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Details for Generic Name: loperamide hydrochloride

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Loperamide hydrochloride is the generic ingredient in six branded drugs marketed by J And J Consumer Inc, Banner Life Sciences, Mylan, Roxane, Sandoz, Teva, Janssen Pharms, Alpharma Us Pharms, Duramed Pharms Barr, Hi Tech Pharma, Perrigo, Watson Labs, Wockhardt, Perrigo R And D, Able, Aurobindo Pharma Ltd, Contract Pharmacal, LNK, Ohm Labs, and Sun Pharm Inds Ltd, and is included in thirty-two NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are ten drug master file entries for loperamide hydrochloride. Twenty-one suppliers are listed for this compound.

Summary for Generic Name: loperamide hydrochloride

Drug Master File Entries: see list10
Suppliers / Packaging: see list33
Therapeutic Class:Gastrointestinal Agents

Clinical Trials for: loperamide hydrochloride

Efficacy and Safety Study of Loperamide Hydrochloride/Simethicone Chewable Tablet in Treatment of Acute Diarrhea With Abdominal Discomfort and Flatulence
Status: Completed Condition: Diarrhea

Efficacy of Loperamide in Treating Patients for C. Difficile Colitis and Diarrheal Disease of Unknown Cause Associated With Antibiotic Therapy
Status: Recruiting Condition: Antibiotic Associated Diarrhea; Clostridium Difficile

Controlling Anal Incontinence by Performing Anal Exercises With Biofeedback or Loperamide (CAPABLe)
Status: Active, not recruiting Condition: Fecal Incontinence

Azithromycin, With or Without Loperamide, to Treat Travelers' Diarrhea
Status: Completed Condition: Diarrhea

Loperamide Grapefruit Juice Interaction PK Trial
Status: Completed Condition: Drug Interaction

Loperamide vs. Placebo's Effect on Ileostomy Output: A Clinical Randomized Blinded Cross-over Study
Status: Recruiting Condition: Rectal Cancer; Ulcerative Colitis; Short Bowel Syndrome

Effects of Methylnaltrexone in Comparison to Naloxone on Loperamide-induced Delay of the Oro-cecal, Whole-gut and Colon Transit Time.
Status: Completed Condition: Intestinal Obstruction

Use of Post Operative Loperamide in Colorectal Patients After Diverting Ileostomies
Status: Recruiting Condition: Dehydration, Diverting Ileostomy, Loperamide

A Comparison of Three Medications to Treat Diarrhea in Adults.
Status: Completed Condition: Diarrhea

Bioequivalence Study of Loperamide Hydrochloride 2 mg and Simethicone 125 mg Tablet Under Fasting Conditions
Status: Completed Condition: Healthy

Imodium Syrup Versus Imodium Tablets for Faecal Incontinence
Status: Withdrawn Condition: Fecal Incontinence

Effects of 500 mg Immediate Release and Extended Release Methylnaltrexone on Loperamide-induced Delay of the Oro-cecal and Whole-gut Transit Time in Healthy Subjects
Status: Completed Condition: Intestinal Obstruction

Octreotide Compared With Loperamide Hydrochloride for Chemotherapy-Related Diarrhea in Patients With Colorectal Cancer
Status: Completed Condition: Colorectal Cancer; Diarrhea

Rifaximin, Loperamide and the Combination to Treat Travelers' Diarrhea
Status: Completed Condition: Travelers' Diarrhea

A Study Looking the Incidence and Severity of Diarrhea in Patients With Early-Stage HER2+ Breast Cancer Treated With Neratinib and Loperamide
Status: Recruiting Condition: Early Stage HER2+ Breast Cancer

Efavirenz and Ritonavir on Human Brian P-Glycoprotein
Status: Active, not recruiting Condition: Drug Effects

Pilot Study to Assess Dimethyl Fumarate Related GI Symptom Mitigation
Status: Terminated Condition: Relapsing Remitting Multiple Sclerosis

