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Profile for Tradename: METFORMIN HYDROCHLORIDE

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Metformin Hydrochloride is a drug marketed by Actavis Elizabeth, Actavis Labs Fl Inc, Amneal Pharms Ny, Apotex, Aurobindo Pharma Ltd, Barr, Cspc Ouyi Pharm Co, Impax Labs, Inventia Hlthcare, Ivax Sub Teva Pharms, Lupin Ltd, Mutual Pharm, Mylan, Mylan Pharms Inc, Nostrum Pharms Llc, Ranbaxy Labs Ltd, Sandoz, Sun Pharm Inds (in), Teva, Torrent Pharm, Torrent Pharms Ltd, Watson Labs Inc, Zydus Pharms Usa, Alkem, Atlas Pharms Llc, Aurobindo, Chartwell Life Sci, Dr Reddys Labs Inc, Glenmark Generics, Granules India, Indicus Pharma, Ipca Labs Ltd, Marksans Pharma, Mutual Pharma, Provident Pharm, Sciegen Pharms Inc, Sun Pharm Inds Inc, Torrent Pharms, Watson Labs, Watson Labs Florida, and Zydus Hlthcare. and is included in sixty-four NDAs.

The generic ingredient in METFORMIN HYDROCHLORIDE is metformin hydrochloride. There are forty-six drug master file entries for this compound. Eight suppliers are listed for this compound. There are three tentative approvals for this compound. Additional details are available on the metformin hydrochloride profile page.

Summary for Tradename: METFORMIN HYDROCHLORIDE

Patents:0
Applicants:41
NDAs:64

Clinical Trials for: METFORMIN HYDROCHLORIDE

Metformin Hydrochloride and Aspirin in Treating Patients With Hormone-Dependent Prostate Cancer That Has Progressed After Surgery or Radiation Therapy
Status: Not yet recruiting Condition: Recurrent Prostate Carcinoma; Stage I Prostate Cancer; Stage IIA Prostate Cancer; Stage IIB Prostate Cancer; Stage III Prostate Cancer

Evaluate Adherence to Treatment With Glucophage Sachets Versus Tablets in Diabetes Type 2 Patients Previously Treated With Metformin Tablets
Status: Withdrawn Condition: Diabetes Mellitus Type 2

Clinical Trial to Evaluate Safety and pK Profile of Metformin Glycinate in Healthy Volunteers
Status: Completed Condition: Healthy

A Study to Evaluate the Effect of Multiple Doses of Isavuconazole on the Pharmacokinetics of Metformin
Status: Completed Condition: Pharmacokinetics of Isavuconazole; Pharmacokinetics of Metformin; Healthy Subjects

Crossover Study to Evaluate the Comparative Bioavailability of Two Fixed Dose Combination Tablet Formulations of Extended Release Metformin and Extended Release Glimepiride in Health Volunteers
Status: Terminated Condition: Diabetes Mellitus, Type 2

A Study Comparing the Amount of Metformin and After Taking a Combination Tablet vs. Separate Tablets
Status: Completed Condition: Healthy Volunteers

Bioequivalence Study of 2.5-mg Saxagliptin and 500-mg Glucophage in Tablets and a Fixed-dose Combination Tablet in Healthy Participants
Status: Completed Condition: Type 2 Diabetes Mellitus

Safety and Tolerability of Trospium Chloride and Metformin Hydrochloride in Healthy Subjects
Status: Completed Condition: Healthy

An Extension Protocol to Evaluate Dose Comparisons of Leucine-Metformin Combinations in Type 2 Diabetic Patients
Status: Recruiting Condition: Type 2 Diabetes Mellitus

Bioequivalence Study of Two Formulations of 500 mg Metformin Extended Release Tablet
Status: Completed Condition: Metformin XR BE Study in Healthy Volunteers With Single and Multiple Dose

A Study to Demonstrate the Bioequivalence of Sitagliptin/Metformin Combination Tablets and Co-administration of Sitagliptin and Metformin as Individual Tablets (0431A-095)
Status: Completed Condition: Type 2 Diabetes

