Last Updated: May 6, 2026

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. There are nine patents protecting this drug. Additional details are available on the BYSANTI profile page.

The generic ingredient in BYSANTI is milsaperidone. Additional details are available on the milsaperidone profile page.
Summary for 220358
Tradename:BYSANTI
Applicant:Vanda Pharms Inc
Ingredient:milsaperidone
Patents:9
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 220358
Generic Entry Date for 220358*:
⤷  Start Trial
Constraining patent/regulatory exclusivity:
10,570,453
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.

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Feb 20, 2026TE:RLD:Yes
Patent:10,563,259Patent Expiration:Jul 24, 2030Product 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:10,563,259Patent Expiration:Jul 24, 2030Product 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
Patent:10,570,453Patent Expiration:Mar 28, 2028Product 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

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

 
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Preferred Citation:

Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2026, www.DrugPatentWatch.com.
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