Study to Determine the Best Way to Measure How Quickly the Drug Can Give Relief From Sudden Diarrhea
Status: Completed Condition: Diarrhea

The Pharmacodynamic/Pharmacokinetic Interaction of Tipranavir and Ritonavir With Loperamide in Healthy Volunteers
Status: Completed Condition: Healthy

Combination Therapy With Biofeedback, Loperamide and Stool Bulking Agents
Status: Completed Condition: Fecal Incontinence

Acupuncture for Patients With Diarrhea-predominant IBS or Functional Diarrhea: a Randomized Controlled Trial
Status: Completed Condition: Diarrhea-predominant Irritable Bowel Syndrome; Functional Diarrhea

Evaluation of the Efficacy of Low-dose Acetylsalicylic Acid on Diarrhea Induced by Anti-cancer Targeted Therapies.
Status: Withdrawn Condition: Cancer

The Use of a Non-absorbable Marker for the Evaluation of the Gastrointestinal Transit
Status: Recruiting Condition: Concentration-Time Profiles in Stomach & Intestine.

Evaluation of Lanreotide Efficacity in High Output Stoma: a Multicentric Randomized Study
Status: Recruiting Condition: High Output Stoma

Trial Evaluating Ambulatory Treatment of Travelers' Diarrhea
Status: Recruiting Condition: Acute Watery Diarrhea; Dysentery/Febrile Diarrhea

Calcium Aluminosilicate Anti-Diarrheal in Treating and Preventing Diarrhea in Patients With Metastatic Colorectal Cancer Receiving Irinotecan
Status: Completed Condition: Chemotherapeutic Agent Toxicity; Colorectal Cancer; Diarrhea

A Study to Determine Effective Prophylaxis and Treatment of Nelfinavir-Associated Diarrhea
Status: Terminated Condition: Diarrhea

Educational-Medical-Behavioral Treatment of Fecal Incontinence
Status: Enrolling by invitation Condition: Fecal Incontinence

Duration of P-glycoprotein Inhibition After Oral Administration of HM30181AK Tablet
Status: Completed Condition: Healthy

A Phase III Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Investigational Product MP-101 in Subjects With Short Bowel Syndrome Who Have Had an Inadequate Response to Anti-Diarrheals
Status: Withdrawn Condition: Short Bowel Syndrome; Short Gut Syndrome; SBS; Short Bowel; Short Gut

Prospective Randomized Open Label Study of the Treatment of Therapy-Associated Diarrhea During Percutaneous Radiation Therapy of the Small Pelvis. - Comparison of Loperamide and Tincture of Opium -
Status: Not yet recruiting Condition: Diarrhea; Enteritis; Cancer

Proof-of-Concept, Calcium Aluminosilicate Anti-Diarrheal (CASAD) for Treatment of Clostridium Difficile Infection
Status: Terminated Condition: Diarrhoea, Clostridium Difficile

Efficacy and Mechanisms of Pharmacologic Treatment of Fecal Incontinence
Status: Completed Condition: Fecal Incontinence

ADAM-Afatinib Diarrhea Assessment and Management
Status: Completed Condition: Carcinoma, Non-Small-Cell Lung

Novel Topical Therapies for the Treatment of Genital Pain
Status: Enrolling by invitation Condition: Female Genital Diseases

A Neoadjuvant Study of Abemaciclib (LY2835219) in Postmenopausal Women With Hormone Receptor Positive, HER2 Negative Breast Cancer
Status: Recruiting Condition: Breast Cancer; Hormone Receptor Positive Tumor; Early-Stage Breast Carcinoma

CASAD for Severe Diarrhea in the Emergency Department
Status: Terminated Condition: Cancer; Diarrhea

Xia Shi Surgical Treatment for Eczema Multi-center Clinical Research
Status: Not yet recruiting Condition: Eczema

(11C)dLop as a Marker of P-Glycoprotein Function in Patients With Gliomas
Status: Terminated Condition: Low Grade Glioma; Glioblastoma Multiforme; Anaplastic Astrocytoma; Anaplastic Oligodendroglioma; Oligoastrocytoma