Gemcitabine Hydrochloride, Paclitaxel Albumin-Stabilized Nanoparticle Formulation, Metformin Hydrochloride, and a Standardized Dietary Supplement in Treating Patients With Metastatic Pancreatic Cancer
Status: Not yet recruiting Condition: Metastatic Pancreatic Adenocarcinoma; Stage IV Pancreatic Cancer

Study of Metformin With Simvastatin for Men With Prostate Carcinoma
Status: Recruiting Condition: Prostate Carcinoma

Reducing Antipsychotic-Induced Weight Gain in Children With Metformin
Status: Recruiting Condition: Obesity; Weight Gain; Psychotropic Induced Weight Gain

Comparison of PK After Administration of HCP1201 and Co-administration of Metformin SR 750mg and Rosuvastatin 20mg
Status: Completed Condition: Diabetes Mellitus

Comparison of PK After Administration of HCP1201 and Co-administration of Metformin SR 500mg and Rosuvastatin 10mg
Status: Completed Condition: Diabetes Mellitus

BE Study of the Fixed Dose Combination of 5 mg Saxagliptin and 500 mg Metformin HCl XR Tablet Relative to a 5 mg Saxagliptin (Onglyza™) Tablet and a 500 mg Metformin HCl XR (Glifage® XR Marketed in Brazil by Merck S.A.) Tablet Co-Administered to Healthy Subjects in the Fasted and Fed States
Status: Withdrawn Condition: Type 2 Diabetes

Sibutramine-metformin Combination Versus Sibutramine and Metformin Monotherapy in Obese Patients
Status: Active, not recruiting Condition: Obesity

Bioequivalence Study of Metformin Hydrochloride Tablets 1000 mg Tablets of Dr. Reddy's Laboratories Limited Under Fed Condition
Status: Completed Condition: Healthy

Bioequivalence Study of the Fixed Dose Combination of 5 mg Saxagliptin and 500 mg Metformin XR Tablet (Manufactured in Mt Vernon, IN) Relative to 5 mg Saxagliptin Tablet and 500 mg Metformin XR Tablet (Manufactured in Evansville, IN)
Status: Completed Condition: Diabetes Mellitus

Dose Comparisons of Leucine-Metformin Combinations on Blood Glucose Levels In Type 2 Diabetic Patients
Status: Active, not recruiting Condition: Type 2 Diabetes Mellitus

Metformin in Non Small Cell Lung Cancer (NSCLC)
Status: Recruiting Condition: Lung Cancer

Bioequivalence Study of Metformin Hydrochloride Tablets 1000 mg Tablets of Dr. Reddy's Laboratories Limited Under Fasting Condition
Status: Completed Condition: Healthy

Metformin for the Treatment of Endometrial Hyperplasia
Status: Recruiting Condition: Endometrial Hyperplasia; Endometrial Hyperplasia Without Atypia

Drug-Drug Interaction Study With Metformin and Nizatidine
Status: Completed Condition: Healthy

Stereotactic Radiosurgery and Metformin Hydrochloride in Treating Patients With Borderline-Resectable or Locally-Advanced Pancreatic Cancer
Status: Recruiting Condition: Acinar Cell Adenocarcinoma of the Pancreas; Duct Cell Adenocarcinoma of the Pancreas; Recurrent Pancreatic Cancer; Stage I-III Pancreatic Cancer

The Metformin-FMD Trial
Status: Completed Condition: Ischemia Reperfusion Injury; Endothelial Function

Study to Assess Safety and Pharmacokinetics of Double-Blind S-707106 Alone and in Combination With Open-Label Metformin in Patients With Type 2 Diabetes Mellitus
Status: Completed Condition: Type 2 Diabetes Mellitus

A Study of Metformin With or Without Rapamycin as Maintenance Therapy After Induction Chemotherapy in Subjects With Pancreatic Cancer
Status: Recruiting Condition: Metastatic Pancreatic Adenocarcinoma

