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Profile for Tradename: AMITIZA

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Summary for Tradename: AMITIZA

Patents:17
Applicants:1
NDAs:1
Suppliers: see list5

Pharmacology for Tradename: AMITIZA

Clinical Trials for: AMITIZA

Comparative Study of Lubiprostone and PEG Preparation Versus Conventional PEG Preparation for Colonoscopy
Status: Completed Condition: Colorectal Carcinoma

Effect of Lubiprostone on Small Bowel Contractions in Female Patients With Constipation Irritable Bowel Syndrome (C-IBS)
Status: Completed Condition: Constipation-predominant Irritable Bowel Syndrome

Amitiza® Plus GoLYTELY® Versus Placebo Plus GoLYTELY® for Outpatient Colonoscopy Preparation
Status: Completed Condition: Colonoscopy

Lubiprostone Effect on Gastrointestinal (GI) Tract Transit Times Measured by Smartpill in Patients With Chronic Constipation
Status: Active, not recruiting Condition: Chronic Idiopathic Constipation

Lubiprostone, Colonic Motility and Sensation
Status: Completed Condition: Healthy

Lubiprostone in Patients With Multiple Sclerosis Associated Constipation
Status: Recruiting Condition: Multiple Sclerosis; Constipation

Amitiza in Constipation Associated With PD (Parkinson's Disease)
Status: Completed Condition: Parkinson's Disease

The Effectiveness of Lubiprostone in Constipated Diabetics
Status: Recruiting Condition: Constipation; Diabetes

Effects of Lubiprostone on Gastrointestinal Transit & pH in Irritable Bowel Syndrome (IBS) With Constipation
Status: Completed Condition: Adult; Irritable Bowel Syndrome; Constipation

Lubiprostone (Amitiza®) Vs. Standard Care in Opioid-induced Constipation After Surgery in Inpatient Rehabilitation
Status: Completed Condition: Constipation

Courtesy of ClinicalTrials.org
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Glossary
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sucampo Pharma Llc
AMITIZA
lubiprostone
CAPSULE;ORAL021908Jan 31, 2006RXYes8,779,187<disabled>Y<disabled>
Sucampo Pharma Llc
AMITIZA
lubiprostone
CAPSULE;ORAL021908Apr 29, 2008RXNo6,583,174<disabled>Y<disabled>
Sucampo Pharma Llc
AMITIZA
lubiprostone
CAPSULE;ORAL021908Apr 29, 2008RXNo8,088,934<disabled>Y<disabled>
Sucampo Pharma Llc
AMITIZA
lubiprostone
CAPSULE;ORAL021908Jan 31, 2006RXYes8,097,649<disabled>Y<disabled>
Sucampo Pharma Llc
AMITIZA
lubiprostone
CAPSULE;ORAL021908Apr 29, 2008RXNo8,114,890<disabled>Y<disabled>
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Paragraph IV activity for: AMITIZA

Drugname Dosage Strength RLD Submissiondate
lubiprostoneCapsules8 mcg and 24 mcgAmitiza8/20/2012
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