Valbenazine tosylate - Generic Drug Details

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

Valbenazine tosylate is the generic ingredient in one branded drug marketed by Neurocrine and is included in one NDA. There are twenty patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Valbenazine tosylate has one hundred and seventy-nine patent family members in thirty-two countries.

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

Summary for valbenazine tosylate

International Patents:	179
US Patents:	20
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	11
Patent Applications:	41
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
		80MG	CAPSULE;ORAL
		40MG	CAPSULE;ORAL
		60MG	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

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

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

International Patents for valbenazine tosylate

Country	Patent Number	Title	Estimated Expiration
China	111655034	施用某些VMAT2抑制剂的方法 (METHODS FOR ADMINISTRATION OF CERTAIN VMAT2 INHIBITORS)
Morocco	43116	DITOSYLATE DE VALBÉNAZINE ET POLYMORPHES ASSOCIÉS
Brazil	112021000019	métodos para administração de certos inibidores de vmat2
Mexico	2020003421	METODOS PARA LA ADMINISTRACION DE CIERTOS INHIBIDORES DEL TRANSPORTADOR VESICULAR DE MONOAMINA 2 (VMAT2). (METHODS FOR THE ADMINISTRATION OF CERTAIN VMAT2 INHIBITORS.)
Japan	2021502959	特定のＶＭＡＴ２インヒビターを投与するための方法
Japan	2021528481	特定のＶＭＡＴ２阻害剤を投与するための方法
Morocco	44127	PROCÉDÉS DE SYNTHÈSE POUR LA PRÉPARATION DE DI(4-MÉTHYLBENZÈNESULFONATE) DE 2-AMINO-3-MÉTHYLBUTANOATE DE (S)-(2R,3R,11BR)-3-ISOBUTYL-9,10-DIMÉTHOXY-2,3,4,6,7,11B-HEXAHYDRO-1H-PYRIDO[2,1,-A]ISOQUINOLÉIN-2-YL