Metformin Hydrochloride in Treating Patients With Prostate Cancer Undergoing Surgery
Status: Completed Condition: Adenocarcinoma of the Prostate; Recurrent Prostate Cancer; Stage I Prostate Cancer; Stage IIA Prostate Cancer; Stage IIB Prostate Cancer

Comparison of PK After Administration of HCP1201 and Co-administration of Metformin SR 750mg and Rosuvastatin 10mg
Status: Completed Condition: Diabetes Mellitus

An Open Study to Evaluate Whether Pack Size Affects Compliance of Metformin Treatment in Subjects With Type II Diabetes
Status: Terminated Condition: Diabetes Mellitus, Type 2

Safety of Continuing Metformin in Diabetic Patients With Normal Kidney Function Receiving Contrast Media
Status: Completed Condition: Diabetes Mellitus; Lactic Acidosis

Metformin Hydrochloride vs. Placebo in Overweight or Obese Patients at Elevated Risk for Breast Cancer
Status: Recruiting Condition: Breast Cancer; Obesity

Spironolactone Plus Metformin in Polycystic Ovary Syndrome
Status: Completed Condition: Polycystic Ovary Syndrome

Metformin-Dipyridamole Interaction Trial
Status: Completed Condition: Diabetes

Evaluating of Pharmacokinetic Profile of BCWP_C001 and Co-administration of Rosuvastatin and Metformin
Status: Not yet recruiting Condition: Healthy

Bioequivalence Study of Fixed Dose Combination of 2.5 mg Saxagliptin/850 mg Metformin Tablet Relative to 2.5 mg Onglyza and 850 mg Glucophage Tablets Co-Administered
Status: Completed Condition: Type 2 Diabetes Mellitus

A Trial of Metformin for Colorectal Cancer Risk Reduction Among Patients With a History of Colorectal Adenomas and Elevated Body Mass Index
Status: Completed Condition: Adenomatous Polyp; Colorectal Cancer; Obesity

Impact of Pretreatment With Metformin on Colorectal Cancer Stem Cells (CCSC) and Related Pharmacodynamic Markers
Status: Terminated Condition: Colon Cancer

Drug-drug Interaction Between Digoxin, Furosemide, Metformin, and Rosuvastatin
Status: Completed Condition: Healthy

Bioequivalence Study for Acarbose / Metformin FDC
Status: Completed Condition: Diabetes Mellitus, Type II

Metabolic Effects of a Caloric Restriction High/Low Glycemic Index Diet Plus Metformin in Overweight/Obese Subjects
Status: Completed Condition: Obesity

Evaluating a Pharmacokinetic Drug Interaction Between Metformin Hydrochloride and Rosuvastatin Calcium
Status: Completed Condition: Diabetes Mellitus

Metformin Hydrochloride in Treating Patients With Pancreatic Cancer That Can be Removed by Surgery
Status: Withdrawn Condition: Stage IA Pancreatic Cancer; Stage IB Pancreatic Cancer; Stage IIA Pancreatic Cancer; Stage IIB Pancreatic Cancer

Efficacy and Safety of Alogliptin Plus Metformin in Patients With Type 2 Diabetes
Status: Completed Condition: Diabetes Mellitus, Type 2

A Study to Explore Pharmacokinetic Interaction Between Rilpivirine and Metformin in Healthy Participants
Status: Completed Condition: Healthy Participants

Single Cohort, 2-Period Study to Assess Pharmacokinetics of Metformin Alone and in Combination With Ranolazine 500 mg
Status: Completed Condition: Type 2 Diabetes Mellitus

Mechanisms of Glucose Lowering Effects of Sitagliptin and Metformin Alone and in Combination in Patients With T2DM
Status: Completed Condition: Diabetes

