Details for New Drug Application (NDA): 220358
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NDA 220358 describes BYSANTI, which is a drug marketed by Vanda Pharms Inc and is included in one NDA. It is available from one supplier. There are ten patents protecting this drug. Additional details are available on the BYSANTI profile page.
The generic ingredient in BYSANTI is milsaperidone. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the milsaperidone profile page.
The generic ingredient in BYSANTI is milsaperidone. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the milsaperidone profile page.
Summary for 220358
| Tradename: | BYSANTI |
| Applicant: | Vanda Pharms Inc |
| Ingredient: | milsaperidone |
| Patents: | 10 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 220358
Generic Entry Date for 220358*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY Dosage:
TABLET;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Suppliers and Packaging for NDA: 220358
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| BYSANTI | milsaperidone | TABLET;ORAL | 220358 | NDA | Vanda Pharmaceuticals Inc. | 43068-701 | 43068-701-02 | 60 TABLET in 1 BOTTLE (43068-701-02) |
| BYSANTI | milsaperidone | TABLET;ORAL | 220358 | NDA | Vanda Pharmaceuticals Inc. | 43068-702 | 43068-702-02 | 60 TABLET in 1 BOTTLE (43068-702-02) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | 1MG | ||||
| Approval Date: | Feb 20, 2026 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Feb 20, 2031 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | 10,563,259 | Patent Expiration: | Jul 24, 2030 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | METHOD FOR ACUTE TREATMENT OF MANIC OR MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER IN ADULTS BY ADMINISTERING MILSAPERIDONE TO A PATIENT BY LOWERING THE DOSE AFTER DETERMINING THAT THE PATIENT HAS A GENETIC PREDISPOSITION FOR QT PROLONGATION | ||||||||
| Patent: | 10,563,259 | Patent Expiration: | Jul 24, 2030 | Product Flag? | Substance Flag? | Delist Request? | |||
| Patented Use: | METHOD FOR TREATMENT OF SCHIZOPHRENIA IN ADULTS BY ADMINISTERING MILSAPERIDONE TO A PATIENT BY LOWERING THE DOSE AFTER DETERMINING THAT THE PATIENT HAS A GENETIC PREDISPOSITION FOR QT PROLONGATION | ||||||||
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