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Profile for Tradename: AMITIZA

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Amitiza is a drug marketed by Sucampo Pharma Llc and is included in one NDA. It is available from five suppliers. There are seventeen patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and eigthy-six patent family members in twenty-six countries.

The generic ingredient in AMITIZA is lubiprostone. There are seven drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the lubiprostone profile page.

Summary for Tradename: AMITIZA

Suppliers / Packagers: see list10

Pharmacology for Tradename: AMITIZA

Clinical Trials for: AMITIZA

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

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

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

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

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

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

A Trial Comparing Split-Dose Miralax With Amitiza Pretreatment Versus Dulcolax Pretreatment Versus Golytely for Bowel Cleansing Prior to Colonoscopy
Status: Completed Condition: Colonoscopy

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

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

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

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;ORAL021908-001Jan 31, 2006RXYes5,284,858<disabled>Y <disabled>
Sucampo Pharma Llc
CAPSULE;ORAL021908-001Jan 31, 2006RXYes8,097,649<disabled>Y <disabled>
Sucampo Pharma Llc
CAPSULE;ORAL021908-001Jan 31, 2006RXYes8,338,639<disabled>Y <disabled>
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Paragraph IV activity for: AMITIZA

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

International Patent Family for Tradename: AMITIZA

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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