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AMITIZA Drug Profile

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

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

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

Summary for Tradename: AMITIZA

Patents:16
Applicants:1
NDAs:1
Suppliers / Packagers: see list6

Pharmacology for Tradename: AMITIZA

Clinical Trials for: AMITIZA

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;ORAL021908-001Jan 31, 2006RXYes6,583,174<disabled>Y <disabled>
Sucampo Pharma Llc
AMITIZA
lubiprostone
CAPSULE;ORAL021908-001Jan 31, 2006RXYes8,026,393<disabled>Y <disabled>
Sucampo Pharma Llc
AMITIZA
lubiprostone
CAPSULE;ORAL021908-001Jan 31, 2006RXYes8,114,890<disabled>Y <disabled>
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Expired Patents for Tradename: AMITIZA

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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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Paragraph IV activity for: AMITIZA

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

Non-Orange Book Patents for Tradename: AMITIZA

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
6,923,654 Manikin and eye device apparatus, methods and articles of manufacture<disabled in preview>
6,610,732 Anti-constipation composition<disabled in preview>
7,253,295Chloride channel opener<disabled in preview>
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International Patent Family for Tradename: AMITIZA

Country Document Number Estimated Expiration
Norway20034864<disabled in preview>
Brazil0214075<disabled in preview>
South Korea20120045051<disabled in preview>
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Supplementary Protection Certificates for Tradename: AMITIZA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
/2015Austria<disabled>PRODUCT NAME: LUBIPROSTON UND PHARMAZEUTISCH ANNEHMBARE SALZE DAVON; NAT. REGISTRATION NO/DATE: 136176 20150508; FIRST REGISTRATION: GB PL 21341/0003 20120910
00757Netherlands<disabled>PRODUCT NAME: LUBIPROSTON; NAT. REGISTRATION NO/DATE: RVG 115891 20150317; FIRST REGISTRATION:
826Luxembourg<disabled>PRODUCT NAME: LUBIPROSTONE, INCLUANT LES SELS PHARMACEUTIQUEMENT ACCEPTABLES, LES ESTERS OU LES AMIDES DE LA LUBIPROSTONE. FIRST REGISTRATION: 20120910
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