# BYSANTI — FDA application NDA220358 Informational only - not investment advice. Application NDA220358 · type NDA · FDA status: approved · original approval 2026-02-20 Listed sponsor: VANDA PHARMS INC · [VNDA company profile](/company/VNDA/) · 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 | ## Orange Book patent and exclusivity listings - Patent 10570453, product 001; listed patent expiry date: 2028-03-28. - Patent 10570453, product 001; listed patent expiry date: 2028-03-28. - Patent 10570453, product 002; listed patent expiry date: 2028-03-28. - Patent 10570453, product 002; listed patent expiry date: 2028-03-28. - Patent 10570453, product 003; listed patent expiry date: 2028-03-28. - Patent 10570453, product 003; listed patent expiry date: 2028-03-28. - Patent 10570453, product 004; listed patent expiry date: 2028-03-28. - Patent 10570453, product 004; listed patent expiry date: 2028-03-28. - Patent 10570453, product 005; listed patent expiry date: 2028-03-28. - Patent 10570453, product 005; listed patent expiry date: 2028-03-28. - Patent 10570453, product 006; listed patent expiry date: 2028-03-28. - Patent 10570453, product 006; listed patent expiry date: 2028-03-28. - Patent 10570453, product 007; listed patent expiry date: 2028-03-28. - Patent 10570453, product 007; listed patent expiry date: 2028-03-28. - Patent 9157121, product 001; listed patent expiry date: 2030-04-05. - Patent 9157121, product 001; listed patent expiry date: 2030-04-05. - Patent 9157121, product 002; listed patent expiry date: 2030-04-05. - Patent 9157121, product 002; listed patent expiry date: 2030-04-05. - Patent 9157121, product 003; listed patent expiry date: 2030-04-05. - Patent 9157121, product 003; listed patent expiry date: 2030-04-05. - Patent 9157121, product 004; listed patent expiry date: 2030-04-05. - Patent 9157121, product 004; listed patent expiry date: 2030-04-05. - Patent 9157121, product 005; listed patent expiry date: 2030-04-05. - Patent 9157121, product 005; listed patent expiry date: 2030-04-05. - Patent 9157121, product 006; listed patent expiry date: 2030-04-05. - Patent 9157121, product 006; listed patent expiry date: 2030-04-05. - Patent 9157121, product 007; listed patent expiry date: 2030-04-05. - Patent 9157121, product 007; listed patent expiry date: 2030-04-05. - Patent 10563259, product 001; listed patent expiry date: 2030-07-24. - Patent 10563259, product 001; listed patent expiry date: 2030-07-24. - Patent 10563259, product 002; listed patent expiry date: 2030-07-24. - Patent 10563259, product 002; listed patent expiry date: 2030-07-24. - Patent 10563259, product 003; listed patent expiry date: 2030-07-24. - Patent 10563259, product 003; listed patent expiry date: 2030-07-24. - Patent 10563259, product 004; listed patent expiry date: 2030-07-24. - Patent 10563259, product 004; listed patent expiry date: 2030-07-24. - Patent 10563259, product 005; listed patent expiry date: 2030-07-24. - Patent 10563259, product 005; listed patent expiry date: 2030-07-24. - Patent 10563259, product 006; listed patent expiry date: 2030-07-24. - Patent 10563259, product 006; listed patent expiry date: 2030-07-24. - Patent 10563259, product 007; listed patent expiry date: 2030-07-24. - Patent 10563259, product 007; listed patent expiry date: 2030-07-24. - Patent 12606869, product 001; listed patent expiry date: 2030-09-22. - Patent 12606869, product 001; listed patent expiry date: 2030-09-22. - Patent 12606869, product 002; listed patent expiry date: 2030-09-22. - Patent 12606869, product 002; listed patent expiry date: 2030-09-22. - Patent 12606869, product 003; listed patent expiry date: 2030-09-22. - Patent 12606869, product 003; listed