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VALBENAZINE TOSYLATE

ANDA

VALBENAZINE TOSYLATE | A216064 | LUPIN LTD

2 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: INGREZZA(TE code: AB)

Hatch-Waxman Litigation

2 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
Neurocrine Biosciences, Inc. v. Lupin Limited et al 1:2022cv00639 19 patentsANDA 216064, 209241Valbenazine	D. Del.	2022-05-13	Terminated 2023-11-13	—
Neurocrine Biosciences, Inc. v. Lupin Limited et al 1:2021cv01042 16 patentsANDA 216064Valbenazine (tosylate salt)	D. Del.	2021-07-16	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

2 letters from Drugs@FDA

Date	Submission	Document
May 31, 2024	ORIG -1	View Letter (PDF)
Apr 28, 2023	ORIG -2	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

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#001 — EQ 40MG BASE

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Apr 5, 2024

No patent or exclusivity listings for this strength.

#002 — EQ 80MG BASE

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Apr 5, 2024