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Metronidazole - Generic Drug Details
What are the generic 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, Strides Vivimed, 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.There are eighteen drug master file entries for metronidazole. Ninety suppliers are listed for this compound.
Summary for metronidazole
| US Patents: | 8 |
| Tradenames: | 19 |
| Applicants: | 51 |
| NDAs: | 75 |
| Drug Master File Entries: | 18 |
| Suppliers / Packagers: | 90 |
| Bulk Api Vendors: | 128 |
| Clinical Trials: | 335 |
| Patent Applications: | 7,491 |
| 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
| Ingredient-type | Nitroimidazoles |
| 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 |
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Chartwell Molecules | METRONIDAZOLE | metronidazole | TABLET;ORAL | 018930-001 | Aug 18, 1983 | DISCN | No | No | ➤ Try a Free Trial | ➤ Try a Free Trial | ➤ Try a Free Trial | ||||
| Mylan Labs Ltd | METRONIDAZOLE IN PLASTIC CONTAINER | metronidazole | INJECTABLE;INJECTION | 205531-001 | May 9, 2017 | AP | RX | No | No | ➤ Try a Free Trial | ➤ Try a Free Trial | ➤ Try a Free Trial | |||
| Flamingo Pharms | METRONIDAZOLE | metronidazole | TABLET;ORAL | 207309-002 | May 16, 2016 | AB | RX | No | No | ➤ Try a Free Trial | ➤ Try a Free Trial | ➤ Try a Free Trial | |||
| Galderma Labs Lp | METROGEL | metronidazole | GEL;TOPICAL | 021789-001 | Jun 30, 2005 | AB | RX | Yes | Yes | ➤ Try a Free Trial | ➤ Try a Free Trial | Y | ➤ Try a Free 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 |
|---|---|---|---|---|---|---|---|
| Gd Searle Llc | FLAGYL ER | metronidazole | TABLET, EXTENDED RELEASE;ORAL | 020868-001 | Nov 26, 1997 | ➤ Try a Free Trial | ➤ Try a Free Trial |
| Galderma Labs Lp | METROGEL | metronidazole | GEL;TOPICAL | 019737-001 | Nov 22, 1988 | ➤ Try a Free Trial | ➤ Try a Free Trial |
| Medicis | METROGEL-VAGINAL | metronidazole | GEL;VAGINAL | 020208-001 | Aug 17, 1992 | ➤ Try a Free Trial | ➤ Try a Free Trial |
| Medicis | METROGEL-VAGINAL | metronidazole | GEL;VAGINAL | 020208-001 | Aug 17, 1992 | ➤ Try a Free Trial | ➤ Try a Free Trial |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
International Patents for metronidazole
| Country | Document Number | Estimated Expiration |
|---|---|---|
| China | 1649603 | ➤ Try a Free Trial |
| European Patent Office | 2238980 | ➤ Try a Free Trial |
| China | 103763925 | ➤ Try a Free Trial |
| European Patent Office | 2725904 | ➤ Try a Free Trial |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for metronidazole
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| C0021 | Belgium | ➤ Try a Free 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 |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
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ISSN: 2162-2639
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Major Patent Expirations 2018 - 2019
Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2018, www.DrugPatentWatch.com.
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2018, www.DrugPatentWatch.com.
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