patent expiry date: 2030-09-22. - Patent 12606869, product 004; listed patent expiry date: 2030-09-22. - Patent 12606869, product 004; listed patent expiry date: 2030-09-22. - Patent 12606869, product 005; listed patent expiry date: 2030-09-22. - Patent 12606869, product 005; listed patent expiry date: 2030-09-22. - Patent 12606869, product 006; listed patent expiry date: 2030-09-22. - Patent 12606869, product 006; listed patent expiry date: 2030-09-22. - Patent 12606869, product 007; listed patent expiry date: 2030-09-22. - Patent 12606869, product 007; listed patent expiry date: 2030-09-22. - Patent 8999638, product 001; listed patent expiry date: 2030-10-28. - Patent 8999638, product 001; listed patent expiry date: 2030-10-28. - Patent 8999638, product 002; listed patent expiry date: 2030-10-28. - Patent 8999638, product 002; listed patent expiry date: 2030-10-28. - Patent 8999638, product 003; listed patent expiry date: 2030-10-28. - Patent 8999638, product 003; listed patent expiry date: 2030-10-28. - Patent 8999638, product 004; listed patent expiry date: 2030-10-28. - Patent 8999638, product 004; listed patent expiry date: 2030-10-28. - Patent 8999638, product 005; listed patent expiry date: 2030-10-28. - Patent 8999638, product 005; listed patent expiry date: 2030-10-28. - Patent 8999638, product 006; listed patent expiry date: 2030-10-28. - Patent 8999638, product 006; listed patent expiry date: 2030-10-28. - Patent 8999638, product 007; listed patent expiry date: 2030-10-28. - Patent 8999638, product 007; listed patent expiry date: 2030-10-28. - Patent 9074255, product 001; listed patent expiry date: 2030-12-17. - Patent 9074255, product 001; listed patent expiry date: 2030-12-17. - Patent 9074255, product 002; listed patent expiry date: 2030-12-17. - Patent 9074255, product 002; listed patent expiry date: 2030-12-17. - Patent 9074255, product 003; listed patent expiry date: 2030-12-17. - Patent 9074255, product 003; listed patent expiry date: 2030-12-17. - Patent 9074255, product 004; listed patent expiry date: 2030-12-17. - Patent 9074255, product 004; listed patent expiry date: 2030-12-17. - Patent 9074255, product 005; listed patent expiry date: 2030-12-17. - Patent 9074255, product 005; listed patent expiry date: 2030-12-17. - Patent 9074255, product 006; listed patent expiry date: 2030-12-17. - Patent 9074255, product 006; listed patent expiry date: 2030-12-17. - Patent 9074255, product 007; listed patent expiry date: 2030-12-17. - Patent 9074255, product 007; listed patent expiry date: 2030-12-17. - Patent 9072742, product 001; listed patent expiry date: 2031-01-16. - Patent 9072742, product 001; listed patent expiry date: 2031-01-16. - Patent 9072742, product 002; listed patent expiry date: 2031-01-16. - Patent 9072742, product 002; listed patent expiry date: 2031-01-16. - Patent 9072742, product 003; listed patent expiry date: 2031-01-16. - Patent 9072742, product 003; listed patent expiry date: 2031-01-16. - Patent 9072742, product 004; listed patent expiry date: 2031-01-16. - Patent 9072742, product 004; listed patent expiry date: 2031-01-16. - Patent 9072742, product 005; listed patent expiry date: 2031-01-16. - Patent 9072742, product 005; listed patent expiry date: 2031-01-16. - Patent 9072742, product 006; listed patent expiry date: 2031-01-16. - Patent 9072742, product 006; listed patent expiry date: 2031-01-16. - Patent 9072742, product 007; listed patent expiry date: 2031-01-16. - Patent 9072742, product 007; listed patent expiry date: 2031-01-16. - Patent 9074256, product 001; listed patent expiry date: 2031-02-10. - Patent 9074256, product 001; listed patent expiry date: 2031-02-10. - Patent 9074256, product 002; listed