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Last Updated: January 27, 2023

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 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.

Generic filers with tentative approvals for VALBENAZINE TOSYLATE
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing80MGCAPSULE;ORAL
See Plans and PricingSee Plans and Pricing40MGCAPSULE;ORAL
See Plans and PricingSee Plans and Pricing60MGCAPSULE;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 209241-003 Apr 23, 2021 RX Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Neurocrine INGREZZA valbenazine tosylate CAPSULE;ORAL 209241-002 Oct 4, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Neurocrine INGREZZA valbenazine tosylate CAPSULE;ORAL 209241-002 Oct 4, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Neurocrine INGREZZA valbenazine tosylate CAPSULE;ORAL 209241-003 Apr 23, 2021 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Neurocrine INGREZZA valbenazine tosylate CAPSULE;ORAL 209241-002 Oct 4, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Neurocrine INGREZZA valbenazine tosylate CAPSULE;ORAL 209241-001 Apr 11, 2017 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Neurocrine INGREZZA valbenazine tosylate CAPSULE;ORAL 209241-003 Apr 23, 2021 RX Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
>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
China 111655034 施用某些VMAT2抑制剂的方法 (METHODS FOR ADMINISTRATION OF CERTAIN VMAT2 INHIBITORS) See Plans and Pricing
Morocco 43116 DITOSYLATE DE VALBÉNAZINE ET POLYMORPHES ASSOCIÉS See Plans and Pricing
Brazil 112021000019 métodos para administração de certos inibidores de vmat2 See Plans and Pricing
Mexico 2020003421 METODOS PARA LA ADMINISTRACION DE CIERTOS INHIBIDORES DEL TRANSPORTADOR VESICULAR DE MONOAMINA 2 (VMAT2). (METHODS FOR THE ADMINISTRATION OF CERTAIN VMAT2 INHIBITORS.) See Plans and Pricing
Japan 2021502959 特定のVMAT2インヒビターを投与するための方法 See Plans and Pricing
Japan 2021528481 特定のVMAT2阻害剤を投与するための方法 See Plans and Pricing
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 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

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Merck
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McKesson

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