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Details for Generic Name: lansoprazole

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Lansoprazole is the generic ingredient in seven branded drugs marketed by Dr Reddys Labs Ltd, Mylan Pharms Inc, Natco Pharma Ltd, Perrigo R And D, Sandoz, Sun Pharma Global, Teva Pharms, Wockhardt Ltd, Wockhardt Usa, Zydus Hlthcare, Krka Tovarna Zdravil, Takeda Pharms Usa, Novartis, Takeda Pharms Na, and Ani Pharms Inc, and is included in twenty NDAs. There are five patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

There are fourty-nine drug master file entries for lansoprazole. Nine suppliers are listed for this compound.

Summary for Generic Name: lansoprazole

Tradenames:7
Patents:5
Applicants:15
NDAs:20
Drug Master File Entries: see list49
Suppliers: see list9
Therapeutic Class:Gastrointestinal Agents

Pharmacology for Ingredient: lansoprazole

Drug ClassProton Pump Inhibitor
Mechanism of ActionProton Pump Inhibitors

Clinical Trials for: lansoprazole

Intravenous vs Oral Lansoprazole on Gastric Acid Secretion in Subjects With Erosive Esophagitis
Status: Completed Condition: Esophagitis; Reflux

Efficacy/Safety of Lansoprazole in Patients With Frequent Nighttime Heartburn
Status: Completed Condition: Frequent Heartburn

Safety and Efficacy of Dexlansoprazole Delayed-Release Capsules in Treating Symptomatic Non-Erosive Gastroesophageal Reflux Disease in Adolescents
Status: Completed Condition: Gastroesophageal Reflux Disease

Lansoprazole for Subgroups of Functional Dyspepsia
Status: Terminated Condition: Functional Dyspepsia

Bioavailability, Safety, and Pharmacodynamics of Dexlansoprazole Delayed-Release Orally Disintegrating Tablets in Healthy Participants
Status: Completed Condition: Bioavailability

Efficacy and Safety of Dexlansoprazole MR and Lansoprazole on Healing of Erosive Esophagitis
Status: Completed Condition: Esophagitis, Reflux; Esophagitis, Peptic

Efficacy and Safety of Dexlansoprazole MR and Lansoprazole on Healing of Erosive Esophagitis
Status: Completed Condition: Esophagitis, Reflux; Esophagitis, Peptic

Dexilant Treatment in Gastrointestinal Reflux Disease (GERD Related Non Cardiac Chest Pain
Status: Withdrawn Condition: Chest Pain; Gastrointestinal Reflux Disease

Effect of Prevacid on Prostaglandin Levels in Patient With Stress Ulcer
Status: Completed Condition: Stomach Ulcer

Lansoprazole Intravenous 30 mg Specified Drug-use Survey [Hemostatic Effect/Rebleeding Rate]
Status: Completed Condition: Gastric Ulcer, Duodenal Ulcer, Acute Stress Gastritis, and Acute Gastric Mucosal Lesions

Takepron Intravenous 30 mg Specified Drug-use Survey [Acute Stress Ulcer and Acute Gastric Mucosal Lesions]
Status: Completed Condition: Acute Stress Ulcer and Acute Gastric Mucosal Lesions

A Study of the Effects of Multiple Doses of Dexlansoprazole, Lansoprazole, Omeprazole or Esomeprazole on the Pharmacokinetics and Pharmacodynamics of Clopidogrel in Healthy Participants.
Status: Completed Condition: Healthy

Safety and Efficacy of Lansoprazole in Patients With Reflux Disease
Status: Completed Condition: Gastroesophageal Reflux

Safety and Efficacy of Dexlansoprazole Delayed-Release Capsules for Healing of Erosive Esophagitis and Maintenance of Healed Erosive Esophagitis and Relief of Heartburn in Adolescents
Status: Recruiting Condition: Gastroesophageal Reflux Disease; Erosive Esophagitis

Multicenter, Randomized, Double-Blind, Double-Dummy, Parallel-Group Comparison of the Remission Rates of Once Daily Treatment With Esomeprazole 20mg and Lansoprazole 15mg for 6 Months in Patients Whose EE Has Been Healed
Status: Completed Condition: Erosive Esophagitis

