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Details for Generic Name: metronidazole

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Metronidazole is the generic ingredient in nineteen branded drugs marketed by Gd Searle Llc, Able, Alembic Ltd, Par Pharm, Galderma Labs Lp, Fougera Pharms, G And W Labs, Valeant Pharms North, G And W Labs Inc, Taro, Tolmar, Medicis, Actavis Labs Ut Inc, Teva Pharms, Baxter Hlthcare, Pfizer, B Braun, Abbott, Abraxis Pharm, Hikma Maple , Intl Medication, Watson Labs, Claris Pharmaservice, Hospira, Labs Af, Alembic Pharms Ltd, Aurobindo Pharma Ltd, Halsey, Ivax Sub Teva Pharms, LNK, Mutual Pharm, Pliva, Sandoz, Superpharm, Teva Pharms Usa, Unichem Labs Ltd, Vivimed Labs, Watson Labs Inc, Ortho Mcneil Pharm, and Savage Labs, and is included in sixty-seven NDAs. There are seven patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has thirty-three patent family members in eighteen countries.

There are eighteen drug master file entries for metronidazole. Twenty-two suppliers are listed for this compound.

Summary for Generic Name: metronidazole

Tradenames:19
Patents:7
Applicants:40
NDAs:67
Drug Master File Entries: see list18
Suppliers / Packaging: see list67
Therapeutic Class:Antibacterials
Formulation / Manufacturing:see details

Pharmacology for Ingredient: metronidazole

Clinical Trials for: metronidazole

A Safety, Tolerability and Pharmacokinetic Study of Two Formulations of Metronidazole Versus Immediate Release Metronidazole in Patient With C. Difficile Colitis
Status: Completed Condition: Clostridium Difficile Associated Diarrhea

Penicillin and Metronidazole in Treatment of Peritonsillar Abscess
Status: Completed Condition: Peritonsillar Abscess

A Study to Assess the Levels of CAZ-AVI and Metronidazole in the Blood When Given Together and Separately
Status: Completed Condition: Healthy

Comparison Between Oral Clindamycin Vs Metronidazole for the Treatment of Abnormal Vaginal Flora in High Risk Pregnancies
Status: Recruiting Condition: Abnormal Vaginal Flora; Clindamycin Vs Metronidazole; High Risk Pregnancies for Preterm Labor

Effectiveness of Metronidazole in Pain Control Posthemorrhoidectomy
Status: Completed Condition: Hemorrhoids

Efficacy of Metronidazole Prophylaxis Against Clostridium Difficile-Associated Diarrhea in High Risk Adult Patients
Status: Recruiting Condition: Clostridium Difficile Diarrhea

A Phase 3 Study Of Intravenous Metronidazole For Intrabdominal Infection
Status: Completed Condition: Intra-abdominal Infections

Azithromycin Based Therapy for Induction of Remission in Active Pediatric Crohn's Disease
Status: Recruiting Condition: Crohn's Disease

Safety and Tolerability of Metronidazole Gel 1.3%
Status: Recruiting Condition: Vaginosis, Bacterial

Radiotherapy + Metronidazole vs Radiotherapy Alone In Improving Treatment Outcomes in Advanced Cervical Cancer in Uganda
Status: Completed Condition: Cervix Carcinoma

Metronidazole Drug Interaction Study With MMX® Mesalazine/Mesalamine
Status: Completed Condition: Healthy

Metronidazole Pharmacokinetics (PK) in Premature Infants
Status: Completed Condition: Serious Systemic Infections; Necrotizing Enterocolitis

A Trial of Standard vs Half Dose Rabeprazole, Clarithromycin, Metronidazole and Amoxicillin in the Treatment of Helicobacter Pylori Infection
Status: Completed Condition: Helicobacter Infections

Topical Metronidazole and Miconazole Co-formulated Vaginal Suppositories for Preventing Vaginal Infections in HIV-seronegative Women
Status: Completed Condition: Bacterial Vaginosis; Candidiasis; Trichomoniasis

