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Serving 500+ biopharmaceutical companies globally:

Citi
Johnson and Johnson
Chubb
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Cerilliant
Colorcon
Fish and Richardson
Daiichi Sankyo
Cipla

Generated: July 27, 2017

DrugPatentWatch Database Preview

Lubiprostone - Generic Drug Details

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What are the generic drug sources for lubiprostone and what is the scope of lubiprostone patent protection?

Lubiprostone
is the generic ingredient in one branded drug marketed by Sucampo Pharma Llc and is included in one NDA. There are sixteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Lubiprostone has one hundred and eighty-eight patent family members in twenty-eight countries.

There are nine drug master file entries for lubiprostone. Seven suppliers are listed for this compound.

Summary for Generic Name: lubiprostone

Tradenames:1
Patents:16
Applicants:1
NDAs:1
Drug Master File Entries: see list9
Suppliers / Packagers: see list7
Bulk Api Vendors: see list59
Clinical Trials: see list43
Patent Applications: see list671
Therapeutic Class:Gastrointestinal Agents
Drug Prices:see low prices
DailyMed Link:lubiprostone at DailyMed

Pharmacology for Ingredient: lubiprostone

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;ORAL021908-002Apr 29, 2008RXYesNo► Subscribe► Subscribe ► 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► SubscribeY ► 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
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Expired Orange Book Patents for Generic Ingredient: lubiprostone

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;ORAL021908-001Jan 31, 2006► Subscribe► Subscribe
Sucampo Pharma Llc
AMITIZA
lubiprostone
CAPSULE;ORAL021908-002Apr 29, 2008► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: lubiprostone

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► Subscribe
6,610,732 Anti-constipation composition► Subscribe
7,253,295Chloride channel opener► Subscribe
7,371,069Manikin and eye device apparatus, methods and articles of manufacture► 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 Ingredient: lubiprostone

Country Document Number Estimated Expiration
Canada2385732► Subscribe
Canada2577284► Subscribe
Portugal1978944► Subscribe
Japan4786866► Subscribe
World Intellectual Property Organization (WIPO)2004060377► 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: LUBIPROSTONE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
/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
00757Netherlands► SubscribePRODUCT NAME: LUBIPROSTON; NAT. REGISTRATION NO/DATE: RVG 115891 20150317; FIRST REGISTRATION:
826Luxembourg► SubscribePRODUCT NAME: LUBIPROSTONE, INCLUANT LES SELS PHARMACEUTIQUEMENT ACCEPTABLES, LES ESTERS OU LES AMIDES DE LA LUBIPROSTONE. FIRST REGISTRATION: 20120910
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
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Johnson and Johnson
Express Scripts
Boehringer Ingelheim
McKesson
Harvard Business School
Daiichi Sankyo
Medtronic
Cipla
Dow
Teva

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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