Metformin Hydrochloride in Patients With Atypical Hyperplasia or In Situ Breast Cancer to Placebo in Decreasing Atypical Cells in Patients With Atypical Hyperplasia or in Situ Breast Cancer
Status: Recruiting Condition: Atypical Ductal Breast Hyperplasia; BRCA1 Mutation Carrier; BRCA2 Mutation Carrier; Ductal Breast Carcinoma in Situ; Lobular Breast Carcinoma in Situ

Dose-finding Study of Metformin With Chemoradiation in Locally Advanced Head and Neck Squamous Cell Carcinoma
Status: Recruiting Condition: Head and Neck Cancer

Effect of Metformin on Biomarkers of Colorectal Tumor Cell Growth
Status: Terminated Condition: Colorectal Neoplasms

Metformin Extended Release Versus Metformin Immediate Release in Subjects With Type 2 Diabetes (CONSENT)
Status: Recruiting Condition: Diabetes Mellitus, Type 2

Chemotherapy and Radiation Therapy With or Without Metformin Hydrochloride in Treating Patients With Stage III Non-small Cell Lung Cancer
Status: Recruiting Condition: Adenosquamous Lung Carcinoma; Bronchioloalveolar Carcinoma; Large Cell Lung Carcinoma; Lung Adenocarcinoma; Recurrent Non-Small Cell Lung Carcinoma; Squamous Cell Lung Carcinoma; Stage IIIA Non-Small Cell Lung Cancer; Stage IIIB Non-Small Cell Lung Cancer

Bioequivalence Study of Saxagliptin and Glucophage Combination Formulations in Healthy Subjects (B)
Status: Completed Condition: Type 2 Diabetes Mellitus

Metformin in Stage IV Lung Adenocarcinoma
Status: Recruiting Condition: Non-small Cell Lung Cancer

Enzalutamide and Metformin Hydrochloride in Treating Patients With Hormone-Resistant Prostate Cancer
Status: Not yet recruiting Condition: Prostate Cancer

The Drug-drug Interaction of SHR3824 and Metformin
Status: Completed Condition: Type 2 Diabetes

Metformin for the Treatment of Nonalcoholic Fatty Liver Disease (NAFLD)
Status: Terminated Condition: Fatty Liver

PK Study Comparing Metformin Eicosapentaenoate to a Combined Dose of Metformin Hydrochloride and Ethyl Ester EPA
Status: Recruiting Condition: Diabetes Mellitus, Non-Insulin-Dependent; Hypertriglyceridemia

Targeting Pathways in Polycystic Ovary Syndrome (PCOS) Using Metformin (MET)
Status: Recruiting Condition: Polycystic Ovary Syndrome

Safety and Efficacy of Co-Administration of Sitagliptin and Metformin in China (MK-0431-121)
Status: Completed Condition: Type 2 Diabetes Mellitus

Paclitaxel and Carboplatin With or Without Metformin Hydrochloride in Treating Patients With Stage III, IV, or Recurrent Endometrial Cancer
Status: Recruiting Condition: Endometrial Adenocarcinoma; Endometrial Clear Cell Adenocarcinoma; Endometrial Serous Adenocarcinoma; Recurrent Uterine Corpus Carcinoma; Stage IIIA Uterine Corpus Cancer; Stage IIIB Uterine Corpus Cancer; Stage IIIC Uterine Corpus Cancer; Stage IVA Uterine Corpus Cancer; Stage IVB Uterine Corpus Cancer

5 mg Glipizide/500 mg Metformin Hydrochloride Tablets, Fasting
Status: Completed Condition: Healthy

Phase II Study of Metformin for Reduction of Obesity-Associated Breast Cancer Risk
Status: Recruiting Condition: Breast Cancer Prevention

Efficacy Study of Pioglitazone and Metformin and Association Between Pioglitazone Response and Peroxisome Proliferator-activated Receptor Gamma Gene Variants in Bangladeshi Type 2 Diabetes Mellitus Subjects
Status: Completed Condition: Type 2 Diabetes Mellitus

5 mg Glipizide/500 mg Metformin Hydrochloride Tablets, Non-Fasting
Status: Completed Condition: Healthy

