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Serving leading biopharmaceutical companies globally:

Queensland Health
US Army
Federal Trade Commission
Colorcon
Fish and Richardson
Farmers Insurance
Dow
Merck
Fuji
Healthtrust

Generated: November 18, 2017

DrugPatentWatch Database Preview

AMITIZA Drug Profile

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What is the patent landscape for Amitiza, and what generic Amitiza alternatives are available?

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

This drug has two hundred and eight patent family members in twenty-eight countries and seven supplementary protection certificates in six countries.

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

Summary for AMITIZA

Pharmacology for AMITIZA

Medical Subject Heading (MeSH) Categories for AMITIZA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sucampo Pharma Llc
AMITIZA
lubiprostone
CAPSULE;ORAL021908-001Jan 31, 2006RXYesYes► Subscribe► SubscribeY ► Subscribe
Sucampo Pharma Llc
AMITIZA
lubiprostone
CAPSULE;ORAL021908-001Jan 31, 2006RXYesYes► Subscribe► SubscribeY ► Subscribe
Sucampo Pharma Llc
AMITIZA
lubiprostone
CAPSULE;ORAL021908-001Jan 31, 2006RXYesYes► Subscribe► SubscribeY ► Subscribe
Sucampo Pharma Llc
AMITIZA
lubiprostone
CAPSULE;ORAL021908-001Jan 31, 2006RXYesYes► Subscribe► SubscribeY ► Subscribe
Sucampo Pharma Llc
AMITIZA
lubiprostone
CAPSULE;ORAL021908-002Apr 29, 2008RXYesNo► Subscribe► Subscribe ► Subscribe
Sucampo Pharma Llc
AMITIZA
lubiprostone
CAPSULE;ORAL021908-001Jan 31, 2006RXYesYes► Subscribe► Subscribe ► Subscribe
Sucampo Pharma Llc
AMITIZA
lubiprostone
CAPSULE;ORAL021908-001Jan 31, 2006RXYesYes► Subscribe► SubscribeY ► Subscribe
Sucampo Pharma Llc
AMITIZA
lubiprostone
CAPSULE;ORAL021908-002Apr 29, 2008RXYesNo► Subscribe► SubscribeY ► Subscribe
Sucampo Pharma Llc
AMITIZA
lubiprostone
CAPSULE;ORAL021908-002Apr 29, 2008RXYesNo► Subscribe► Subscribe ► Subscribe
Sucampo Pharma Llc
AMITIZA
lubiprostone
CAPSULE;ORAL021908-002Apr 29, 2008RXYesNo► Subscribe► SubscribeY ► Subscribe
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Expired Patents for Tradename: AMITIZA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sucampo Pharma Llc
AMITIZA
lubiprostone
CAPSULE;ORAL021908-002Apr 29, 2008► Subscribe► Subscribe
Sucampo Pharma Llc
AMITIZA
lubiprostone
CAPSULE;ORAL021908-001Jan 31, 2006► Subscribe► Subscribe
Sucampo Pharma Llc
AMITIZA
lubiprostone
CAPSULE;ORAL021908-002Apr 29, 2008► Subscribe► Subscribe
Sucampo Pharma Llc
AMITIZA
lubiprostone
CAPSULE;ORAL021908-001Jan 31, 2006► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges 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
6,610,732 Anti-constipation composition► Subscribe
7,253,295Chloride channel opener► Subscribe
8,748,454Anti-constipation composition► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: AMITIZA

Country Document Number Estimated Expiration
Australia7685600► Subscribe
Canada2444103► Subscribe
Japan4684334► Subscribe
Japan2006513232► Subscribe
Hungary229319► Subscribe
Japan4332353► Subscribe
Japan2004508327► Subscribe
South Korea20080090526► Subscribe
Portugal1392318► Subscribe
Argentina089848► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: AMITIZA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00757Netherlands► SubscribePRODUCT NAME: LUBIPROSTON; NAT. REGISTRATION NO/DATE: RVG 115891 20150317; FIRST REGISTRATION:
2015000080Germany► SubscribePRODUCT NAME: LUBIPROSTON, ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; NAT. REGISTRATION NO/DATE: 92699.00.00 20150519; FIRST REGISTRATION: VEREINIGTES KOENIGREICH PL 21341/0003 20120910
826Luxembourg► SubscribePRODUCT NAME: LUBIPROSTONE, INCLUANT LES SELS PHARMACEUTIQUEMENT ACCEPTABLES, LES ESTERS OU LES AMIDES DE LA LUBIPROSTONE. FIRST REGISTRATION: 20120910
0757Netherlands► SubscribePRODUCT NAME: LUBIPROSTON; NATIONAL REGISTRATION NO/DATE: RVG 115891; FIRST REGISTRATION NO/DATE: PL21341/0003 20120910
/2015Austria► SubscribePRODUCT NAME: LUBIPROSTON UND PHARMAZEUTISCH ANNEHMBARE SALZE DAVON; NAT. REGISTRATION NO/DATE: 136176 20150508; FIRST REGISTRATION: GB PL 21341/0003 20120910
15/028Ireland► SubscribePRODUCT NAME: LUBIPROSTONE AND PHARMACEUTICALLY ACCEPTABLE SALTS FOR LUBIPROSTONE.; NAT REGISTRATION NO/DATE: PA148/002/001 20150213; FIRST REGISTRATION NO/DATE: PL21341/0003-0001 20120910
1315485/01Switzerland► SubscribeFORMER REPRESENTATIVE: BOHEST AG, CH
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Medtronic
Cipla
Boehringer Ingelheim
McKesson
Accenture
Cantor Fitzgerald
Queensland Health
US Department of Justice
Deloitte
Johnson and Johnson

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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