BYSANTI Drug Patent Profile

Name: BYSANTI Drug Patent, Exclusivity, and Generic Launch Dataset
Creator: DrugPatentWatch
License: https://www.drugpatentwatch.com/terms.php

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Which patents cover Bysanti, and what generic alternatives are available?

Bysanti is a drug marketed by Vanda Pharms Inc and is included in one NDA. There are ten patents protecting this drug.

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.

DrugPatentWatch^® Generic Entry Outlook for Bysanti

Bysanti will be eligible for patent challenges on February 20, 2030. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 20, 2031. This may change due to patent challenges or generic licensing.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Summary for BYSANTI

US Patents:	10
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Patent Applications:	34
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for BYSANTI
What excipients (inactive ingredients) are in BYSANTI?	BYSANTI excipients list
DailyMed Link:	BYSANTI at DailyMed

Drug patent expirations by year for BYSANTI

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for BYSANTI

Generic Entry Date for BYSANTI^: ⤷ Start Trial* Constraining patent/regulatory exclusivity: NEW CHEMICAL ENTITY NDA: 220358 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.

US Patents and Regulatory Information for BYSANTI

BYSANTI is protected by twenty US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of BYSANTI is ⤷ Start Trial.

This potential generic entry date is based on NEW CHEMICAL ENTITY.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Vanda Pharms Inc	BYSANTI	milsaperidone	TABLET;ORAL	220358-005	Feb 20, 2026		RX	Yes	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Vanda Pharms Inc	BYSANTI	milsaperidone	TABLET;ORAL	220358-006	Feb 20, 2026		RX	Yes	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Vanda Pharms Inc	BYSANTI	milsaperidone	TABLET;ORAL	220358-007	Feb 20, 2026		RX	Yes	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Vanda Pharms Inc	BYSANTI	milsaperidone	TABLET;ORAL	220358-003	Feb 20, 2026		RX	Yes	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Vanda Pharms Inc	BYSANTI	milsaperidone	TABLET;ORAL	220358-007	Feb 20, 2026		RX	Yes	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Vanda Pharms Inc	BYSANTI	milsaperidone	TABLET;ORAL	220358-005	Feb 20, 2026		RX	Yes	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Vanda Pharms Inc	BYSANTI	milsaperidone	TABLET;ORAL	220358-003	Feb 20, 2026		RX	Yes	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

International Patents for BYSANTI

When does loss-of-exclusivity occur for BYSANTI?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

European Patent Office

Patent: 34873
Patent: PROCÉDÉ PERMETTANT DE PRÉDIRE UNE PRÉDISPOSITION À LA PROLONGATION DU QT (METHOD OF PREDICTING A PREDISPOSITION TO QT PROLONGATION)
Estimated Expiration: ⤷ Start Trial

Japan

Patent: 86094
Estimated Expiration: ⤷ Start Trial

Patent: 10522773
Estimated Expiration: ⤷ Start Trial

Spain

Patent: 42967
Estimated Expiration: ⤷ Start Trial

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering BYSANTI around the world.

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Country	Patent Number	Title	Estimated Expiration
Canada	2757713	METHODE DE TRAITEMENT BASEE SUR LES POLYMORPHISMES DU GENE KCNQ1 (METHOD OF TREATMENT BASED ON POLYMORPHISMS OF THE KCNQ1 GENE)	⤷ Start Trial
European Patent Office	2417267	MÉTHODE DE TRAITEMENT BASÉE SUR LES POLYMORPHISMES DU GÈNE KCNQ1 (METHOD OF TREATMENT BASED ON POLYMORPHISMS OF THE KCNQ1 GENE)	⤷ Start Trial
European Patent Office	3023506	PROCÉDÉ DE TRAITEMENT BASÉS SUR DES POLYMORPHISMES DU GÈNE KCNQ1 (METHOD OF TREATMENT BASED ON POLYMORPHISMS OF THE KCNQ1 GENE)	⤷ Start Trial
European Patent Office	3354753	PROCÉDÉ DE TRAITEMENT À BASESDE POLYMORPHISMES DU GÈNE KCNQ1 (METHOD OF TREATMENT BASED ON POLYMORPHISMS OF THE KCNQ1 GENE)	⤷ Start Trial
Spain	2604102		⤷ Start Trial
Spain	2673603		⤷ Start Trial
Spain	2792126		⤷ Start Trial
>Country	>Patent Number	>Title	>Estimated Expiration