Efficacy and Safety Study of Metronidazole, Nystatin and Dexamethasone Combination Therapy in Bacterial and Fungal Vaginal Infections
Status: Not yet recruiting Condition: Bacterial Vaginosis; Fungal Vaginal Infections

Full-mouth Periodontal Debridement and Metronidazole Gel in Patients With Chronic Periodontitis
Status: Completed Condition: Chronic Periodontitis

Bioequivalence of Metronidazole Gel, 0.75% in the Treatment of Bacterial Vaginosis
Status: Completed Condition: Bacterial Vaginosis

Odor Management in Fungating Wounds Comparing Metronidazole and Polihexanide
Status: Recruiting Condition: Neoplasm; Wounds and Injuries

Comparison of Moxifloxacin With Ciprofloxacin/Metronidazole on Patients With Chronic Periodontitis
Status: Completed Condition: Chronic Periodontitis

A Study To Assess The Safety, Tolerability And Pharmacokinetics Of Metronidazole Injection In Healthy Japanese Subjects
Status: Completed Condition: Infection

Treatment Study of Metronidazole to Treat Dientamoebiasis in Children
Status: Completed Condition: Dientamoebiasis

Clarithromycin, Amoxicillin, and Metronidazole Based Regimens to Treat Helicobacter Pylori Infections in Colombia
Status: Completed Condition: Helicobacter Pylori Infection

Evaluation of Topical 10% Metronidazole Ointment for the Treatment of Active Perianal Crohn's Disease
Status: Completed Condition: Crohn's Disease

CD5024 1% Cream Versus Metronidazole 0.75% Cream in Papulopustular Rosacea (PPR) Study
Status: Completed Condition: Papulopustular Rosacea

Increased Re-eradication Rate of Helicobacter Pylori by Adding N-acetylcystein or Metronidazole to the Triple Therapy
Status: Recruiting Condition: Bacterial Infection Due to Helicobacter Pylori (H. Pylori)

Safety and Efficacy Study to Compare IV CXA 101/Tazobactam and Metronidazole With Meropenem in Complicated Intraabdominal Infections
Status: Completed Condition: Complicated Intra-abdominal Infection

Antibiotic Treatment Trial for Small Intestinal Bacterial Overgrowth
Status: Enrolling by invitation Condition: Small Intestinal Bacterial Overgrowth

BASIC (Boric Acid, Alternate Solution for Intravaginal Colonization) Study
Status: Recruiting Condition: Bacterial Vaginosis

Compare Ceftazidime-Avibactam + Metronidazole Versus Meropenem for Hospitalized Adults With Complicated Intra-Abdominal Infections
Status: Completed Condition: Complicated Intra-Abdominal Infection

Compare Ceftazidime-Avibactam + Metronidazole vs Meropenem for Hospitalized Adults With Complicated Intra-Abd Infections
Status: Completed Condition: Complicated Intra-abdominal Infection

Bioavailability of Metronidazole Vaginal Gel in Healthy Subjects
Status: Completed Condition: Healthy

Adalimumab on Preventing Post-chirurgic Recurrence on Crohn´s Disease
Status: Completed Condition: Crohn´s Disease

MTZ Plus AMX in the Treatment of Smokers and Non-smokers
Status: Completed Condition: Chronic Periodontitis; Smoking

A Therapeutic Equivalence Study of Two Metronidazole 1%Topical Gel Treatments for Patients With Rosacea
Status: Completed Condition: Rosacea

Amoxicillin/Metronidazole Based Quadruple Therapy for Helicobacter Pylori Eradication
Status: Completed Condition: Dyspepsia; Peptic Ulcer

Efficacy of Metronidazole Versus Metronidazole and Rifampin in CDAD Treatment
Status: Completed Condition: Clostridium Enterocolitis; Antibiotic-Associated Diarrhea; Pseudomembranous Colitis; Pseudomembranous Enterocolitis; Pseudomembranous Enteritis

Effects of the Variation in the Time of Systemic Administration of Metronidazole and Amoxicillin Associated to the Non-surgical Therapy of Chronic Periodontitis.
Status: Recruiting Condition: Chronic Periodontitis; Clinical and Microbiological Effects

