Valbenazine tosylate - Generic Drug Details

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

Valbenazine tosylate is the generic ingredient in three branded drugs marketed by Neurocrine, Lupin Ltd, and Zydus, and is included in four 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 fourteen patent family members in thirty-four countries.

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

Summary for valbenazine tosylate

International Patents:	214
US Patents:	22
Tradenames:	3
Applicants:	3
NDAs:	4
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	13
Patent Applications:	38
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
⤷ Subscribe	⤷ Subscribe	80MG	CAPSULE;ORAL
⤷ Subscribe	⤷ Subscribe	40MG	CAPSULE;ORAL
⤷ Subscribe	⤷ Subscribe	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	209241-003	Apr 23, 2021	AB	RX	Yes	No	11,026,931	⤷ Subscribe				⤷ Subscribe
Neurocrine	INGREZZA	valbenazine tosylate	CAPSULE;ORAL	209241-003	Apr 23, 2021	AB	RX	Yes	No	10,940,141	⤷ Subscribe				⤷ Subscribe
Neurocrine	INGREZZA SPRINKLE	valbenazine tosylate	CAPSULE;ORAL	218390-001	Apr 30, 2024		RX	Yes	No	10,952,997	⤷ Subscribe				⤷ Subscribe
Neurocrine	INGREZZA SPRINKLE	valbenazine tosylate	CAPSULE;ORAL	218390-001	Apr 30, 2024		RX	Yes	No	11,026,931	⤷ Subscribe				⤷ Subscribe
>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
Philippines	12019501732	METHODS FOR THE ADMINISTRATION OF CERTAIN VMAT2 INHIBITORS	⤷ Subscribe
Brazil	112018008460	sais de valbenazina e seus polimorfos	⤷ Subscribe
World Intellectual Property Organization (WIPO)	2017075340		⤷ Subscribe
Hungary	E059065		⤷ Subscribe
>Country	>Patent Number	>Title	>Estimated Expiration

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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. 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.