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Last Updated: March 28, 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 freedom to operate?

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 two patent family members in thirty-three countries.

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

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for VALBENAZINE TOSYLATE
Generic Entry Date for VALBENAZINE TOSYLATE*:
Constraining patent/regulatory exclusivity:
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
⤷  Try a Trial⤷  Try a Trial80MGCAPSULE;ORAL
⤷  Try a Trial⤷  Try a Trial40MGCAPSULE;ORAL
⤷  Try a Trial⤷  Try a Trial80MGCAPSULE;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
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 209241-002 Oct 4, 2017 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Neurocrine INGREZZA valbenazine tosylate CAPSULE;ORAL 209241-001 Apr 11, 2017 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Neurocrine INGREZZA valbenazine tosylate CAPSULE;ORAL 209241-002 Oct 4, 2017 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Neurocrine INGREZZA valbenazine tosylate CAPSULE;ORAL 209241-002 Oct 4, 2017 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  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

Country Patent Number Title Estimated Expiration
European Patent Office 3394057 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 (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]lSOQUINOLIN-2-YL 2-AMINO-3-METHYLBUTANOATE DI(4-METHYLBENZENESULFONATE)) ⤷  Try a Trial
Japan 7090151 ⤷  Try a Trial
South Korea 20180075591 발베나진 염 및 그의 다형체 ⤷  Try a Trial
Canada 3051830 METHODES D'ADMINISTRATION DE CERTAINS INHIBITEURS DE VMAT2 (METHODS FOR THE ADMINISTRATION OF CERTAIN VMAT2 INHIBITORS) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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