A Trial Comparing Moxifloxacin Versus Levofloxacin Plus Metronidazole In Uncomplicated Pelvic Inflammatory Disease
Status: Completed Condition: Pelvic Inflammatory Disease

Role of N-Acetylcysteine in Treatment of Bacterial Vaginosis
Status: Recruiting Condition: Bacterial Vaginosis

Evaluation of Safety,Pharmacokinetics and Efficacy of CAZ-AVI With Metronidazole in Childern Aged 3 Months to 18 Years Old With Complicated Intra-abdominal Infections (cIAIs)
Status: Not yet recruiting Condition: Complicated Intra-abdominal Infections (cIAIs)

A Pilot Study of Vancomycin or Metronidazole in Patients With Primary Sclerosing Cholangitis
Status: Completed Condition: Primary Sclerosing Cholangitis

Moxifloxacin Plus Metronidazole Versus Piperacillin/Tazobactam for the Treatment of Patients With Intra-abdominal Abscesses
Status: Recruiting Condition: Abscess, Intra-Abdominal

A Therapeutic Equivalence Study of Two Metronidazole Gel 1% Topical Treatments of Rosacea
Status: Recruiting Condition: Papulopustular Rosacea; Erythematotelangiectatic Rosacea

Study to Determine the Equivalence of Two Products Containing Metronidazole Benzoate
Status: Completed Condition: Healthy

Alternative Antibiotic Regime in the Treatment of GAgP
Status: Completed Condition: Generalized Aggressive Periodontitis; Aggressive Periodontitis

Study of Antibiotics in the Treatment of Colonic Crohn's Disease
Status: Terminated Condition: Crohn's Disease

An Evaluation of the Cosmetic Appearance of Metronidazole Gel (MetroGel®) 1%
Status: Completed Condition: Rosacea

Orally Administered Trimethoprim-sulfamethoxazole and Metronidazole as Prophylaxis of Infection Following Elective Colorectal Surgery
Status: Completed Condition: Infection Prophylaxis in Colo Rectal Surgery

Efficacy of Topical Azelaic Acid 15% Gel Plus Anti-inflammatory Dose Doxycycline or Metronidazole Gel 1% Plus Anti-inflammatory Dose Doxycycline in Moderate Papulopustular Rosacea
Status: Completed Condition: Papulopustular Rosacea

Metronidazole for Pulmonary Tuberculosis (South Korea)
Status: Completed Condition: Tuberculosis; Multi-Drug Resistant Tuberculosis

A Randomised Controlled Trial of the Use of Topical Metronidazole (10%) to Reduce Pain After Haemorrhoidectomy
Status: Completed Condition: Haemorrhoidectomy

A Study Comparing Ceftazidime-Avibactam+Metronidazole Versus Meropenem in Adults With Complicated Intra-abdominal Infections
Status: Completed Condition: Complicated Intra-Abdominal Infection

Impact of Oral Antibiotic Treatment on C. Difficile
Status: Recruiting Condition: C. Difficile; Diarrhea; Enterocolitis

Recurrent Bacterial Vaginosis and Vaginal Acidifying Gel Trial
Status: Completed Condition: Bacterial Vaginosis

Safety and Efficacy of Single Daily Dose of Ceftriaxone and Metronidazole for Treatment of Complicated Appendicitis in Children
Status: Completed Condition: Complicated Appendicitis

The Use of Erythritol Powder and Metronidazole Gel for the Non-surgical Treatment of Periodontitis
Status: Recruiting Condition: Periodontal Pocket

Efficacy and Safety of Ertapenem Sodium (MK-0826) Following Colorectal Surgery in Chinese Adults (MK-0826-056)
Status: Completed Condition: Infection; Surgical Site Infection

A Study to Evaluate the Safety and Effectiveness of Ertapenem Versus Ceftriaxone/Metronidazole in the Treatment of Intra-abdominal Infections in Adults (0826-802)
Status: Completed Condition: Intra-abdominal Infection

Inflammation and Treatment of Bacterial Vaginosis Near Term
Status: Recruiting Condition: Bacterial Vaginosis

