent expiry date: 2030-04-05 | U-4437 |
| Patent 9157121 | 002 | listed patent expiry date: 2030-04-05 | U-4436 |
| Patent 9157121 | 003 | listed patent expiry date: 2030-04-05 | U-4437 |
| Patent 9157121 | 003 | listed patent expiry date: 2030-04-05 | U-4436 |
| Patent 9157121 | 004 | listed patent expiry date: 2030-04-05 | U-4437 |
| Patent 9157121 | 004 | listed patent expiry date: 2030-04-05 | U-4436 |
| Patent 9157121 | 005 | listed patent expiry date: 2030-04-05 | U-4437 |
| Patent 9157121 | 005 | listed patent expiry date: 2030-04-05 | U-4436 |
| Patent 9157121 | 006 | listed patent expiry date: 2030-04-05 | U-4437 |
| Patent 9157121 | 006 | listed patent expiry date: 2030-04-05 | U-4436 |
| Patent 9157121 | 007 | listed patent expiry date: 2030-04-05 | U-4437 |
| Patent 9157121 | 007 | listed patent expiry date: 2030-04-05 | U-4436 |
| Patent 10563259 | 001 | listed patent expiry date: 2030-07-24 | U-4436 |
| Patent 10563259 | 001 | listed patent expiry date: 2030-07-24 | U-4437 |
| Patent 10563259 | 002 | listed patent expiry date: 2030-07-24 | U-4436 |
| Patent 10563259 | 002 | listed patent expiry date: 2030-07-24 | U-4437 |
| Patent 10563259 | 003 | listed patent expiry date: 2030-07-24 | U-4436 |
| Patent 10563259 | 003 | listed patent expiry date: 2030-07-24 | U-4437 |
| Patent 10563259 | 004 | listed patent expiry date: 2030-07-24 | U-4436 |
| Patent 10563259 | 004 | listed patent expiry date: 2030-07-24 | U-4437 |
| Patent 10563259 | 005 | listed patent expiry date: 2030-07-24 | U-4436 |
| Patent 10563259 | 005 | listed patent expiry date: 2030-07-24 | U-4437 |
| Patent 10563259 | 006 | listed patent expiry date: 2030-07-24 | U-4437 |
| Patent 10563259 | 006 | listed patent expiry date: 2030-07-24 | U-4436 |
| Patent 10563259 | 007 | listed patent expiry date: 2030-07-24 | U-4437 |
| Patent 10563259 | 007 | listed patent expiry date: 2030-07-24 | U-4436 |
| Patent 12606869 | 001 | listed patent expiry date: 2030-09-22 | U-4506 |
| Patent 12606869 | 001 | listed patent expiry date: 2030-09-22 | U-4507 |
| Patent 12606869 | 002 | listed patent expiry date: 2030-09-22 | U-4506 |
| Patent 12606869 | 002 | listed patent expiry date: 2030-09-22 | U-4507 |
| Patent 12606869 | 003 | listed patent expiry date: 2030-09-22 | U-4506 |
| Patent 12606869 | 003 | listed patent expiry date: 2030-09-22 | U-4507 |
| Patent 12606869 | 004 | listed patent expiry date: 2030-09-22 | U-4506 |
| Patent 12606869 | 004 | listed patent expiry date: 2030-09-22 | U-4507 |
| Patent 12606869 | 005 | listed patent expiry date: 2030-09-22 | U-4506 |
| Patent 12606869 | 005 | listed patent expiry date: 2030-09-22 | U-4507 |
| Patent 12606869 | 006 | listed patent expiry date: 2030-09-22 | U-4506 |
| Patent 12606869 | 006 | listed patent expiry date: 2030-09-22 | U-4507 |
| Patent 12606869 | 007 | listed patent expiry date: 2030-09-22 | U-4506 |
| Patent 12606869 | 007 | listed patent expiry date: 2030-09-22 | U-4507 |
| Patent 8999638 | 001 | listed patent expiry date: 2030-10-28 | U-4436 |
| Patent 8999638 | 001 | listed patent expiry date: 2030-10-28 | U-4437 |
| Patent 8999638 | 002 | listed patent expiry date: 2030-10-28 | U-4436 |
| Patent 8999638 | 002 | listed patent expiry date: 2030-10-28 | U-4437 |
| Patent 8999638 | 003 | listed patent expiry date: 2030-10-28 | U-4436 |
| Patent 8999638 | 003 | listed patent expiry date: 2030-10-28 | U-4437 |
| Patent 8999638 | 004 | listed patent expiry date: 2030-10-28 | U-4436 |
