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Metronidazole - Generic Drug Details

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What are the generic drug sources for metronidazole and what is the scope of metronidazole freedom to operate?

Metronidazole is the generic ingredient in nineteen branded drugs marketed by Gd Searle Llc, Able, Alembic Pharms Ltd, Par Pharm, Galderma Labs Lp, Fougera Pharms, G And W Labs, Valeant Pharms North, G And W Labs Inc, Taro, Taro Pharm, Tolmar, Medicis, Chemo Research Sl, Teva Pharms, Baxter Hlthcare, Pfizer, B Braun, Abbott, Abraxis Pharm, Intl Medication, Watson Labs, West-ward Pharms Int, Baxter Hlthcare Corp, Hospira, Mylan Labs Ltd, Labs Af, Appco Pharma Llc, Aurobindo Pharma Ltd, Cadila Pharms Ltd, Chartwell Molecules, Flamingo Pharms, Fosun Pharma, Halsey, Innogenix, Ivax Sub Teva Pharms, LNK, Lupin Ltd, Mutual Pharm, Orit Labs Llc, Pliva, Strides Pharma, Superpharm, Teva Pharms Usa, Unichem Labs Ltd, Vivimed Global, Watson Labs Inc, Zydus Pharms Usa Inc, Ortho Mcneil Pharm, and Savage Labs, and is included in seventy-five NDAs. There are eight patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Metronidazole has forty-two patent family members in nineteen countries.

There are eighteen drug master file entries for metronidazole. Eighty-five suppliers are listed for this compound.

Summary for metronidazole

International Patents:	42
US Patents:	8
Tradenames:	19
Applicants:	50
NDAs:	75
Drug Master File Entries:	18
Suppliers / Packagers:	85
Bulk Api Vendors:	123
Clinical Trials:	310
Patent Applications:	7,499
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for metronidazole
DailyMed Link:	metronidazole at DailyMed

Pharmacology for metronidazole

Ingredient-type	Nitroimidazoles
Drug Class	Nitroimidazole Antimicrobial

Medical Subject Heading (MeSH) Categories for metronidazole

Anti-Infective Agents

Antiprotozoal Agents

Radiation-Sensitizing Agents

Synonyms for metronidazole

1-(.beta.-Ethylol)-2-methyl-5-nitro-3-azapyrrole

1-(.beta.-Hydroxyethyl)-2-methyl-5-nitroimidazole

1-(2-Hydroxy-1-ethyl)-2-methyl-5-nitroimidazole

1-(2-Hydroxyethyl)-2-methyl-5-nitroimidazole

1-(2-Hydroxyethyl)-2-methyl-5-nitroimidazole N-(5-carboxy-5-aminopentane)carbamate

1-(beta-Ethylol)-2-methyl-5-nitro-3-azapyrrole

1-(beta-Hydroxyethyl)-2-methyl-5-nitroimidazole

1-(beta-Oxyethyl)-2-methyl-5-nitroimidazole

1-hydrox yethyl-2-methyl-5-nitroimidazole

1-Hydroxyethyl-2-methyl-5-nitroimidazole

140QMO216E

1H-Imidazole-1-ethanol, 2-methyl-5-nitro-

2-(2-methyl-5-nitro-1-imidazolyl)ethanol

2-(2-methyl-5-nitro-1H-imidazol-1-yl)-1-ethanol

2-(2-methyl-5-nitro-1H-imidazol-1-yl)ethan-1-ol

2-(2-Methyl-5-nitro-1H-imidazol-1-yl)ethanol

2-(2-Methyl-5-nitro-1H-imidazol-1-yl)ethanol #

2-(2-Methyl-5-nitro-imidazol-1-yl)-ethanol

2-(2-methyl-5-nitro-imidazol-1-yl)ethanol

2-(2-methyl-5-nitroimidazol-1-yl)ethanol

2-(2-methyl-5-nitroimidazolyl)ethan-1-ol

2-Methyl-1-(2-hydroxyethyl)-5-nitroimidazole

2-Methyl-3-(2-hydroxyethyl)-4-nitroimidazole

2-Methyl-5-nitro-1-imidazoleethanol

2-Methyl-5-nitro-1H-imidazole-1-ethanol

2-Methyl-5-nitroimidazole-1-ethanol

443-48-1

5-23-05-00063 (Beilstein Handbook Reference)

69198-10-3 (mono-hydrochloride)