The Insulin Independence Trial (IIT) Evaluating the Safety and Efficacy of Oral Cyclosporine and Oral Lansoprazole for Insulin Independence Among Patients With Existing Type 1 Diabetes
Status: Not yet recruiting Condition: Type 1 Diabetes

Long-term Use of Takepron Capsules on the Prevention of Recurrence of Gastric/Duodenal Ulcer in Patients Receiving Low-dose Aspirin
Status: Completed Condition: Gastric or Duodenal Ulcers

Long-term Use of Takepron on the Prevention of Recurrence of Gastric/Duodenal Ulcer in Patients Receiving Non-steroidal Anti-inflammatory Drugs
Status: Completed Condition: Gastric or Duodenal Ulcers

A Safety and Efficacy Study of Lansoprazole in Preventing Aspirin-Induced Gastric and Duodenal Ulcers
Status: Terminated Condition: Stomach Ulcer; Duodenal Ulcer

Study to Evaluate the Pharmacokinetics and Safety of Dexlansoprazole in Pediatric Subjects With Symptomatic Gastroesophageal Reflux Disease
Status: Completed Condition: Gastroesophageal Reflux

Lansoprazole in Preterm Infants With Reflux
Status: Completed Condition: Preterm Infants; Gastrointestinal Reflux

Bioequivalence Study of Lansoprazole DR Capsules 30 mg in Fasting Conditions
Status: Completed Condition: Healthy

Lansoprazole Tablets Special Drug Use Surveillance Gastroesophageal Reflux Disease With Dyspepsia Symptoms
Status: Completed Condition: Gastroesophageal Reflux Disease With Dyspepsia Symptoms

Comparison of Dexlansoprazole MR to Placebo on the Ability to Maintain Healing in Subjects With Healed Erosive Esophagitis
Status: Completed Condition: Esophagitis, Reflux; Esophagitis, Peptic

A Study to Evaluate the Effect of Lansoprazole on Infants With Gastroesophageal Reflux Disease.
Status: Completed Condition: Gastroesophageal Reflux Disease

Efficacy and Safety of Dexlansoprazole MR on Maintaining Healing in Subjects With Healed Erosive Esophagitis
Status: Completed Condition: Esophagitis, Reflux; Esophagitis, Peptic

A Study to Evaluate the Effect of Lansoprazole on Hospitalized Neonates With Gastroesophageal Reflux Disease
Status: Completed Condition: Gastroesophageal Reflux Disease

Safety and Efficacy of Dexlansoprazole Modified Release Formulation to Treat Heartburn
Status: Completed Condition: Gastroesophageal Reflux Disease

Efficacy and Safety of Dexlansoprazole Modified Release Formulation to Treat Heartburn
Status: Completed Condition: Gastroesophageal Reflux Disease

Safety and Quality of Life Study of Dexlansoprazole Modified Release Formulation to Treat Heartburn
Status: Completed Condition: Gastroesophageal Reflux Disease

Efficacy/Safety of Lansoprazole in Patients With Frequent Heartburn
Status: Completed Condition: Heartburn

Study Comparing Esomeprazole Magnesium 40mg Once Daily Versus Lansoprazole 30 mg Twice Daily in Symptom Control of Subjects With Persistent Gastrooesophageal Reflux Disease (GERD)
Status: Completed Condition: Heartburn; Gastroesophageal Reflux Disease

Safety and Efficacy of Dexlansoprazole Modified Release Formulation to Treat Gastroesophageal Reflux Disease
Status: Completed Condition: Gastroesophageal Reflux Disease

Efficacy and Safety of Dexlansoprazole MR Compared to Placebo on Maintaining Healing in Subjects With Healed Erosive Esophagitis
Status: Completed Condition: Esophagitis, Reflux; Esophagitis, Peptic

Pharmacokinetic and Safety of Dexlansoprazole in Adolescents With Gastroesophageal Reflux Disease
Status: Completed Condition: Gastroesophageal Reflux

An Efficacy Study to Compare the Treatment Effects of Rabeprazole and Lansoprazole Depending on the Genotyping of CYP2C19 in Treating Reflux Esophagitis
Status: Completed Condition: Reflux Esophagitis

Effect of Dexlansoprazole 60 mg QD and 60 mg BID on Recurrence of Intestinal Metaplasia in Subjects Who Have Achieved Complete Eradication of Barrett's Esophagus With Radiofrequency Ablation
Status: Recruiting Condition: Barrett's Esophagus

