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Tentative Approval — This application has been tentatively approved by the FDA but is not yet listed in the Orange Book. It is blocked from final approval by unexpired patents or exclusivities on the reference listed drug.

VALBENAZINE TOSYLATE

ANDA

Tentative Approval

VALBENAZINE TOSYLATE | A215984 | TEVA PHARMS INC

Hatch-Waxman Litigation

2 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
Neurocrine Biosciences, Inc. v. Teva Pharmaceuticals, Inc. et al 1:2021cv01148 1 patentANDA 215984Valbenazine	D. Del.	2021-08-06	Terminated 2023-03-29	—
Neurocrine Biosciences, Inc. v. Teva Pharmaceuticals, Inc. et al 1:2021cv01043 13 patentsANDA 215984Valbenazine	D. Del.	2021-07-16	Terminated 2023-03-29	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

API Supply Chain4 active DMFs

4 active API suppliers hold Drug Master Files for this ingredient.

MSN LIFE SCIENCES PRIVATE LTDVALBENAZINE TOSYLATE

DMF 347202020

CRYSTAL PHARMACEUTICAL SUZHOU CO LTDVALBENAZINE TOSYLATE

DMF 351952020

LUPIN MANUFACTURING SOLUTIONS LTDVALBENAZINE TOSYLATE

DMF 352462020

TAPI NL BVVALBENAZINE TOSYLATE

DMF 352902020

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Dec 20, 2022	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 40MG

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CAPSULE;ORAL | TA Date: 2026-01-21 00:00:00

No patent or exclusivity listings for this strength.

#002 — 80MG

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CAPSULE;ORAL | TA Date: 2026-01-21 00:00:00