74568-EP2275420A1

74568-EP2292612A2

74568-EP2305640A2

74568-EP2305662A1

74568-EP2308857A1

A826552

AB00052046

AB00052046_18

AB00052046_19

AB00052046-17

AB0008438

AB2000365

AC-23968

AC1L1HKS

AC1Q2P2Z

ACMC-209jxc

Acromona

AJ-11436

AK-77146

AKOS000269646

AKOS005169650

AN-23451

Anabact (TN)

Anagiardil

ANW-30094

APMN

Apo-Metronidazole

Arilin

ARONIS24285

Atrivyl

BAS 02983617

BAY-5360

Bayer 5360

BAYER-5360

BB 0218386

BBL005452

BC200966

BCBcMAP01_000184

BDBM50375309

Bexon

BIDD:GT0107

Bio-0694

BPBio1_000004

BRD-K52020312-001-05-2

BRN 0611683

BSPBio_000002

BSPBio_002031

C07203

CAS-443-48-1

Caswell No. 579AA

CB-01-14 MMX

CCG-40016

CCRIS 410

CHEBI:6909

CHEMBL137

Cimetrol 500LPCI

CJ-00822

Clont

CONT

CPD000058175

CS-2358

CTK8B1704

D00409

D0A2ZX

Danizol

DB00916

Deflamon

Deflamon-wirkstoff

DivK1c_000007

DR000201

DSSTox_CID_892

DSSTox_GSID_20892

DSSTox_RID_75848

DTXSID2020892

Efloran

EINECS 207-136-1

Elyzol

Entizol

EPA Pesticide Chemical Code 120401

Eumin

F1773-0073

Flagemona

Flagesol

Flagil

Flagyl

Flagyl (TN)

Flagyl 375

Flagyl Er

Flagyl I.V.

Flagyl I.V. RTU

Flagyl I.V. RTU (Salt/Mix)

FLAGYL I.V. RTU IN PLASTIC CONTAINER

Flagyl, Filmet

Flazol

Flegyl

Florazole

Fossyol

FP-250

FT-0603394

Giatricol

Ginefla vir

Gineflavir

giniflavir

HE144513

HE421206

HE421207

HELIDAC (Salt/Mix)

HMS1568A04

HMS1920N19

HMS2051G07

HMS2090B19

HMS2091F14

HMS2095A04

HMS2231E11

HMS3373O05

HMS3393G07

HMS3655E22

HMS500A09

HMS547C19

HSDB 3129

HY-B0318

I14-0667

IDI1_000007

IDR-90105

Imidazole-1-ethanol, 2-methyl-5-nitro-

KB-279824

KB-55045

KB-91535

KBio1_000007

KBio2_001515

KBio2_004083

KBio2_006651

KBio3_001531

KBioGR_000559

KBioSS_001515

Klion

Klont

KS-00000GNW

KS-000048I4

KS-5140

KSC911O0J

lagyl

LS-1264

M-2794

M0924

Maybridge1_001999

MCULE-6891596695

Mepagyl

Meronidal

Methronidazole

Methyl-5-nitroimidazole-1-ethanol

Metric

Metric 21

Metro Cream

Metro cream & gel

Metro Gel

METRO I.V

Metro I.V.

Metro I.V. In Plastic Container

Metro IV

MetroCream

Metrodzhil

MetroGel

MetroGel (TN)

MetroGel-Vaginal

Metrogel-vaginal (TN)

Metrogyl

Metrolag

MetroLotion

Metrolyl

Metromidol

Metronidaz

Metronidazol

Metronidazol [INN-Spanish]

Metronidazole (Flagyl)

Metronidazole (JP15/USP/INN)

Metronidazole (JP17/USP/INN)

Metronidazole [USAN:INN:BAN:JAN]

Metronidazole [USAN:USP:INN:BAN:JAN]

Metronidazole 2.0 mg/ml in Methanol

Metronidazole in Plastic Container

Metronidazole Monohydrochloride

Metronidazole Phosphoester

Metronidazole solution, 2.0 mg/mL in methanol, ampule of 1 mL, certified reference material

METRONIDAZOLE USP

Metronidazole-(ethylene-d4)

Metronidazole, 99% 25g

Metronidazole, analytical standard

Metronidazole, Antibiotic for Culture Media Use Only

Metronidazole, BioXtra

Metronidazole, British Pharmacopoeia (BP) Reference Standard

Metronidazole, certified reference material, TraceCERT(R)

Metronidazole, European Pharmacopoeia (EP) Reference Standard

Metronidazole, pharmaceutical secondary standard; traceable to USP, PhEur and BP

Metronidazole, SAJ first grade, >=99.0%

Metronidazole, United States Pharmacopeia (USP) Reference Standard

Metronidazole, VETRANAL(TM), analytical standard

Metronidazole(Flagyl)

