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.
Summary for valbenazine tosylate
International Patents: | 179 |
US Patents: | 20 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 11 |
Patent Applications: | 41 |
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 |
See Plans and Pricing | See Plans and Pricing | 80MG | CAPSULE;ORAL |
See Plans and Pricing | See Plans and Pricing | 40MG | CAPSULE;ORAL |
See Plans and Pricing | See Plans and Pricing | 60MG | 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 |
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
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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