| Patent 8999638 | 004 | listed patent expiry date: 2030-10-28 | U-4437 |
| Patent 8999638 | 005 | listed patent expiry date: 2030-10-28 | U-4436 |
| Patent 8999638 | 005 | listed patent expiry date: 2030-10-28 | U-4437 |
| Patent 8999638 | 006 | listed patent expiry date: 2030-10-28 | U-4436 |
| Patent 8999638 | 006 | listed patent expiry date: 2030-10-28 | U-4437 |
| Patent 8999638 | 007 | listed patent expiry date: 2030-10-28 | U-4436 |
| Patent 8999638 | 007 | listed patent expiry date: 2030-10-28 | U-4437 |
| Patent 9074255 | 001 | listed patent expiry date: 2030-12-17 | U-4436 |
| Patent 9074255 | 001 | listed patent expiry date: 2030-12-17 | U-4437 |
| Patent 9074255 | 002 | listed patent expiry date: 2030-12-17 | U-4437 |
| Patent 9074255 | 002 | listed patent expiry date: 2030-12-17 | U-4436 |
| Patent 9074255 | 003 | listed patent expiry date: 2030-12-17 | U-4437 |
| Patent 9074255 | 003 | listed patent expiry date: 2030-12-17 | U-4436 |
| Patent 9074255 | 004 | listed patent expiry date: 2030-12-17 | U-4437 |
| Patent 9074255 | 004 | listed patent expiry date: 2030-12-17 | U-4436 |
| Patent 9074255 | 005 | listed patent expiry date: 2030-12-17 | U-4437 |
| Patent 9074255 | 005 | listed patent expiry date: 2030-12-17 | U-4436 |
| Patent 9074255 | 006 | listed patent expiry date: 2030-12-17 | U-4437 |
| Patent 9074255 | 006 | listed patent expiry date: 2030-12-17 | U-4436 |
| Patent 9074255 | 007 | listed patent expiry date: 2030-12-17 | U-4437 |
| Patent 9074255 | 007 | listed patent expiry date: 2030-12-17 | U-4436 |
| Patent 9072742 | 001 | listed patent expiry date: 2031-01-16 | U-4436 |
| Patent 9072742 | 001 | listed patent expiry date: 2031-01-16 | U-4437 |
| Patent 9072742 | 002 | listed patent expiry date: 2031-01-16 | U-4436 |
| Patent 9072742 | 002 | listed patent expiry date: 2031-01-16 | U-4437 |
| Patent 9072742 | 003 | listed patent expiry date: 2031-01-16 | U-4436 |
| Patent 9072742 | 003 | listed patent expiry date: 2031-01-16 | U-4437 |
| Patent 9072742 | 004 | listed patent expiry date: 2031-01-16 | U-4436 |
| Patent 9072742 | 004 | listed patent expiry date: 2031-01-16 | U-4437 |
| Patent 9072742 | 005 | listed patent expiry date: 2031-01-16 | U-4436 |
| Patent 9072742 | 005 | listed patent expiry date: 2031-01-16 | U-4437 |
| Patent 9072742 | 006 | listed patent expiry date: 2031-01-16 | U-4436 |
| Patent 9072742 | 006 | listed patent expiry date: 2031-01-16 | U-4437 |
| Patent 9072742 | 007 | listed patent expiry date: 2031-01-16 | U-4436 |
| Patent 9072742 | 007 | listed patent expiry date: 2031-01-16 | U-4437 |
| Patent 9074256 | 001 | listed patent expiry date: 2031-02-10 | U-4436 |
| Patent 9074256 | 001 | listed patent expiry date: 2031-02-10 | U-4437 |
| Patent 9074256 | 002 | listed patent expiry date: 2031-02-10 | U-4436 |
| Patent 9074256 | 002 | listed patent expiry date: 2031-02-10 | U-4437 |
| Patent 9074256 | 003 | listed patent expiry date: 2031-02-10 | U-4436 |
| Patent 9074256 | 003 | listed patent expiry date: 2031-02-10 | U-4437 |
| Patent 9074256 | 004 | listed patent expiry date: 2031-02-10 | U-4436 |
| Patent 9074256 | 004 | listed patent expiry date: 2031-02-10 | U-4437 |
| Patent 9074256 | 005 | listed patent expiry date: 2031-02-10 | U-4437 |
| Patent 9074256 | 005 | listed patent expiry date: 2031-02-10 | U-4436 |
| Patent 9074256 | 006 | listed patent expiry date: 2031-02-10 | U-4437 |
| Patent 9074256 | 006 | listed patent expiry date: 2031-02-10 | U-4436 |