Metronidazolo

Metronidazolo [DCIT]

Metronidazolum

Metronidazolum [INN-Latin]

metropol

metrotab

Metrotop

Metrozine

Metryl

Mexibol

Mexibol 'silanes'

Mexibol (silanes)

MFCD00009750

MLS000028590

MLS000758286

MLS001424018

MNZ

MolPort-000-141-892

Monagyl

Monasin

Nalox

NC00020

NCGC00016446-01

NCGC00016446-02

NCGC00016446-03

NCGC00016446-04

NCGC00016446-05

NCGC00016446-06

NCGC00016446-07

NCGC00016446-08

NCGC00016446-09

NCGC00016446-11

NCGC00016446-12

NCGC00022059-03

NCGC00022059-04

NCGC00022059-05

NCGC00256513-01

NCGC00259962-01

NCIOpen2_000337

neo-Tric

NIDA

Nidagel

Nidagyl

nidazole

NINDS_000007

Noritate

Noritate (TN)

Novonidazol

NSC 50364

NSC 69587

NSC-50364

NSC-69587

NSC-757118

NSC50364

NSC69587

NSC757118

Opera_ID_1585

OR271196

Orvagil

Pharmakon1600-01500412

Polibiotic

Prestwick_334

Prestwick0_000081

Prestwick1_000081

Prestwick2_000081

Prestwick3_000081

Protostat

PubChem15970

Q-201403

Rathimed

Rosased

Rozex (TN)

RP 8823

RP-8823

RP02657

RTR-036813

s1907

SAM001247010

Sanatrichom

Satric

SBB001486

SBB041018

SBI-0051447.P003

SC 10295

SC-46607

SCHEMBL23042

SMP1_000189

SMR000058175

SPBio_000666

SPBio_001941

Spectrum_001035

SPECTRUM1500412

Spectrum2_000883

Spectrum3_000506

Spectrum4_000060

Spectrum5_001289

ST024769

ST24027485

STK177359

Takimetol

Tox21_110441

Tox21_110441_1

Tox21_202413

Tox21_302794

TR-036813

TRA0003669

Trichazol

Trichex

Tricho cordes

Tricho-gynaedron

Trichobrol

Trichocide

Trichomol

Trichomonacid 'pharmachim'

Trichomonacid pharmachim

Trichopal

Trichopol

Tricocet

Tricom

Tricowas B

Trikacide

Trikamon

Trikhopol

Trikojol

Trikozol

Trimeks

Trivazol

UNII-140QMO216E

Vagilen

Vagimid

Vandazole

VAOCPAMSLUNLGC-UHFFFAOYSA-N

Vertisal

Wagitran

WLN: T5N CNJ A2Q B1 ENW

WLN: T6NTJ DQ ANU1- ET5N CNJ A1 BNW

Z87001124

Zadstat

ZB003814

ZERO/004064

Zidoval

ZINC113442

US Patents and Regulatory Information for metronidazole

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Alembic Pharms Ltd	METRONIDAZOLE	metronidazole	TABLET;ORAL	079067-002	Mar 13, 2009	AB	RX	No	No
Labs Af	METROMIDOL	metronidazole	TABLET;ORAL	074523-001	Oct 24, 1996		DISCN	No	No
Able	METRONIDAZOLE	metronidazole	TABLET;ORAL	076519-002	Jun 27, 2003		DISCN	No	No
Chartwell Molecules	METRONIDAZOLE	metronidazole	TABLET;ORAL	018845-001	Aug 18, 1983		DISCN	No	No

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Expired US Patents for metronidazole

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Medicis	METROGEL-VAGINAL	metronidazole	GEL;VAGINAL	020208-001	Aug 17, 1992
Galderma Labs Lp	METROGEL	metronidazole	GEL;TOPICAL	019737-001	Nov 22, 1988
Gd Searle Llc	FLAGYL ER	metronidazole	TABLET, EXTENDED RELEASE;ORAL	020868-001	Nov 26, 1997
Medicis	METROGEL-VAGINAL	metronidazole	GEL;VAGINAL	020208-001	Aug 17, 1992

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International Patents for metronidazole

Country	Document Number	Estimated Expiration
Cyprus	1111095
Japan	6235087
Australia	2002340458
Spain	2352656

Supplementary Protection Certificates for metronidazole

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C0021	Belgium		PRODUCT NAME: LANSOPRAZOLE + CLARITHROMYCINE + METRONIDAZOLE; REGISTRATION NO/DATE IN FRANCE: K 27 17033R DU 19960209; REGISTRATION NO/DATE AT EEC: K 27 17033R DU 19960209