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VALBENAZINE TOSYLATE

ANDA

VALBENAZINE TOSYLATE | A216137 | ZYDUS LIFESCIENCES GLOBAL FZE

3 strengths0 unique patents0 unique exclusivities

Hatch-Waxman Litigation

2 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
Neurocrine Biosciences, Inc. v. Zydus Pharmaceuticals (USA) Inc. et al 1:2023cv00266 2 patentsANDA 216137Valbenazine	D. Del.	2023-03-10	Terminated 2023-11-13	—
Neurocrine Biosciences, Inc. v. Zydus Pharmaceuticals (USA) Inc. et al 1:2021cv01118 13 patentsANDA 216137valbenazine	D. Del.	2021-07-30	Terminated 2023-11-13	—

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 (3)

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#001 — EQ 40MG BASE

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Aug 7, 2024

No patent or exclusivity listings for this strength.

#002 — EQ 60MG BASE

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Aug 7, 2024

#003 — EQ 80MG BASE

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Aug 7, 2024