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ILOPERIDONE

ANDA

ILOPERIDONE | A207231 | INVENTIA HEALTHCARE LTD

7 strengths0 unique patents0 unique exclusivities

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Vanda Pharmaceuticals Inc. v. Inventia Healthcare Limited 1:2015cv00921 2 patentsANDA 207231iloperidone	D. Del.	2015-10-13	Terminated 2025-09-23	—

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

API Supply Chain6 active DMFs1 inactive

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

FORMOSA LABORATORIES INCILOPERIDONE

DMF 244812010

ALEMBIC PHARMACEUTICALS LTDILOPERIDONE

DMF 248322011

SYMED LABS LTDILOPERIDONE

DMF 249322011

PROCOS SPAILOPERIDONE

DMF 269452013

MSN ORGANICS PRIVATE LTDILOPERIDONE [ROUTE CODE - "IO"]

DMF 270392013

LUPIN LTDILOPERIDONE

DMF 270772013

MYLAN LABORATORIES LTDInactiveILOPERIDONE

DMF 255772011

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Nov 30, 2016	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.