Valbenazine tosylate - Generic Drug Details

What are the generic drug 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-two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

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

Summary for valbenazine tosylate

International Patents:	203
US Patents:	22
Tradenames:	1
Applicants:	1
NDAs:	1
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

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

Dosage:

CAPSULE;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.

Generic filers with tentative approvals for VALBENAZINE TOSYLATE

Applicant	Application No.	Strength	Dosage Form
		80MG	CAPSULE;ORAL
		40MG	CAPSULE;ORAL
		80MG	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

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

International Patents for valbenazine tosylate

Country	Patent Number	Title	Estimated Expiration
Canada	3009169	PROCEDES DE SYNTHESE POUR LA PREPARATION DE DI(4-METHYLBENZENESULFONATE) DE 2-AMINO-3-METHYLBUTANOATE DE (S)-(2R,3R,11BR)-3-ISOBUTYL-9,10-DIMETHOXY-2,3,4,6,7,11B-HEXAHYDRO-1H-PYRI DO[2,1-A]ISOQUINOLEIN-2-YL (SYNTHETIC METHODS FOR PREPARATION OF (S)-(2R,3R,11BR)-3-ISOBUTYL-9,10-DIMETHOXY-2,3,4,6,7,11B-HEXAHYDRO-1H-PYRIDO[2,1-A]ISOQUINOLIN-2-YL 2-AMINO-3-METHYLBUTANOATE DI(4-METHYLBENZENESULFONATE))
Australia	2017395701	Methods for the administration of certain VMAT2 inhibitors
China	115304596	VALBENAZINE盐及其多晶形物 (VALBENAZINE SALTS AND POLYCRYSTALS THEREOF)
Portugal	3368534
Singapore	11202003194Y	METHODS FOR THE ADMINISTRATION OF CERTAIN VMAT2 INHIBITORS
Japan	2022137219	特定のＶＭＡＴ２インヒビターを投与するための方法
Japan	2020514317	特定のＶＭＡＴ２インヒビターを投与するための方法