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Lubiprostone - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for lubiprostone?

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.

This ingredient has one hundred and eighty-five patent family members in twenty-seven countries.

There are eight 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 list8
Suppliers / Packagers: see list7
Bulk Api Vendors: see list59
Clinical Trials: see list26
Patent Applications: see list414
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 Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sucampo Pharma Llc
AMITIZA
lubiprostone
CAPSULE;ORAL021908-002Apr 29, 2008RXYesNo8,026,393► SubscribeY ► Subscribe
Sucampo Pharma Llc
AMITIZA
lubiprostone
CAPSULE;ORAL021908-001Jan 31, 2006RXYesYes8,748,481► Subscribe ► Subscribe
Sucampo Pharma Llc
AMITIZA
lubiprostone
CAPSULE;ORAL021908-001Jan 31, 2006RXYesYes8,071,613► Subscribe ► Subscribe
Sucampo Pharma Llc
AMITIZA
lubiprostone
CAPSULE;ORAL021908-002Apr 29, 2008RXYesNo8,748,481► Subscribe ► Subscribe
Sucampo Pharma Llc
AMITIZA
lubiprostone
CAPSULE;ORAL021908-002Apr 29, 2008RXYesNo8,114,890► 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;ORAL021908-001Jan 31, 20065,284,858► Subscribe
Sucampo Pharma Llc
AMITIZA
lubiprostone
CAPSULE;ORAL021908-002Apr 29, 20085,317,032► Subscribe
Sucampo Pharma Llc
AMITIZA
lubiprostone
CAPSULE;ORAL021908-001Jan 31, 20065,317,032► Subscribe
Sucampo Pharma Llc
AMITIZA
lubiprostone
CAPSULE;ORAL021908-002Apr 29, 20085,284,858► 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
8,748,454Anti-constipation composition► Subscribe
6,610,732 Anti-constipation composition► Subscribe
6,923,654 Manikin and eye device apparatus, methods and articles of manufacture► Subscribe
7,371,069Manikin and eye device apparatus, methods and articles of manufacture► Subscribe
7,253,295Chloride channel opener► 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
Argentina089848► Subscribe
Australia8261501► Subscribe
Canada2637274► Subscribe
China1379769► Subscribe
European Patent Office2281564► 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
826Luxembourg► SubscribePRODUCT NAME: LUBIPROSTONE, INCLUANT LES SELS PHARMACEUTIQUEMENT ACCEPTABLES, LES ESTERS OU LES AMIDES DE LA LUBIPROSTONE. FIRST REGISTRATION: 20120910
00757Netherlands► SubscribePRODUCT NAME: LUBIPROSTON; NAT. REGISTRATION NO/DATE: RVG 115891 20150317; FIRST REGISTRATION:
/2015Austria► SubscribePRODUCT NAME: LUBIPROSTON UND PHARMAZEUTISCH ANNEHMBARE SALZE DAVON; NAT. REGISTRATION NO/DATE: 136176 20150508; FIRST REGISTRATION: GB PL 21341/0003 20120910
1315485/01Switzerland► SubscribeFORMER REPRESENTATIVE: BOHEST AG, CH
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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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