patent expiry date: 2031-02-10. - Patent 9074256, product 002; listed patent expiry date: 2031-02-10. - Patent 9074256, product 003; listed patent expiry date: 2031-02-10. - Patent 9074256, product 003; listed patent expiry date: 2031-02-10. - Patent 9074256, product 004; listed patent expiry date: 2031-02-10. - Patent 9074256, product 004; listed patent expiry date: 2031-02-10. - Patent 9074256, product 005; listed patent expiry date: 2031-02-10. - Patent 9074256, product 005; listed patent expiry date: 2031-02-10. - Patent 9074256, product 006; listed patent expiry date: 2031-02-10. - Patent 9074256, product 006; listed patent expiry date: 2031-02-10. - Patent 9074256, product 007; listed patent expiry date: 2031-02-10. - Patent 9074256, product 007; listed patent expiry date: 2031-02-10. - Patent 9074254, product 001; listed patent expiry date: 2031-12-28. - Patent 9074254, product 001; listed patent expiry date: 2031-12-28. - Patent 9074254, product 002; listed patent expiry date: 2031-12-28. - Patent 9074254, product 002; listed patent expiry date: 2031-12-28. - Patent 9074254, product 003; listed patent expiry date: 2031-12-28. - Patent 9074254, product 003; listed patent expiry date: 2031-12-28. - Patent 9074254, product 004; listed patent expiry date: 2031-12-28. - Patent 9074254, product 004; listed patent expiry date: 2031-12-28. - Patent 9074254, product 005; listed patent expiry date: 2031-12-28. - Patent 9074254, product 005; listed patent expiry date: 2031-12-28. - Patent 9074254, product 006; listed patent expiry date: 2031-12-28. - Patent 9074254, product 006; listed patent expiry date: 2031-12-28. - Patent 9074254, product 007; listed patent expiry date: 2031-12-28. - Patent 9074254, product 007; listed patent expiry date: 2031-12-28. - Patent 12478619, product 001; listed patent expiry date: 2044-05-31. - Patent 12478619, product 001; listed patent expiry date: 2044-05-31. - Patent 12478619, product 002; listed patent expiry date: 2044-05-31. - Patent 12478619, product 002; listed patent expiry date: 2044-05-31. - Patent 12478619, product 003; listed patent expiry date: 2044-05-31. - Patent 12478619, product 003; listed patent expiry date: 2044-05-31. - Patent 12478619, product 004; listed patent expiry date: 2044-05-31. - Patent 12478619, product 004; listed patent expiry date: 2044-05-31. - Patent 12478619, product 005; listed patent expiry date: 2044-05-31. - Patent 12478619, product 005; listed patent expiry date: 2044-05-31. - Patent 12478619, product 006; listed patent expiry date: 2044-05-31. - Patent 12478619, product 006; listed patent expiry date: 2044-05-31. - Patent 12478619, product 007; listed patent expiry date: 2044-05-31. - Patent 12478619, product 007; listed patent expiry date: 2044-05-31. - Exclusivity NCE, product 001; listed exclusivity date: 2031-02-20. - Exclusivity NCE, product 002; listed exclusivity date: 2031-02-20. - Exclusivity NCE, product 003; listed exclusivity date: 2031-02-20. - Exclusivity NCE, product 004; listed exclusivity date: 2031-02-20. - Exclusivity NCE, product 005; listed exclusivity date: 2031-02-20. - Exclusivity NCE, product 006; listed exclusivity date: 2031-02-20. - Exclusivity NCE, product 007; listed exclusivity date: 2031-02-20. 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](/company/VNDA/) - [FDA-approved application index](/drug/) Sources: https://www.fda.gov/drugs/drug-approvals-and-databases/drugsfda-data-files · https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files · https://api.fda.gov/drug/drugsfda.json?search=application_number:NDA220358. FDA data retrieved 2026-08-07. Regulatory listing data as published by FDA; not medical or investment advice.