The Efficacy of CASAD in Patients With Diarrhea Related to Medullary Thyroid Cancer
Status: Recruiting Condition: Diarrhea; Medullary Thyroid Cancer

DHB Supplement Interaction Study
Status: Recruiting Condition: Healthy Volunteers

Bioequivalence Between a Racecadotril Capsule and Film-Coated Tablet (FCT) to Treat Diarrhea in Adults
Status: Completed Condition: Antidiarrheals

A Open Label Extension Study for Subjects That Complete Study MP-101-CL-001
Status: Withdrawn Condition: Short Bowel Syndrome; Short Gut Syndrome; SBS; Short Gut

Impact of Training on Diarrhoea Management
Status: Completed Condition: Acute Childhood Diarrhea

Study to Compare the Pharmacokinetics Profiles of Four Racecadotril Products
Status: Completed Condition: Diarrhea

Stopping Antihypertensive Treatment amOng Hypertensive Patients in Primary Care (STOP-Trial)
Status: Not yet recruiting Condition: Hypertension

Cardiac ARrest : Brain OXymetry Depending on HYpothermia Depth
Status: Recruiting Condition: Cardiac Arrest

Erlotinib in Treating Patients With Recurrent Glioblastoma Multiforme or Gliosarcoma
Status: Terminated Condition: Adult Brain Tumors

Clinical Study to Assess Efficacy and Safety of Amiodarone in Treating Patients With Ebola. Virus Disease (EVD) in Sierra Leone. EASE (EMERGENCY Amiodarone Study Against Ebola)
Status: Withdrawn Condition: Ebola Virus Disease

Safety, Efficacy and Cost-effectiveness of Racecadotril in Children With Acute Diarrhea in Mexico
Status: Completed Condition: Diarrhea

Pectin Start Early Enteral Nutritional Support in Critically Ill Patients
Status: Completed Condition: Nutrition Disorders; Critical Illness

Azithromycin in the Treatment of Cryptosporidiosis in Patients Who Have Not Had Success With Other Drugs
Status: Completed Condition: Cryptosporidiosis; HIV Infections

A Randomized, Multicenter, Double-Blind, Parallel-Group, Placebo-Controlled Trial of the Efficacy and Safety of Bovine Anti-Cryptosporidium Immunoglobulin (BACI) in the Treatment of Cryptosporidium Enteritis in AIDS Patients
Status: Completed Condition: Cryptosporidiosis; HIV Infections

Diethylhomospermine (DEHSPM) for Refractory AIDS-Related Diarrhea
Status: Completed Condition: Diarrhea; HIV Infections

Study of Prophylactic Octreotide to Prevent or Reduce the Frequency and Severity of Diarrhoea in Subjects Receiving Lapatinib With Capecitabine for the Treatment of Metastatic Breast Cancer
Status: Not yet recruiting Condition: Cancer

A Study to Evaluate Topical Phenylephrine Gel in the Management of Faecal Incontinence
Status: Withdrawn Condition: Faecal Incontinence

Probiotic Supplementation in Preventing Treatment-Related Diarrhea in Patients With Cancer Undergoing Chemotherapy
Status: Withdrawn Condition: Diarrhea; Unspecified Adult Solid Tumor, Protocol Specific

Efficacy of Gelatin Tannate in Treatment Acute Gastroenteritis in Children.
Status: Recruiting Condition: Acute Gastroenteritis

Probiotic LGG for Prevention of Side Effects in Patients Undergoing Chemoradiation for Gastrointestinal Cancer
Status: Recruiting Condition: Gastrointestinal Neoplasms

A Phase II Neo-adjuvant Study Assessing TCH (Docetaxel, Carboplatin and Trastuzumab) and TCHL (Docetaxel, Carboplatin, Trastuzumab and Lapatinib) in HER-2 Positive Breast Cancer Patients.
Status: Active, not recruiting Condition: Breast Cancer

