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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-three 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

Tradenames:1
Patents:17
Applicants:1
NDAs:1
Drug Master File Entries: see list7
Suppliers: see list5
Therapeutic Class:Gastrointestinal Agents

Pharmacology for Ingredient: lubiprostone

Clinical Trials for: lubiprostone

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;ORAL021908-002Apr 29, 2008RXNo6,583,174<disabled>Y<disabled>
Sucampo Pharma Llc
AMITIZA
lubiprostone
CAPSULE;ORAL021908-002Apr 29, 2008RXNo8,088,934<disabled>Y<disabled>
Sucampo Pharma Llc
AMITIZA
lubiprostone
CAPSULE;ORAL021908-001Jan 31, 2006RXYes8,779,187<disabled>Y<disabled>
Sucampo Pharma Llc
AMITIZA
lubiprostone
CAPSULE;ORAL021908-002Apr 29, 2008RXNo8,071,613<disabled><disabled>
Sucampo Pharma Llc
AMITIZA
lubiprostone
CAPSULE;ORAL021908-001Jan 31, 2006RXYes8,338,639<disabled>Y<disabled>
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International Patent Family for Ingredient: lubiprostone

Country Document Number Publication Date
South Korea100901102Jun 08, 2009
Portugal1857105Oct 08, 2010
Canada2510051Jul 22, 2004
South Korea101393944May 12, 2014
Hong Kong1045693Jan 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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