You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: June 12, 2024

Valbenazine tosylate - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


What are the generic drug 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 and Lupin Ltd, and is included in three 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 eight patent family members in thirty-three countries.

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

Generic filers with tentative approvals for VALBENAZINE TOSYLATE
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign Up80MGCAPSULE;ORAL
⤷  Sign Up⤷  Sign Up40MGCAPSULE;ORAL
⤷  Sign Up⤷  Sign UpEQ 60MG BASECAPSULE;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
Anatomical Therapeutic Chemical (ATC) Classes for valbenazine tosylate
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 ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Neurocrine INGREZZA valbenazine tosylate CAPSULE;ORAL 209241-001 Apr 11, 2017 AB RX Yes No ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Neurocrine INGREZZA valbenazine tosylate CAPSULE;ORAL 209241-002 Oct 4, 2017 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Neurocrine INGREZZA valbenazine tosylate CAPSULE;ORAL 209241-002 Oct 4, 2017 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Neurocrine INGREZZA valbenazine tosylate CAPSULE;ORAL 209241-003 Apr 23, 2021 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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

Country Patent Number Title Estimated Expiration
Cyprus 1113838 ⤷  Sign Up
Philippines 12018500900 VALBENAZINE SALTS AND POLYMORPHS THEREOF ⤷  Sign Up
World Intellectual Property Organization (WIPO) 2017112857 ⤷  Sign Up
Australia 2007317242 Substituted 3-isobutyl-9, 10-dimethoxy-1,3,4,6,7,11B-hexahydro-2H-pyrido[2,1-a] isoquinolin-2-ol compounds and methods relating thereto ⤷  Sign Up
Australia 2022203201 Methods for the administration of certain VMAT2 inhibitors ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Make Better Decisions: Try a trial or see plans & pricing

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.