| Patent 9074256 | 007 | listed patent expiry date: 2031-02-10 | U-4437 |
| Patent 9074256 | 007 | listed patent expiry date: 2031-02-10 | U-4436 |
| Patent 9074254 | 001 | listed patent expiry date: 2031-12-28 | U-4436 |
| Patent 9074254 | 001 | listed patent expiry date: 2031-12-28 | U-4437 |
| Patent 9074254 | 002 | listed patent expiry date: 2031-12-28 | U-4437 |
| Patent 9074254 | 002 | listed patent expiry date: 2031-12-28 | U-4436 |
| Patent 9074254 | 003 | listed patent expiry date: 2031-12-28 | U-4437 |
| Patent 9074254 | 003 | listed patent expiry date: 2031-12-28 | U-4436 |
| Patent 9074254 | 004 | listed patent expiry date: 2031-12-28 | U-4437 |
| Patent 9074254 | 004 | listed patent expiry date: 2031-12-28 | U-4436 |
| Patent 9074254 | 005 | listed patent expiry date: 2031-12-28 | U-4437 |
| Patent 9074254 | 005 | listed patent expiry date: 2031-12-28 | U-4436 |
| Patent 9074254 | 006 | listed patent expiry date: 2031-12-28 | U-4437 |
| Patent 9074254 | 006 | listed patent expiry date: 2031-12-28 | U-4436 |
| Patent 9074254 | 007 | listed patent expiry date: 2031-12-28 | U-4437 |
| Patent 9074254 | 007 | listed patent expiry date: 2031-12-28 | U-4436 |
| Patent 12478619 | 001 | listed patent expiry date: 2044-05-31 | U-4434 |
| Patent 12478619 | 001 | listed patent expiry date: 2044-05-31 | U-4435 |
| Patent 12478619 | 002 | listed patent expiry date: 2044-05-31 | U-4435 |
| Patent 12478619 | 002 | listed patent expiry date: 2044-05-31 | U-4434 |
| Patent 12478619 | 003 | listed patent expiry date: 2044-05-31 | U-4435 |
| Patent 12478619 | 003 | listed patent expiry date: 2044-05-31 | U-4434 |
| Patent 12478619 | 004 | listed patent expiry date: 2044-05-31 | U-4435 |
| Patent 12478619 | 004 | listed patent expiry date: 2044-05-31 | U-4434 |
| Patent 12478619 | 005 | listed patent expiry date: 2044-05-31 | U-4435 |
| Patent 12478619 | 005 | listed patent expiry date: 2044-05-31 | U-4434 |
| Patent 12478619 | 006 | listed patent expiry date: 2044-05-31 | U-4435 |
| Patent 12478619 | 006 | listed patent expiry date: 2044-05-31 | U-4434 |
| Patent 12478619 | 007 | listed patent expiry date: 2044-05-31 | U-4435 |
| Patent 12478619 | 007 | listed patent expiry date: 2044-05-31 | U-4434 |
| Exclusivity NCE | 001 | listed exclusivity date: 2031-02-20 | FDA code as listed |
| Exclusivity NCE | 002 | listed exclusivity date: 2031-02-20 | FDA code as listed |
| Exclusivity NCE | 003 | listed exclusivity date: 2031-02-20 | FDA code as listed |
| Exclusivity NCE | 004 | listed exclusivity date: 2031-02-20 | FDA code as listed |
| Exclusivity NCE | 005 | listed exclusivity date: 2031-02-20 | FDA code as listed |
| Exclusivity NCE | 006 | listed exclusivity date: 2031-02-20 | FDA code as listed |
| Exclusivity NCE | 007 | listed exclusivity date: 2031-02-20 | FDA code as listed |
Patent and exclusivity dates are regulatory listings from the FDA Orange Book; no relationship to revenue or future sales is stated or implied.
Compound cross-links
- MILSAPERIDONE · UNII 7SV1ZOG031 · no lmmol compound match
Ingredient–compound links use FDA openFDA/GSRS identifiers and an exact lmmol InChIKey join. Ingredient names cannot create a link.
Related pages
Sponsor company · FDA-approved application index
Peer clusters: No published peer-cluster link for this sponsor.
Sources: Drugs@FDA · Orange Book · openFDA application record. FDA data retrieved 2026-08-07.
Regulatory listing data as published by FDA; not medical or investment advice.