Bioequivalence Study of Fixed-dose Combinations and Coadministered Individual Tablets of Saxagliptin/Metformin-Brazil
Status: Completed Condition: Type 2 Diabetes Mellitus

PCOS Treatment Using DLBS3233, Metformin, and Combination of Both
Status: Recruiting Condition: Polycystic Ovary Syndrome (PCOS); Insulin Resistance

Polycystic Ovary Syndrome and Liraglutide as Add-on Therapy on Metformin
Status: Completed Condition: PCOS; Obesity

Bioequivalence of a Medium, Fixed Dose Combination Tablet of Linagliptin/Metformin Extended Release in Healthy Subjects.
Status: Completed Condition: Healthy

Metformin for the Treatment of Unexplained Hypospermatogenesis
Status: Recruiting Condition: Infertility

Bioequivalence Study of Saxagliptin and Glucophage Combination Formulations in Healthy Subjects (A)
Status: Completed Condition: Type 2 Diabetes Mellitus

Exercise and Metformin in Colorectal and Breast Cancer Survivors
Status: Recruiting Condition: Colorectal Cancer; Breast Cancer

Metformin and Sitagliptin Therapy for Adult Patients With Type 2 Diabetes Admitted to the General Medical Unit
Status: Not yet recruiting Condition: Type 2 Diabetes Mellitus

Effectiveness of Metformin in Recurrent Miscarriage in a Woman With Hyperinsulinaemia
Status: Recruiting Condition: Abortion, Habitual

Metformin in Amnestic Mild Cognitive Impairment
Status: Completed Condition: Amnestic Mild Cognitive Impairment

Neoadjuvant Letrozole Plus Metformin vs Letrozole Plus Placebo for ER-positive Postmenopausal Breast Cancer
Status: Recruiting Condition: Hormone Receptor Positive Malignant Neoplasm of Breast

Metformin in Obese Children and Adolescents
Status: Recruiting Condition: Obesity; Insulin Resistance

The Metformin Active Surveillance Trial (MAST) Study
Status: Recruiting Condition: Prostate Cancer

A Study of the Effects of Co-Administration of Sitagliptin (MK-0431) and Metformin on Incretin Hormone Concentrations (MK-0431-110)
Status: Completed Condition: Type 2 Diabetes Mellitus

Metformin Hydrochloride and Combination Chemotherapy in Treating Patients With Stage III-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Status: Recruiting Condition: Brenner Tumor; Malignant Ascites; Malignant Pleural Effusion; Ovarian Clear Cell Cystadenocarcinoma; Ovarian Endometrioid Adenocarcinoma; Ovarian Mixed Epithelial Carcinoma; Ovarian Serous Cystadenocarcinoma; Ovarian Undifferentiated Adenocarcinoma; Recurrent Fallopian Tube Cancer; Recurrent Ovarian Epithelial Cancer; Recurrent Ovarian Germ Cell Tumor; Recurrent Primary Peritoneal Cavity Cancer; Stage IIIA Fallopian Tube Cancer; Stage IIIA Ovarian Epithelial Cancer; Stage IIIA Ovarian Germ Cell Tumor; Stage IIIA Primary Peritoneal Cavity Cancer; Stage IIIB Fallopian Tube Cancer; Stage IIIB Ovarian Epithelial Cancer; Stage IIIB Ovarian Germ Cell Tumor; Stage IIIB Primary Peritoneal Cavity Cancer; Stage IIIC Fallopian Tube Cancer; Stage IIIC Ovarian Epithelial Cancer; Stage IIIC Ovarian Germ Cell Tumor; Stage IIIC Primary Peritoneal Cavity Cancer; Stage IV Fallopian Tube Cancer; Stage IV Ovarian Epithelial Cancer; Stage IV Ovarian Germ Cell Tumor; Stage IV Primary Peritoneal Cavity Cancer

Pharmacokinetics of Fixed Dose Combination (FDC) Tablets of Linagliptin /Metformin
Status: Completed Condition: Healthy

