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LINEZOLID

ANDA

LINEZOLID | A204536 | AMNEAL PHARMACEUTICALS

1 strength0 unique patents0 unique exclusivities

Hatch-Waxman Litigation

2 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
SYMED LABS LIMITED et al v. AMNEAL PHARMACEUTICALS LLC et al 2:2018cv13628 2 patentsANDA 204536linezolid	D.N.J.	2018-09-06	Terminated 2022-07-18	—
SYMED LABS LIMITED et al v. AMNEAL PHARMACEUTICALS LLC 2:2015cv08307 4 patentsANDA 204536linezolid	D.N.J.	2015-11-25	Terminated 2022-07-18	—

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

API Supply Chain28 active DMFs5 inactive

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

TAPI NL BVLINEZOLID

DMF 190322005

ALIVUS LIFE SCIENCES LTDLINEZOLID

DMF 197462006

SYMED LABS LTDLINEZOLID (FORM III)

DMF 202692007

NEULAND LABORATORIES LTDLINEZOLID USP (FORM-II)

DMF 245062010

ALEMBIC PHARMACEUTICALS LTDLINEZOLID USP

DMF 247902011

DR REDDYS LABORATORIES LTDLINEZOLID

DMF 254252011

FORMOSA LABORATORIES INCLINEZOLID

DMF 257002012

RAKS PHARMA PVT LTDLINEZOLID USP

DMF 260422012

JUBILANT PHARMOVA LTDLINEZOLID FORM 1

DMF 269282013

ZHEJIANG LEPU PHARMACEUTICAL CO LTDLINEZOLID (FORM I), NON-STERILE BULK DRUG SUBSTANCE

DMF 269622013

ZYDUS LIFESCIENCES LTDLINEZOLID

DMF 272332013

ALIVUS LIFE SCIENCES LTDLINEZOLID D111 PROCESS

DMF 274432013

ZHEJIANG HISUN PHARMACEUTICAL CO LTDLINEZOLID

DMF 285962014

SYMED LABS LTDLINEZOLID (FORM-II)

DMF 286422014

MACLEODS PHARMACEUTICALS LTDLINEZOLID

DMF 304862016

ALEMBIC PHARMACEUTICALS LTD API DIVLINEZOLID USP (FORM-I)

DMF 346482020

OPTIMUS DRUGS PRIVATE LTDLINEZOLID

DMF 351342020

CHROMO LABORATORIES INDIA PRIVATE LTDLINEZOLID USP

DMF 353042020

ALEMBIC PHARMACEUTICALS LTDLINEZOLID USP (FORM-II)

DMF 356072021

ZHEJIANG SUPOR PHARMACEUTICALS CO LTDLINEZOLID

DMF 358912021

ZHEJIANG CHANGHAI PHARMACEUTICALS CO LTDLINEZOLID USP (NON-STERILE API)

DMF 359382021

NEULAND LABORATORIES LTDLINEZOLID USP (PROCESS-II)

DMF 369462022

LEE PHARMA LTDLINEZOLID USP

DMF 377322022

GLAND PHARMA LTDLINEZOLID

DMF 377372022

CHONGQING HUAPONT PHARMACEUTICAL CO LTDLINEZOLID

DMF 379432023

OPTIMUS DRUGS PRIVATE LTDLINEZOLID USP (FORM-III)

DMF 411572024

APISYN HEALTHCARE PRIVATE LTDLINEZOLID (FORM-II)

DMF 423622025

APISYN HEALTHCARE PRIVATE LTDLINEZOLID (FORM-III)

DMF 423632025

APOTEX PHARMACHEM INDIA PVT LTDInactiveLINEZOLID

DMF 254922011

UNION QUIMICO FARMACEUTICA SA (UQUIFA SA)InactiveLINEZOLID

DMF 262002012

USV PRIVATE LTDInactiveLINEZOLID

DMF 267012012

AMOLI ORGANICS PVT LTDInactiveLINEZOLID [FORM-1]

DMF 275342013

AMOLI ORGANICS PVT LTDInactiveLINEZOLID [FORM-II]

DMF 276732013

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

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Dec 22, 2015	ORIG -1	View Letter (PDF)
May 28, 2015	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 600MG

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Dec 21, 2015

No patent or exclusivity listings for this strength.