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Metronidazole - Generic Drug Details

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, Aurobindo Pharma Ltd, Cadila Pharms Ltd, Chartwell Molecules, Flamingo Pharms, Fosun Pharma, Halsey, Heritage Pharms Inc, Innogenix, Ivax Sub Teva Pharms, LNK, Lupin Ltd, Mutual Pharm, Orit Labs Llc, Pliva, Strides Pharma, Strides Vivimed, Superpharm, Teva Pharms Usa, Unichem Labs Ltd, 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. Ninety 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:	90
Bulk Api Vendors:	134
Clinical Trials:	354
Patent Applications:	7,480
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for metronidazole
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for metronidazole
DailyMed Link:	metronidazole at DailyMed

Pharmacology for metronidazole

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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Strides Vivimed	METRONIDAZOLE	metronidazole	TABLET;ORAL	070039-001	Jan 29, 1985	AB	RX	No	No	➤ Sign Up	➤ Sign Up				➤ Sign Up
Watson Labs	METRONIDAZOLE	metronidazole	INJECTABLE;INJECTION	070170-001	Apr 1, 1986		DISCN	No	No	➤ Sign Up	➤ Sign Up				➤ Sign Up
Savage Labs	SATRIC	metronidazole	TABLET;ORAL	070731-001	Jun 8, 1987		DISCN	No	No	➤ Sign Up	➤ Sign Up				➤ Sign Up
B Braun	METRO I.V. IN PLASTIC CONTAINER	metronidazole	INJECTABLE;INJECTION	018900-001	Sep 29, 1983	AP	RX	Yes	Yes	➤ Sign Up	➤ Sign Up				➤ Sign Up
Cadila Pharms Ltd	METRONIDAZOLE	metronidazole	TABLET;ORAL	209794-001	Dec 12, 2017	AB	RX	No	No	➤ Sign Up	➤ Sign Up				➤ Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration

Expired US Patents for metronidazole

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

International Patents for metronidazole

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Country	Document Number	Estimated Expiration
Japan	2017014248	➤ Sign Up
Russian Federation	2284810	➤ Sign Up
Canada	2470492	➤ Sign Up
Japan	5986632	➤ Sign Up
South Korea	20040075911	➤ Sign Up
Country	Document Number	Estimated Expiration

Supplementary Protection Certificates for metronidazole

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Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C0021	Belgium	➤ Sign Up	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
Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description