Advanced Lung Cancer Treatment With Metformin and Chemo-Radiotherapy
Status: Recruiting Condition: Lung Cancer

A Relative Bioavailability Study of Metformin HCl 750 mg ER Tablets Under Fasting Conditions
Status: Completed Condition: Healthy

A Relative Bioavailability Study of Metformin HCl 750 mg ER Tablets Under Non-fasting Conditions
Status: Completed Condition: Healthy

Effect Of CP-690,550 On The Pharmacokinetics Of Metformin In Healthy Volunteers
Status: Completed Condition: Rheumatoid Arthritis

Metformin Glycinate on Metabolic Control and Inflammatory Mediators in Type 2 Diabetes
Status: Active, not recruiting Condition: Type 2 Diabetes

Linagliptin in Combination With Metformin in Treatment Naive Patients With Type 2 Diabetes Mellitus and Insufficient Glycaemic Control
Status: Completed Condition: Diabetes Mellitus, Type 2

Bioequivalence Study of 500 mg and 1000 mg Glucophage (Metformin) Tablets in Healthy Subjects
Status: Completed Condition: Type 2 Diabetes Mellitus

Efficacy Study of Metformin Glycinate on Postprandial Lipemia
Status: Not yet recruiting Condition: Type 2 Diabetes

Bioequivalence Study of the Fixed Dose Combination of 5 mg Saxagliptin/1000 mg Metformin XR (Manufactured in Mt Vernon, IN) Relative to 5 mg of Onglyza and 2 × 500 mg Glucophage XR
Status: Completed Condition: Diabetes Mellitus

Metformin for the Prevention of the Metabolic Side-effects of Zyprexa
Status: Completed Condition: Metabolic Complications

Effect of Metformin on Breast Cancer Metabolism
Status: Completed Condition: Breast Cancer

Drug-drug Interaction Study With Metformin and Imatinib
Status: Completed Condition: Healthy

Efficacy and Safety of Alogliptin and Metformin Fixed-dose Combination in Patients With Type 2 Diabetes
Status: Active, not recruiting Condition: Diabetes Mellitus

Bioequivalence of a Low, Fixed Dose Combination Tablet of Linagliptin/Metformin Extended Release in Healthy Subjects
Status: Completed Condition: Healthy

Lapatinib With Sirolimus or Metformin
Status: Active, not recruiting Condition: Advanced Cancers

Metformin for Reduction of Paclitaxel-Related Neuropathy in Patients With Breast Cancer
Status: Not yet recruiting Condition: Breast Cancer

Metformin Hydrochloride, Carboplatin, and Paclitaxel in Treating Patients With Recurrent Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Status: Withdrawn Condition: Ovarian Papillary Serous Carcinoma; Ovarian Serous Cystadenocarcinoma; Recurrent Fallopian Tube Cancer; Recurrent Ovarian Epithelial Cancer; Recurrent Ovarian Germ Cell Tumor; Recurrent Primary Peritoneal Cavity Cancer

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
Glenmark Generics
METFORMIN HYDROCHLORIDE
metformin hydrochloride
TABLET;ORAL078170-003May 23, 2008RXNo<disabled><disabled>
Mylan Pharms Inc
METFORMIN HYDROCHLORIDE
metformin hydrochloride
TABLET;ORAL075969-003Jan 29, 2002RXNo<disabled><disabled>
Zydus Pharms Usa
METFORMIN HYDROCHLORIDE
metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL077060-001Apr 20, 2005RXNo<disabled><disabled>
Sandoz
METFORMIN HYDROCHLORIDE
metformin hydrochloride
TABLET, EXTENDED RELEASE;ORAL076223-001Dec 14, 2004DISCNNo<disabled><disabled>
Ivax Sub Teva Pharms
METFORMIN HYDROCHLORIDE
metformin hydrochloride
TABLET;ORAL075975-004Jan 24, 2002DISCNNo<disabled><disabled>
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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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