Lapatinib or Trastuzumab Given Prior to Surgery With Chemotherapy in Patients With Early Breast Cancer
Status: Withdrawn Condition: Neoplasms, Breast

A Study of Colesevelam in Fecal Incontinence
Status: Recruiting Condition: Fecal Incontinence; Bile Acid Malabsorption

Study of Glutamine as Prophylaxis for Irinotecan Induced Diarrhea
Status: Completed Condition: Metastatic Colorectal Cancer

Economics of Diarrhoea in Intensive Care Unit
Status: Completed Condition: Critical Illness

Zinc Supplementation to Reduce Diarrhea Rates in Adults in Western Kenya.
Status: Completed Condition: Diarrhea; Malaria

For Prevention of Diarrhea in Patients Diagnosed With Metastatic Colorectal Cancer Treated With Chemotherapy
Status: Terminated Condition: Neoplasm Metastasis; Colorectal Neoplasms

Diarrhea Predominant Irritable Bowel Syndrome in Females
Status: Completed Condition: Irritable Bowel Syndrome

Sulfasalazine in Preventing Acute Diarrhea in Patients With Cancer Who Are Undergoing Pelvic Radiation Therapy
Status: Active, not recruiting Condition: Diarrhea; Gastrointestinal Complications; Unspecified Adult Solid Tumor, Protocol Specific

A Study of Xiang-Sha-Liu-Jun-Zi-Tang in Patients With Irritable Bowel Syndrome
Status: Recruiting Condition: Irritable Bowel Syndrome

Safety and Efficacy of AST-120 in the Treatment of Pouchitis
Status: Completed Condition: Pouchitis

Impact of Probiotics BIFILACT® on Diarrhea in Patients Treated With Pelvic Radiation
Status: Completed Condition: Cancer; Diarrhea; Abdominal Pain; Quality of Life

A Multicenter Study to Assess the Tolerability of Once Daily Lopinavir/Ritonavir (LPV/r) Liquid Versus Capsules
Status: Completed Condition: HIV Infection

Safety and Efficacy of AST-120 in the Treatment of Antibiotic-Refractory Pouchitis
Status: Terminated Condition: Pouchitis

PS-341 and Radiation to Treat Advanced Cancer of the Head and Neck
Status: Completed Condition: Squamous Cell Carcinoma

Alvocidib, Oxaliplatin, Fluorouracil, and Leucovorin Calcium in Treating Patients With Advanced Solid Tumors
Status: Completed Condition: Unspecified Adult Solid Tumor, Protocol Specific

Triple Target Treatment (3T) Which Combines Stimulation With Amplitude Modulated Middle Frequency (AM-MF), Electromyography (EMG)-Triggered Stimulation and EMG-Biofeedback Compared With EMG-Biofeedback in Anal Incontinence
Status: Completed Condition: Fecal Incontinence

Patient Attributes for Optimal Treatment Outcome in Irritable Bowel Syndrome.
Status: Not yet recruiting Condition: Irritable Bowel Syndrome

The Effect of Physiotherapy for the Treatment of Fecal Incontinence.
Status: Recruiting Condition: Fecal Incontinence

Efficacy of Favipiravir Against Severe Ebola Virus Disease
Status: Completed Condition: Ebola Virus Disease

Observational Study of Perioperative Chemotherapy in Gastric Cancer
Status: Active, not recruiting Condition: Gastric Cancer

Intra-corporeal vs Extra-corporeal Anastomosis in Laparoscopically Assisted Right Hemicolectomy
Status: Recruiting Condition: Pain

ISOperistaltic Versus ANTIperistaltic Anastomosis After Laparoscopic Right Colectomy for Cancer
Status: Recruiting Condition: Primary Malignant Neoplasm of Ascending Colon

Anti-peristaltic Ileo-sigmoid Anastomosis for the Treatment of Slow-transit Constipation:Therapeutic Evaluation
Status: Completed Condition: Constipation

