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Details for Generic Name: lubiprostone

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Lubiprostone is the generic ingredient in one branded drug marketed by Sucampo Pharma Llc and is included in one NDA. There are seventeen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

This ingredient has one hundred and eigthy-seven patent family members in twenty-seven countries.

There are seven drug master file entries for lubiprostone. Five suppliers are listed for this compound.

Summary for Generic Name: lubiprostone

Tradenames:1
Patents:17
Applicants:1
NDAs:1
Drug Master File Entries: see list7
Suppliers / Packaging: see list10
Therapeutic Class:Gastrointestinal Agents

Pharmacology for Ingredient: lubiprostone

Clinical Trials for: lubiprostone

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

Lubiprostone Effect on Gastrointestinal (GI) Tract Transit Times Measured by Smartpill in Patients With Chronic Constipation
Status: Completed Condition: Chronic Idiopathic Constipation

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

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

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

Effect of Lubiprostone on Methanogenesis and Bowel Function in Chronic Constipation.
Status: Recruiting Condition: Chronic Constipation, Methanogenesis

Lubiprostone for the Treatment of Chronic Idiopathic Constipation
Status: Not yet recruiting Condition: Constipation

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

Lubiprostone Effects on Visceral Pain Sensitivity
Status: Completed Condition: Irritable Bowel Syndrome

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
Sucampo Pharma Llc
AMITIZA
lubiprostone
CAPSULE;ORAL021908-002Apr 29, 2008RXNo6,583,174<disabled>Y <disabled>
Sucampo Pharma Llc
AMITIZA
lubiprostone
CAPSULE;ORAL021908-002Apr 29, 2008RXNo8,097,649<disabled>Y <disabled>
Sucampo Pharma Llc
AMITIZA
lubiprostone
CAPSULE;ORAL021908-001Jan 31, 2006RXYes8,114,890<disabled>Y <disabled>
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Expired Orange Book Patents for Generic Ingredient: lubiprostone

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
Sucampo Pharma Llc
AMITIZA
lubiprostone
CAPSULE;ORAL021908-001Jan 31, 20065,317,032<disabled>
Sucampo Pharma Llc
AMITIZA
lubiprostone
CAPSULE;ORAL021908-002Apr 29, 20085,284,858<disabled>
Sucampo Pharma Llc
AMITIZA
lubiprostone
CAPSULE;ORAL021908-001Jan 31, 20065,284,858<disabled>
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International Patent Family for Ingredient: lubiprostone

Country Document Number Publication Date
BrazilPI0514891Jun 24, 2008
South Africa200702625Aug 27, 2008
Israel181332Jul 04, 2007
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.

Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided information. There is no warranty that the information contained herein is error free. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

Copyright 2002-2016 thinkBiotech LLC
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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