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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 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, 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.
Summary for metronidazole
| International Patents: | 44 |
| US Patents: | 9 |
| Tradenames: | 19 |
| Applicants: | 49 |
| NDAs: | 77 |
| Drug Master File Entries: | 18 |
| Suppliers / Packagers: | 75 |
| Bulk Api Vendors: | 141 |
| Clinical Trials: | 391 |
| Patent Applications: | 7,813 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price trends for metronidazole |
| Drug Sales Revenues: | Drug sales revenues for metronidazole |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for metronidazole |
| DailyMed Link: | metronidazole at DailyMed |
Recent Clinical Trials for metronidazole
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Universitaire Ziekenhuizen Leuven | Phase 3 |
| Canadian Institutes of Health Research (CIHR) | Phase 4 |
| Todd Lee | Phase 4 |
Recent Litigation for metronidazole
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Galderma Laboratories LP v. SEEGPharm SA | 2016-08-29 |
| Galderma Laboratories LP v. Tolmar Inc | 2009-03-03 |
Pharmacology for metronidazole
| Drug Class | Nitroimidazole Antimicrobial |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Chartwell Molecules | METRONIDAZOLE | metronidazole | TABLET;ORAL | 018930-001 | Aug 18, 1983 | DISCN | No | No | Start Trial | Start Trial | Start Trial | ||||
| Cadila Pharms Ltd | METRONIDAZOLE | metronidazole | TABLET;ORAL | 209794-001 | Dec 12, 2017 | AB | RX | No | No | Start Trial | Start Trial | Start Trial | |||
| Fougera Pharms | METRONIDAZOLE | metronidazole | GEL;TOPICAL | 077018-001 | Jun 6, 2006 | 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 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for metronidazole
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | 2017014248 | Start Trial |
| Japan | 6235087 | Start Trial |
| Canada | 2470492 | Start Trial |
| >Country | >Patent Number | >Estimated 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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2019, www.DrugPatentWatch.com.