Antibiotic Therapy and Antacids in Patients With Malt Lymphoma of the Stomach
Status: Completed Condition: Lymphoma

Sugammadex Versus Neostigmine for Postoperative Nausea and Vomiting After Laparoscopic Gynaecological Surgery
Status: Recruiting Condition: Postoperative Nausea and Vomiting

Comparing Opium Tincture (OT) With Methadone for Substitution Treatment of Opioid Dependence
Status: Not yet recruiting Condition: Opioid Dependence

Pectin, Aging and Intestinal Barrier Function
Status: Recruiting Condition: Healthy Young Adults; Healthy Elderly

Evaluating the Synergism of Soluble Dietary Fiber With Fecal Microbiota Transplantation in Chronic Constipation
Status: Recruiting Condition: Chronic Constipation

Effects of Pectin Supplementation in Diarrhea-predominant Irritable Bowel Syndrome
Status: Completed Condition: Irritable Bowel Syndrome

Effect of Soluble Dietary Fiber on Bacterial Translocation in Crohn's Disease
Status: Recruiting Condition: Crohn's Disease

Use of Novel Prebiotic Fiber for Targeted Dietary Management of Irritable Bowel Syndrome (Nutrabiotix Phase II)
Status: Recruiting Condition: Constipation-predominant IBS (IBS-C)

MRI and Microbiota Analysis in Constipation
Status: Active, not recruiting Condition: Constipation

Psyllium Fiber Versus Placebo in Early Treatment After STARR for Obstructed Defecation: a Double-blind RCT
Status: Completed Condition: Constipation; Incontinence

Intranasal Transmucosal Fentanyl Pectin for Breakthrough Cancer Pain in Radiation-induced Oropharyngeal Mucositis
Status: Completed Condition: Breakthrough Pain; Mucositis; Radiotherapy; Chemotherapy; Head and Neck Cancer

Impact of Bismuth Subsalicylate on Antimicrobial Use Among Adult Diarrhea Outpatients--Pakistan
Status: Completed Condition: Diarrhea

Effects of Pectin on Flora Intestinal Colonization and Maintenance After Fecal Transplantation
Status: Recruiting Condition: Inflammatory Bowel Disease

REVIVE: Replens Versus Intra-Vaginal Estrogen for the Treatment of Vaginal Dryness on Aromatase Inhibitor Therapy
Status: Recruiting Condition: Estrogen Receptor Positive Breast Cancer; Breast Cancer

PEctin Rapid Fentanyl Efficacy Clinical Trial For pAin at Swallowing Undergoing radioTherapy
Status: Withdrawn Condition: Predictable BTP at Swallowing in in Head/Neck Cancer Patients Undergoing Radiotherapy Already Receiving Opioid Therapy for Background Pain

CANHelp Working Group Treatment Trials
Status: Enrolling by invitation Condition: Helicobacter Pylori Infection

Galectin-3 Blockade in Patients With High Blood Pressure
Status: Recruiting Condition: Hypertension

Courtesy of
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
Hi Tech Pharma
loperamide hydrochloride
SOLUTION;ORAL074352-001Nov 17, 1995OTCNo<disabled><disabled>
loperamide hydrochloride
CAPSULE;ORAL073192-001Apr 30, 1992RXNo<disabled><disabled>
Ohm Labs
loperamide hydrochloride
TABLET;ORAL074091-001Dec 10, 1992OTCNo<disabled><disabled>
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Expired Orange Book Patents for Generic Ingredient: loperamide hydrochloride

These historical archives are available as an add-on to one-year subscriptions

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
J And J Consumer Inc
loperamide hydrochloride
CAPSULE;ORAL017694-001Approved Prior to Jan 1, 19823,714,159<disabled>
Janssen Pharms
loperamide hydrochloride
SOLUTION;ORAL019037-001Jul 31, 19843,714,159<disabled>
J And J Consumer Inc
loperamide hydrochloride
SOLUTION;ORAL019487-001Mar 1, 19883,714,159<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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