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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 forty-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
Formulation / Manufacturing:see details

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

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

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

Efficacy and Safety of Vonoprazan Compared to Lansoprazole in the Maintenance Treatment of Erosive Esophagitis
Status: Not yet recruiting Condition: Erosive Esophagitis

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

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

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

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

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

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

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

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Status: Withdrawn Condition: Chest Pain; Gastrointestinal Reflux Disease

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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: Completed Condition: Gastroesophageal Reflux Disease; Erosive Esophagitis

Efficacy and Safety of Oral Once-Daily Vonoprazan (TAK-438) in Patients With Erosive Esophagitis
Status: Not yet recruiting Condition: Erosive Esophagitis

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

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

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

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

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

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

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

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

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

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

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

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

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

Safety and Efficacy of Dexlansoprazole Modified Release Formulation to Treat Heartburn
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

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

Safety and Efficacy of Dexlansoprazole Modified Release Formulation to Treat Gastroesophageal Reflux Disease
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

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

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

Open-label PK Study to Evaluate Lansoprazole and Neratinib in Healthy Subjects
Status: Completed Condition: Healthy

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

Dexlansoprazole in Asian Participants With Gastroesophageal Reflux Disease
Status: Recruiting Condition: Gastroesophageal Reflux Disease

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

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

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

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

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

Effect of Dexlansoprazole on Bone Homeostasis
Status: Completed Condition: Homeostasis; Bone and Bones

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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: 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

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

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

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

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

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

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

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
Sandoz
LANSOPRAZOLE
lansoprazole
CAPSULE, DELAYED REL PELLETS;ORAL090331-002Apr 23, 2010RXNo<disabled><disabled>
Takeda Pharms Usa
PREVACID
lansoprazole
TABLET, DELAYED RELEASE, ORALLY DISINTEGRATING;ORAL021428-001Aug 30, 2002RXNo7,399,485*PED<disabled>Y<disabled>
Takeda Pharms Na
PREVACID
lansoprazole
FOR SUSPENSION, DELAYED RELEASE;ORAL021281-002May 3, 2001DISCNNo<disabled><disabled>
Takeda Pharms Usa
PREVACID
lansoprazole
TABLET, DELAYED RELEASE, ORALLY DISINTEGRATING;ORAL021428-001Aug 30, 2002RXNo7,875,292*PED<disabled>Y<disabled>
Takeda Pharms Usa
PREVACID
lansoprazole
TABLET, DELAYED RELEASE, ORALLY DISINTEGRATING;ORAL021428-002Aug 30, 2002RXYes6,328,994*PED<disabled>Y<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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