Efficacy and Safety of Lansoprazole on Gastric and Duodenal Ulcers in Patients Taking Nonsteroidal Anti-Inflammatory Drugs
Status: Completed Condition: Stomach Ulcer; Duodenal Ulcer

A Randomized, Open-Label, Comparative 3-Way Treatment Crossover Study of 24-Hour Intragastric pH Profile of Once Daily Oral Administration of Esomeprazole 40mg, Lansoprazole 30mg, and Pantoprazole 40mg at Steady State in NSAID-Using Patients
Status: Completed Condition: Heartburn; Upper Abdominal Pain; Nausea; Acid Regurgitation

The Insulin Independence Trial (IIT) Evaluating the Safety and Efficacy of Oral Cyclosporine and Oral Lansoprazole for Insulin Independence Among Recent Onset Type 1 Diabetes Patients
Status: Not yet recruiting Condition: Type 1 Diabetes

Efficacy of Dexlansoprazole MR on Heartburn Control in Participants Previously Receiving Twice Daily Proton Pump Inhibitor Therapy
Status: Completed Condition: Gastroesophageal Reflux

The Effect of Lansoprazole in Combination With Ecabet Sodium for Gastroesophageal Reflux Disease
Status: Completed Condition: Gastroesophageal Reflux Disease

Combination Therapy With Sitagliptin and Lansoprazole to Restore Pancreatic Beta Cell Function in Recent-Onset Type 1 Diabetes
Status: Active, not recruiting Condition: Type 1 Diabetes

Effect of Dexlansoprazole on Bone Homeostasis
Status: Active, not recruiting Condition: Homeostasis; Bone and Bones

Lansoprazole 30 mg DR Capsule Fasting Study
Status: Completed Condition: Healthy

Efficacy of TAK-438 Compared to AG-1749 (Lansoprazole) in the Treatment of Erosive Esophagitis
Status: Completed Condition: Erosive Esophagitis

Lansoprazole 30 mg DR Capsule Replicate Food Study
Status: Completed Condition: Healthy

Comparison of the Efficacy for Stress Ulcer Prophylaxis Between the Patients Received Lansoprazole OD and Control Group Weaning From Mechanical Ventilator in Respiratory Care Center: a Randomized Control Trial
Status: Completed Condition: Respiratory Failure

A Multicenter, Randomized, Double Blind, Double Dummy, Parallel-Group Efficacy Study Comparing 8 Weeks of Treatment With Esomeprazole Magnesium (40mg qd) to Lansoprazole (30mg qd) for the Healing of Erosive Esophagitis in Patients With Moderate or Severe Erosive Esophagitis
Status: Completed Condition: Erosive Esophagitis

Lansoprazole 30 mg DR Capsule Fasting Replicate Sprinkle Study
Status: Completed Condition: Healthy

The Use of Lansoprazole to Treat Infants With Symptoms of Gastroesophageal Reflux
Status: Completed Condition: Gastroesophageal Reflux Disease

Sensory Evaluation of Dexlansoprazole Delayed-Release Orally Disintegrating Tablets
Status: Completed Condition: Gastroesophageal Reflux Disease; Erosive Esophagitis; Heartburn

Efficacy of Lansoprazole in Chronic Post Nasal Drip
Status: Completed Condition: Larynx Disease

Efficacy of TAK-438 Compared to AG-1749 (Lansoprazole) in the Treatment of Gastric Ulcer
Status: Completed Condition: Gastric Ulcer

Efficacy and Safety of TAK-438 Compared to AG-1749 (Lansoprazole) in the Treatment of Duodenal Ulcer
Status: Completed Condition: Duodenal Ulcer

The Effects of Dexlansoprazole for the Treatment of Throat-Related Reflux
Status: Terminated Condition: Laryngopharyngeal Reflux

Lansoprazole Versus Mosapride for Functional Dyspepsia
Status: Completed Condition: Functional Dyspepsia; Epigastric Pain Syndrome; Post Prandial Distress Syndrome

Efficacy of TAK-438 Compared to AG-1749 (Lansoprazole) in the Maintenance Treatment of Healed Erosive Esophagitis
Status: Completed Condition: Erosive Esophagitis

Pharmacokinetic Study of Lansoprazole in Cystic Fibrosis
Status: Completed Condition: Cystic Fibrosis