Split-Face Tolerability Comparison Between MetroGel® 1% Versus Finacea® 15% in Subjects With Healthy Skin
Status: Completed Condition: Skin Manifestations

Bioavailability Study of Metronidazole Capsules Under Fed Conditions
Status: Completed Condition: To Determine the Bioequivalence Study Under Fed

Study to Determine the Equivalence of Three Products Containing Metronidazole Benzoate.
Status: Completed Condition: Bacterial Infections

Bioavailability Study of Metronidazole Capsules Under Fasting Conditions
Status: Completed Condition: To Determine the Bioequivalence Study Under Fasting

Split-face Tolerability Comparison Between MetroGel® 1% vs Finacea® 15% in Subjects With Healthy Skin
Status: Completed Condition: Skin Manifestations

Dose Ranging Study of Metronidazole Vaginal Gel in the Treatment of Bacterial Vaginosis
Status: Completed Condition: Vaginosis, Bacterial; Vaginal Infection

Treatment of Demodex Blepharitis With Ivermectin Gel 0.1% Plus Metronidazole 1%
Status: Completed Condition: Chronic Blepharitis

Prevention of Persistence of Bacterial Vaginosis
Status: Terminated Condition: Bacterial Vaginosis

IMT for Primary Clostridium Difficile Infection
Status: Recruiting Condition: Clostridium Difficile Infection

Evaluation of Relapse, Efficacy and Safety of Long-term Treatment With Oracea® vs Placebo
Status: Completed Condition: Rosacea

The Impact of Obesity on Nonsurgical Periodontal Therapy
Status: Recruiting Condition: Periodontitis; Periodontal Diseases; Obesity

Evaluation of the Pharmacokinetics of Metronidazole 10% Ointment Applied Peri Anally in Healthy Volunteers and Patients With Perianal Crohn's Disease
Status: Completed Condition: Perianal Crohns'

A Study to Compare Efficacy and Safety of an Ovule Containing Terconazole, Clindamycin and Fluocinolone Versus an Ovule Containing Metronidazole, Nystatin and Fluocinolone in the Treatment of Secondary Vulvar/ or Vaginal Symptoms of Infectious Vaginitis/ and Infectious Vaginosis
Status: Completed Condition: Vaginitis; Infectious Vaginosis

Rifaximin and Placebo in the Treatment of Bowel Dysfunction After Anterior Resection for Rectal Cancer
Status: Active, not recruiting Condition: Rectal Cancer

Antibiotic Safety (SCAMP)
Status: Recruiting Condition: Complicated Intra Abdominal Infections

Does Fidaxomicin Therapy Reduce Spread of Clostridium Difficile?
Status: Recruiting Condition: Clostridium Difficile Infection

Pharmacokinetic Interaction Study Between Budesonide and Metronidazole in Healthy Volunteers
Status: Completed Condition: Healthy

A Phase II Study of PROSTVAC-V (Vaccinia)/TRICOM and PROSTVAC-F (Fowlpox)/TRICOM With GM-CSF in Patients With PSA Progression After Local Therapy for Prostate Cancer
Status: Completed Condition: Recurrent Prostate Carcinoma; Stage I Prostate Cancer; Stage IIA Prostate Cancer; Stage IIB Prostate Cancer; Stage III Prostate Cancer

Study Comparing Tigecycline Versus Ceftriaxone Sodium Plus Metronidazole in Complicated Intra-abdominal Infection (cIAI)
Status: Completed Condition: Appendicitis; Cholecystitis; Diverticulitis; Intra-Abdominal Abscess; Intra-Abdominal Infection; Peritonitis

Study of Dexamethasone-Allantoin-Metronidazole (DAM) Solution in the Treatment of Post-Operative Ileus (POI)
Status: Recruiting Condition: Postoperative Ileus

Study Comparing Tigecycline Versus Ceftriaxone Sodium Plus Metronidazole in Complicated Intra-abdominal Infection
Status: Completed Condition: Appendicitis; Cholecystitis; Cross Infection; Diverticulitis; Peritonitis

Randomized Controlled Trial of Treatment of Male Partners of Women With BV
Status: Recruiting Condition: Recurrent Bacterial Vaginosis

