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Details for Patent: 5,284,858

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Patent 5,284,858 protects AMITIZA and is included in one NDA. There has been one Paragraph IV challenge on Amitiza.

This patent has nine patent family members in eight countries.

Summary for Patent: 5,284,858

Title: Prostaglandins E and anti ulcers containing same
Abstract:The novel 13, 14-dihydro-15-keto prostaglandins E of the invention have remarkable preventive effects against ulcers. Further, the novel 13,14-dihydro-15-ketoprostaglandins E of the invention have an advatage that they have none of side effects which prostaglandin E intrinsically has, or can remarakably reduce such effects of the prostaglandin E. Therefore, the novel 13, 14-dihydro-15-keto prostaglandins E of the invention are effective for animal and human use for treatment and prevention of ulcers, such as duodenal ulcer and gastric ulcer.
Inventor(s): Ueno; Ryuzo (Nishinomiya, JP), Ueno; Ryuji (Kyoto, JP), Kato; Ichie (Kawanishi, JP), Oda; Tomio (Itami, JP)
Assignee: Kabushiki Kaisha Ueno Seiyaku Oyo Kenkyujo (Osaka, JP)
Application Number:07/925,220
Patent Claim Types:
see list of patent claims
Compound; Composition; Use;
Patent PDF download available with subscription

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Patented / Exclusive Use
Sucampo Pharma Llc
AMITIZA
lubiprostone
CAPSULE;ORAL021908-002Apr 29, 2008RXNo5,284,858<disabled>Y
Sucampo Pharma Llc
AMITIZA
lubiprostone
CAPSULE;ORAL021908-001Jan 31, 2006RXYes5,284,858<disabled>Y
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Foreign Priority and PCT Information for Patent: 5,284,858

Foriegn Application Priority Data
Foreign Country Foreign Patent Number Foreign Patent Date
Japan62-18820Jan 28, 1987
Japan62-65352Mar 18, 1987

Non-Orange Book Patents for Patent: 5,284,858

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,265,440 Prostaglandins E and anti ulcers containing same<disabled in preview>
5,166,174 Prostaglandins E and anti-ulcers containing same<disabled in preview>
5,380,709 Prostaglandins E and anti ulcers containing same<disabled in preview>
5,428,062 Prostaglandins E and anti ulcers containing same<disabled in preview>
5,225,439 Prostaglandins E and anti ulcers containing same<disabled in preview>
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International Patent Family for Patent: 5,284,858

Country Document Number Publication Date Supplementary Protection Certificate SPC Country SPC Expiration
European Patent Office0284180Aug 19, 1992
JapanH0688966Nov 09, 1994
Greece3005677Jun 07, 1993
Austria79610Sep 15, 1992
JapanS6452753Feb 28, 1989
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Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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