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Last Updated: May 18, 2024

Valbenazine tosylate - Generic Drug Details

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What are the generic drug sources for valbenazine tosylate and what is the scope of patent protection?

Valbenazine tosylate is the generic ingredient in two branded drugs marketed by Neurocrine and Lupin Ltd, and is included in two NDAs. There are twenty-two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Valbenazine tosylate has two hundred and seven patent family members in thirty-three countries.

One supplier is listed for this compound. There are three tentative approvals for this compound.

Summary for valbenazine tosylate

International Patents:	207
US Patents:	22
Tradenames:	2
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	13
Patent Applications:	40
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for valbenazine tosylate
DailyMed Link:	valbenazine tosylate at DailyMed

Generic filers with tentative approvals for VALBENAZINE TOSYLATE

Applicant	Application No.	Strength	Dosage Form
⤷ Try a Trial	⤷ Try a Trial	80MG	CAPSULE;ORAL
⤷ Try a Trial	⤷ Try a Trial	40MG	CAPSULE;ORAL
⤷ Try a Trial	⤷ Try a Trial	EQ 60MG BASE	CAPSULE;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for valbenazine tosylate

Drug Class	Vesicular Monoamine Transporter 2 Inhibitor
Mechanism of Action	Vesicular Monoamine Transporter 2 Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for valbenazine tosylate

N07XX	Other nervous system drugs
N07X	OTHER NERVOUS SYSTEM DRUGS
N07	OTHER NERVOUS SYSTEM DRUGS
N	Nervous system

Paragraph IV (Patent) Challenges for VALBENAZINE TOSYLATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
INGREZZA	Capsules	valbenazine tosylate	60 mg	209241	1	2022-02-14
INGREZZA	Capsules	valbenazine tosylate	40 mg and 80 mg	209241	4	2021-04-12

US Patents and Regulatory Information for valbenazine tosylate

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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
Neurocrine	INGREZZA	valbenazine tosylate	CAPSULE;ORAL	209241-002	Oct 4, 2017	AB	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Neurocrine	INGREZZA	valbenazine tosylate	CAPSULE;ORAL	209241-002	Oct 4, 2017	AB	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Neurocrine	INGREZZA	valbenazine tosylate	CAPSULE;ORAL	209241-001	Apr 11, 2017	AB	RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y	Y		⤷ Try a Trial
Neurocrine	INGREZZA	valbenazine tosylate	CAPSULE;ORAL	209241-003	Apr 23, 2021		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Neurocrine	INGREZZA	valbenazine tosylate	CAPSULE;ORAL	209241-001	Apr 11, 2017	AB	RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Neurocrine	INGREZZA	valbenazine tosylate	CAPSULE;ORAL	209241-001	Apr 11, 2017	AB	RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a 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 valbenazine tosylate

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Country	Patent Number	Title	Estimated Expiration
Morocco	53239	PROCÉDÉS D'ADMINISTRATION DE CERTAINS INHIBITEURS DE VMAT2	⤷ Try a Trial
Japan	2022040408	特定のＶＭＡＴ２インヒビターを投与するための方法	⤷ Try a Trial
Jordan	P20200336	طرق إعطاء مثبطات VMAT2 معينة (METHODS FOR THE ADMINISTRATION OF CERTAIN VMAT2 INHIBITORS)	⤷ Try a Trial
Japan	2022174343	特定のＶＭＡＴ２インヒビターを投与するための方法	⤷ Try a Trial
European Patent Office	3875459	SELS DE VALBÉNAZINE ET LEURS POLYMORPHES (VALBENAZINE SALTS AND POLYMORPHS THEREOF)	⤷ Try a Trial
Mexico	2019008853	METODOS PARA LA ADMINISTRACION DE CIERTOS INHIBIDORES DE PROTEINA TRANSPORTADORA TRANSPORTADOR DE MONOAMINA VESICULAR-2 (VMAT2). (METHODS FOR THE ADMINISTRATION OF CERTAIN VMAT2 INHIBITORS.)	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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