Proof of Concept Study Efficacy of an Antacid/Lansoprazole Combination for Relief of Heartburn
Status: Completed Condition: Heartburn

Study Evaluating Effect of Esomeprazole, Omeprazole or Lansoprazole on the Pharmacodynamics (PD) and Pharmacokinetics (PK) of Clopidogrel
Status: Completed Condition: Healthy

Safety and Efficacy of Lansoprazole 30mg Twice Daily in Treatment of Laryngitis Associated With Gastroesophageal Reflux
Status: Terminated Condition: Laryngopharyngeal Reflux

Dexlansoprazole to Treat Laryngopharyngeal Reflux and Lingual Tonsil Hypertrophy
Status: Not yet recruiting Condition: Laryngopharyngeal Reflux; Hypertrophy of Lingual Tonsil

Study Evaluating The Potential Effect Of Lansoprazole On The Pharmacokinetics Of Bosutinib In Healthy Subjects
Status: Completed Condition: Healthy

An Open Label pH Comparison of Esomeprazole and Lansoprazole in Barrett's Esophagus Patients
Status: Completed Condition: Barrett's Esophagus

Efficacy/Safety of Lansoprazole in Patients With Frequent Heartburn
Status: Completed Condition: Heartburn

A Study of Dexlansoprazole Modified Release Formulation to Treat Night Heartburn
Status: Completed Condition: Gastroesophageal Reflux

Treatment of Zollinger-Ellison Syndrome With Prevacid
Status: Completed Condition: Zollinger-Ellison Syndrome; Multiple Endocrine Neoplasia

Lansoprazole to Treat Children With Asthma
Status: Completed Condition: Asthma

Safety and Efficacy of Ilaprazole 5, 20 and 40 mg QD and Lansoprazole 30 mg QD on Healing of Erosive Esophagitis
Status: Completed Condition: Esophagitis

Effects of Lansoprazole on Sitagliptin Glucose-lowering Ability in Healthy Males: a Randomised Crossover Study
Status: Completed Condition: Healthy

Lansoprazole in Preterm Infants With Gastroesophageal Reflux (GER)
Status: Completed Condition: Premature Infants; Gastroesophageal Reflux

Twice Daily Prevacid for the Treatment of Laryngopharyngeal Reflux
Status: Completed Condition: Laryngopharyngeal Reflux

Efficacy of TAK-438, Amoxicillin and Clarithromycin in the First Line Eradication of H. Pylori
Status: Completed Condition: H. Pylori Infection

Efficacy and Safety of TAK-438 for the Prevention of Recurrent Gastric or Duodenal Ulcers During Therapy of Low-dose Aspirin
Status: Completed Condition: Gastric Ulcers; Duodenal Ulcers

Efficacy and Safety of TAK-438 for the Prevention of Recurrent Gastric or Duodenal Ulcers During Therapy of Non-steroidal Anti-inflammatory Drug (NSAID)
Status: Completed Condition: Gastric Ulcers; Duodenal Ulcers

Evaluation of 24-Hour Intragastric pH Using Esomeprazole, Lansoprazole, and Pantoprazole in Hispanic Patients With GERD
Status: Completed Condition: Gastroesophageal Reflux Disease

Study of 24-hour Intragastric pH Profiles of Esomeprazole 40 mg and Lansoprazole 30 mg in Healthy Volunteer Subjects
Status: Completed Condition: Healthy

Comparison of Prilosec Over-the-counter (OTC)® Versus Prevacid® for Gastric Acid Suppression
Status: Completed Condition: Healthy

Lansoprazole Preventing Gastroduodenal Stress Ulcerations
Status: Terminated Condition: Patients Undergoing Elective Coronary Artery Bypass Graft

Prevacid vs Lifestyle Modifications for the Treatment of LPR
Status: Recruiting Condition: Laryngopharyngeal Reflux

Long-term Extension Study of TAK-438 for the Prevention of Recurrent Gastric or Duodenal Ulcers During Therapy of Non-steroidal Anti-inflammatory Drug (NSAID)
Status: Completed Condition: Gastric Ulcers; Duodenal Ulcers

Long-term Extension Study of TAK-438 for the Prevention of Recurrent Gastric or Duodenal Ulcers During Therapy of Low-dose Aspirin
Status: Completed Condition: Gastric Ulcers; Duodenal Ulcers

