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LURASIDONE HYDROCHLORIDE

ANDA

LURASIDONE HYDROCHLORIDE | A208002 | AMNEAL PHARMACEUTICALS CO GMBH

5 strengths0 unique patents0 unique exclusivities

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
SUMITOMO DAINIPPON PHARMA CO., LTD. et al v. AMNEAL PHARMACEUTICALS LLC. 2:2016cv04596 1 patentANDA 208002lurasidone hydrochloride	D.N.J.	2016-07-29	Terminated 2019-02-04	—

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

API Supply Chain33 active DMFs1 inactive

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

DR REDDYS LABORATORIES LTDLURASIDONE HYDROCHLORIDE

DMF 267002013

ALIVUS LIFE SCIENCES LTDLURASIDONE HYDROCHLORIDE

DMF 274522013

MSN PHARMACHEM PRIVATE LTDLURASIDONE HYDROCHLORIDE [ROUTE CODE - LN"]

DMF 275702013

ALP PHARM BEIJING CO LTDLURASIDONE HYDROCHLORIDE

DMF 275842013

AMSA SPALURASIDONE HYDROCHLORIDE

DMF 278982014

LUPIN MANUFACTURING SOLUTIONS LTDLURASIDONE HYDROCHLORIDE

DMF 279632014

HETERO DRUGS LTDLURASIDONE HYDROCHLORIDE

DMF 279702014

MATRIX PHARMACORP PRIVATE LTDLURASIDONE HYDROCHLORIDE

DMF 281262014

TORRENT PHARMACEUTICALS LTDLURASIDONE HYDROCHLORIDE

DMF 281642014

TAPI NL BVLURASIDONE HYDROCHLORIDE

DMF 281782014

RAKS PHARMA PVT LTDLURASIDONE HYDROCHLORIDE

DMF 282522014

ZYDUS LIFESCIENCES LTDLURASIDONE HYDROCHLORIDE

DMF 282812014

SUN PHARMACEUTICAL INDUSTRIES LTDLURASIDONE HYDROCHLORIDE

DMF 284172014

INTAS PHARMACEUTICALS LTDLURASIDONE HYDROCHLORIDE

DMF 284472014

APITORIA PHARMA PRIVATE LTDLURASIDONE HYDROCHLORIDE

DMF 284482014

EDMOND PHARMA SRLLURASIDONE HYDROCHLORIDE

DMF 287232014

PIRAMAL PHARMA LTDLURASIDONE HYDROCHLORIDE

DMF 291632015

UNICHEM LABORATORIES LTDLURASIDONE HYDROCHLORIDE

DMF 291912015

NEULAND LABORATORIES LTDLURASIDONE HYDROCHLORIDE

DMF 297942016

ALEMBIC PHARMACEUTICALS LTDLURASIDONE HYDROCHLORIDE

DMF 300922015

SOLARA ACTIVE PHARMA SCIENCES LTDLURASIDONE HYDROCHLORIDE

DMF 304642016

JUBILANT PHARMOVA LTDLURASIDONE HYDROCHLORIDE

DMF 313802017

COHANCE LIFESCIENCES LTDLURASIDONE HYDROCHLORIDE

DMF 318012017

MACLEODS PHARMACEUTICALS LTDLURASIDONE HYDROCHLORIDE

DMF 319542017

HISUN PHARMACEUTICAL NANTONG CO LTDLURASIDONE HYDROCHLORIDE

DMF 320022017

PROCOS SPALURASIDONE HYDROCHLORIDE

DMF 338722019

MSN PHARMACHEM PRIVATE LTDLURASIDONE

DMF 340812019

METROCHEM API PRIVATE LTDLURASIDONE HYDROCHLORIDE

DMF 347562020

LEE PHARMA LTDLURASIDONE HYDROCHLORIDE

DMF 364922021

ALKEM LABORATORIES LTDLURASIDONE HYDROCHLORIDE

DMF 395702024

BIOCON LTDLURASIDONE HYDROCHLORIDE

DMF 395742024

MEGAFINE PHARMA P LTDLURASIDONE HYDROCHLORIDE

DMF 403752024

MICRO LABS LTDLURASIDONE HYDROCHLORIDE

DMF 405672024

APOTEX PHARMACHEM INDIA PVT LTDInactiveLURASIDONE HYDROCHLORIDE

DMF 280762014

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Feb 21, 2019	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.