Efficacy and Safety of Quadruple Therapy in Eradication of H. Pylori: A Comparison to Triple Therapy
Status: Completed Condition: Helicobacter Infections

Trichomonas Vaginalis Recurrence Among HIV+ Women
Status: Completed Condition: Trichomonas Infections; HIV Infections

Multi-center Clinical Study of Early Antibios of Severe Acute Pancreatitis
Status: Recruiting Condition: Pancreatitis,Acute Necrotizing

Do Motion Metrics Lead to Improved Skill Acquisition on Simulators?
Status: Completed Condition: Performance Assessment; Motion Metrics

Efficacy Study of Preconception Treatment of an Asymptomatic Bacterial Infection in an Infertility Population
Status: Terminated Condition: Vaginosis, Bacterial; Infertility; Miscarriage

Docetaxel and Prednisone With or Without Vaccine in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer
Status: Active, not recruiting Condition: Adenocarcinoma of the Prostate; Castrate-resistant Metastatic Prostate Cancer

Comparison of the Eradications Rates of Sequential Therapy Versus Concomitant Therapy
Status: Recruiting Condition: Helicobacter Pylori Infection

Effects and Safety of Metronidazole in Patients With Gastrectomy
Status: Active, not recruiting Condition: Post Gastrectomy State

MATER Study: A Study of Metronidazole Cream in the Prevention and Treatment of Tarceva (Erlotinib)-Associated Rash
Status: Completed Condition: Non-Squamous Non-Small Cell Lung Cancer

Multi-Center Study of New Medications to Treat Vaginal Infections
Status: Recruiting Condition: Vaginal Infection

Response of Clostridium Difficile Infection to Metronidazole Therapy
Status: Completed Condition: Clostridium Enterocolitis; Pseudomembranous Colitis; Antibiotic-Associated Colitis

Comparison Between Ten Days Sequential Treatment and Traditional Three Combined Treatment of Helicobacter Pylori
Status: Completed Condition: Helicobacter Pylori Infection

Safety and Efficacy Study to Compare Two Rosacea Treatment Regimens
Status: Completed Condition: Rosacea

Assess the Ability of MetroGel 1% to Deliver Moisture to Facial Skin After a Single Application
Status: Completed Condition: Rosacea

Metronidazole and Amoxicillin for the Treatment of Type 2 Diabetic Subjects With Periodontitis
Status: Active, not recruiting Condition: Periodontitis

A Study Comparing Safety and Efficacy of Levofloxacin and Metronidazole Versus Piperacillin/Tazobactam in Treating Complicated Appendicitis
Status: Terminated Condition: Appendicitis

Is it Effective to Treat Patients With Blastocystis Hominis Infection?
Status: Recruiting Condition: Blastocystis Hominis Infections

Study of Metronidazole and Doxycycline to Treat Oral Lichen Planus and to Compare Their Efficacy With Each Other
Status: Completed Condition: Oral Lichen Planus

Tumescent Antibiotic Delivery Pharmacokinetics
Status: Completed Condition: Prevention of Surgical Site Infections

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Unichem Labs Ltd
METRONIDAZOLE
metronidazole
TABLET;ORAL203458-001Jan 22, 2014RXNo<disabled><disabled>
Taro
METRONIDAZOLE
metronidazole
GEL;TOPICAL077819-001Jul 18, 2006RXNo<disabled><disabled>
Lnk
METRONIDAZOLE
metronidazole
TABLET;ORAL019029-001Apr 10, 1984DISCNNo<disabled><disabled>
Ortho Mcneil Pharm
PROTOSTAT
metronidazole
TABLET;ORAL018871-001Mar 2, 1983DISCNNo<disabled><disabled>
Par Pharm
METRONIDAZOLE
metronidazole
CAPSULE;ORAL076522-001Jan 29, 2004RXNo<disabled><disabled>
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International Patent Family for Ingredient: metronidazole

Country Document Number Publication Date
South Korea20040075911Aug 30, 2004
Spain2352656Feb 22, 2011
Canada2470492Jul 17, 2003
Argentina037755Dec 01, 2004
China1649603Aug 03, 2005
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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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