Evaluation of Methods for the Determination of Chromogranin A in Routine Blood Samples
Status: Completed Condition: Neuroendocrine Carcinoma (Carcinoid)

PPI vs H2RA in Patients With Helicobacter Pylori-Negative Idiopathic Bleeding Ulcers
Status: Recruiting Condition: Peptic Ulcer

Evaluating Treatment Response in Laryngo-Pharyngeal Reflux
Status: Not yet recruiting Condition: Laryngopharyngeal Reflux

Can E-cadherin Found in Tissue/Blood be Valuable in Identifying & Monitoring Patients With Post-proton Pump Inhibitor (PPI)-Responsive Heartburn
Status: Completed Condition: Heartburn; Gastroesophageal Reflux Disease

A Comparison of Safety and Treatment in Subjects With Osteoarthritis Taking Low Dose Aspirin
Status: Completed Condition: Osteoarthritis; Peptic Ulcer

Dietary Control Alone Versus Dietary Control Plus Use of Proton Pump Inhibitors to Treat Pediatric Hoarseness
Status: Terminated Condition: Pediatric Dysphonia

Study of Anti-reflux Medication as a Potential Treatment for Glue Ear in Children
Status: Recruiting Condition: Otitis Media With Effusion

Study to Compare Gastric Inhibition of Two Proton Pump Inhibitors (CL2008-18)(P07815)(COMPLETED)
Status: Completed Condition: Human Experimentation

A Randomized, Double-Blind, Placebo-Controlled Study of Gastroesophageal Reflux Disease Therapy.
Status: Active, not recruiting Condition: Asthma

A Clinical Trial of Proton Pump Inhibitors to Treat Children With Chronic Otitis Media With Effusion
Status: Completed Condition: Otitis Media With Effusion

Oral vs Intravenous and Proton Pump Inhibitor (PPI)for Peptic Ulcer Bleeding (PUB)
Status: Active, not recruiting Condition: Upper Gastrointestinal Bleeding

Does Intensive Acid Suppression Reduce Esophageal Inflammation and Recurrent Barrett's Esophagus Following Ablation?
Status: Completed Condition: Inflammation; Barrett's Esophagus

Study of Acid Reflux Therapy for Children With Asthma
Status: Completed Condition: Asthma

Double the Dose of Clopidogrel or Switch to Prasugrel to Antagonize Proton Pump Inhibitor Interaction.
Status: Completed Condition: Anti Platelet Effects

The Frequency of Eosinophilic Esophagitis in Patients With Heartburn That is Refractory to Proton Pump Inhibitors
Status: Terminated Condition: Gastroesophageal Reflux Disease; Eosinophilic Esophagitis

Reflux Disease in Head and Neck Cancer Patients Undergoing Radiation Therapy
Status: Withdrawn Condition: Head and Neck Cancer; Oropharyngeal Cancer; Gastroesophageal Reflux Disease

Helicobacter Pylori Infection in Children With Chronic Idiopathic Thrombocytopenic Purpura
Status: Completed Condition: Chronic Idiopathic Thrombocytopenic Purpura; Helicobacter Pylori Infection

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Glossary
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Takeda Pharms Na
PREVACID NAPRAPAC 375 (COPACKAGED)
lansoprazole; naproxen
CAPSULE, DELAYED REL PELLETS, TABLET;ORAL021507Nov 14, 2003DISCNNo<disabled><disabled>
Takeda Pharms Na
PREVACID NAPRAPAC 500 (COPACKAGED)
lansoprazole; naproxen
CAPSULE, DELAYED REL PELLETS, TABLET;ORAL021507Nov 14, 2003DISCNNo<disabled><disabled>
Zydus Hlthcare
LANSOPRAZOLE
lansoprazole
CAPSULE, DELAYED REL PELLETS;ORAL202366Aug 19, 2013RXNo<disabled><disabled>
Mylan Pharms Inc
LANSOPRAZOLE
lansoprazole
CAPSULE, DELAYED REL PELLETS;ORAL090763Nov 10, 2009RXNo<disabled><disabled>
Takeda Pharms Usa
PREVACID
lansoprazole
TABLET, DELAYED RELEASE, ORALLY DISINTEGRATING;ORAL021428Aug 30, 2002RXNo7,875,292*PED<disabled>Y<disabled>
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