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Last Updated: December 14, 2019

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Metronidazole - Generic Drug Details

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What are the generic sources for metronidazole and what is the scope of patent protection?

Metronidazole is the generic ingredient in nineteen branded drugs marketed by Gd Searle Llc, Able, Alembic Pharms Ltd, Par Pharm, Galderma Labs Lp, Acp Nimble, Fougera Pharms, Valeant Pharms North, Taro, Tolmar, Bausch, Perrigo Uk Finco, 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, Inforlife, Mylan Labs Ltd, Labs Af, Aurobindo Pharma Ltd, Cadila, 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, Superpharm, Teva Pharms Usa, Unichem Labs Ltd, Watson Labs Inc, Ortho Mcneil Pharm, and Savage Labs, and is included in seventy-seven NDAs. There are nine patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

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

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

Drug Prices for metronidazole

See drug prices for metronidazole

Drug Sales Revenue Trends for metronidazole

See drug sales revenues for metronidazole

Recent Clinical Trials for metronidazole

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Universitaire Ziekenhuizen LeuvenPhase 3
Canadian Institutes of Health Research (CIHR)Phase 4
Todd LeePhase 4

See all metronidazole clinical trials

Recent Litigation for metronidazole

Identify potential future generic entrants

District Court Litigation
Case NameDate
Galderma Laboratories LP v. SEEGPharm SA2016-08-29
Galderma Laboratories LP v. Tolmar Inc2009-03-03

See all metronidazole litigation

Pharmacology for metronidazole
Medical Subject Heading (MeSH) Categories for metronidazole
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
99616-64-5
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
Anagiardil
ANW-30094
Apo-Metronidazole
Arilin
ARONIS24285
Atrivyl
BAS 02983617
BAY-5360
Bayer 5360
BAYER-5360
BB 0218386
BBL005452
BC200966
BCBcMAP01_000184
BCP13757
BDBM50375309
Bexon
BIDD:GT0107
BPBio1_000004
BRD-K52020312-001-05-2
BRD-K52020312-001-15-1
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
Danizol
DB00916
Deflamon
Deflamon-wirkstoff
DivK1c_000007
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
HELIDAC (Salt/Mix)
HMS1568A04
HMS1920N19
HMS2051G07
HMS2090B19
HMS2091F14
HMS2095A04
HMS2231E11
HMS3373O05
HMS3393G07
HMS3655E22
HMS3712A04
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-Vaginal
Metrogel-vaginal (TN)
Metrogyl
Metrolag
MetroLotion
Metrolyl
Metromidol
Metronidaz
Metronidazol
Metronidazol [INN-Spanish]
Metronidazole (Flagyl)
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, 99%
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; Certified Reference Material
Metronidazole, SAJ first grade, >=99.0%
Metronidazole, United States Pharmacopeia (USP) Reference Standard
Metronidazole, VETRANAL(TM), analytical standard
Metronidazole,(S)
Metronidazole(Flagyl)
Metronidazolo
Metronidazolo [DCIT]
Metronidazolum
Metronidazolum [INN-Latin]
Metrotop
Metrozine
Metryl
Mexibol
Mexibol 'silanes'
MFCD00009750
MFCD00009750 (98%)
MLS000028590
MLS000758286
MLS001424018
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
NINDS_000007
Noritate
Noritate (TN)
Novonidazol
NSC 50364
NSC 69587
NSC-50364
NSC-69587
NSC-757118
NSC50364
NSC69587
NSC757118
Opera_ID_1585
Orvagil
Pharmakon1600-01500412
Polibiotic
Prestwick_334
Prestwick0_000081
Prestwick1_000081
Prestwick2_000081
Prestwick3_000081
Protostat
PubChem15970
Q-201403
Rathimed
Rosased
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
SR-01000000244
SR-01000000244-4
SR-01000000244-5
ST024769
ST24027485
STK177359
SW196613-4
SY002821
Takimetol
Tox21_110441
Tox21_110441_1
Tox21_202413
Tox21_302794
TR-036813
TRA0003669
Trichazol
Trichex
Tricho cordes
Tricho-gynaedron
Trichobrol
Trichocide
Trichomol
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
Paragraph IV (Patent) Challenges for METRONIDAZOLE
Tradename Dosage Ingredient NDA Submissiondate
METROGEL GEL;TOPICAL metronidazole 021789 2008-10-21
METROGEL-VAGINAL GEL;VAGINAL metronidazole 020208 2004-09-02

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
Acp Nimble METRONIDAZOLE metronidazole GEL;TOPICAL 078178-001 Jan 19, 2011 AB RX No No   Start Trial   Start Trial   Start Trial
Strides Pharma METRONIDAZOLE metronidazole TABLET;ORAL 208162-001 May 25, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Strides Pharma METRONIDAZOLE metronidazole TABLET;ORAL 070039-001 Jan 29, 1985 AB RX No No   Start Trial   Start Trial   Start Trial
Fosun Pharma METRONIDAZOLE metronidazole TABLET;ORAL 018620-002 Jun 2, 1983 DISCN No No   Start Trial   Start Trial   Start Trial
Tolmar METRONIDAZOLE metronidazole GEL;TOPICAL 090903-001 Jul 22, 2011 AB RX No No   Start Trial   Start Trial   Start Trial
Bausch METROGEL-VAGINAL metronidazole GEL;VAGINAL 020208-001 Aug 17, 1992 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Strides Pharma METRONIDAZOLE metronidazole TABLET;ORAL 208162-002 May 25, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
>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

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

Supplementary Protection Certificates for metronidazole

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0328535 96C0021 Belgium   Start Trial 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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