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Last Updated: October 23, 2019

DrugPatentWatch Database Preview

METROGEL Drug Profile

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Which patents cover Metrogel, and what generic alternatives are available?

Metrogel is a drug marketed by Galderma Labs Lp and Bausch and is included in three NDAs. There are two patents protecting this drug and two Paragraph IV challenges.

This drug has twenty-eight patent family members in nineteen countries.

The generic ingredient in METROGEL is metronidazole. There are eighteen drug master file entries for this compound. Seventy-seven suppliers are listed for this compound. Additional details are available on the metronidazole profile page.

Drug patent expirations by year for METROGEL
Drug Prices for METROGEL

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Drug Sales Revenue Trends for METROGEL

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Recent Clinical Trials for METROGEL

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SponsorPhase
National Institute of Allergy and Infectious Diseases (NIAID)Phase 2
ParexelPhase 2
Alfa Wassermann S.p.A.Phase 2

See all METROGEL clinical trials

Recent Litigation for METROGEL

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 METROGEL litigation

Pharmacology for METROGEL
Synonyms for METROGEL
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-Vaginal
Metrogel-vaginal (TN)
Metrogyl
Metrolag
MetroLotion
Metrolyl
Metromidol
Metronidaz
Metronidazol
Metronidazol [INN-Spanish]
metronidazole
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

US Patents and Regulatory Information for METROGEL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Galderma Labs Lp METROGEL metronidazole GEL;TOPICAL 019737-001 Nov 22, 1988 AB RX Yes Yes   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
Galderma Labs Lp METROGEL metronidazole GEL;TOPICAL 021789-001 Jun 30, 2005 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Galderma Labs Lp METROGEL metronidazole GEL;TOPICAL 021789-001 Jun 30, 2005 AB RX Yes Yes   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration
Paragraph IV (Patent) Challenges for METROGEL
Drugname Dosage Strength RLD Date
➤ Subscribe Topical Gel 1% ➤ Subscribe   Start Trial
➤ Subscribe Vaginal Gel 0.75% ➤ Subscribe   Start Trial

Supplementary Protection Certificates for METROGEL

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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