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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-six patent family members in twenty-six countries.

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

Summary for Generic Name: lubiprostone

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: Active, not recruiting 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

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

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

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
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
CAPSULE;ORAL021908-002Apr 29, 2008RXNo8,748,481<disabled> <disabled>
Sucampo Pharma Llc
CAPSULE;ORAL021908-002Apr 29, 2008RXNo7,064,148<disabled> <disabled>
Sucampo Pharma Llc
CAPSULE;ORAL021908-001Jan 31, 2006RXYes6,414,016<disabled> <disabled>
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International Patent Family for Ingredient: lubiprostone

Country Document Number Publication Date
Japan4684334May 18, 2011
World Intellectual Property Organization (WIPO)2004060377Jul 22, 2004
European Patent Office1575596Sep 21, 2005
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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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