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Lubiprostone - Generic Drug Details

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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 patent family members in twenty-six countries.

There are seven drug master file entries for lubiprostone. Six suppliers are listed for this compound.

Summary for Generic Name: lubiprostone

Tradenames:1
Patents:16
Applicants:1
NDAs:1
Drug Master File Entries: see list7
Suppliers / Packaging: see list6
Therapeutic Class:Gastrointestinal Agents

Pharmacology for Ingredient: lubiprostone

Clinical Trials for: lubiprostone

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, 2006RXYes6,414,016<disabled> <disabled>
Sucampo Pharma Llc
AMITIZA
lubiprostone
CAPSULE;ORAL021908-002Apr 29, 2008RXNo7,064,148<disabled> <disabled>
Sucampo Pharma Llc
AMITIZA
lubiprostone
CAPSULE;ORAL021908-001Jan 31, 2006RXYes8,748,481<disabled> <disabled>
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Expired Orange Book Patents for Generic Ingredient: lubiprostone

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Sucampo Pharma Llc
AMITIZA
lubiprostone
CAPSULE;ORAL021908-002Apr 29, 20085,317,032<disabled>
Sucampo Pharma Llc
AMITIZA
lubiprostone
CAPSULE;ORAL021908-001Jan 31, 20065,284,858<disabled>
Sucampo Pharma Llc
AMITIZA
lubiprostone
CAPSULE;ORAL021908-001Jan 31, 20065,317,032<disabled>
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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<disabled in preview>
8,748,454Anti-constipation composition<disabled in preview>
7,253,295Chloride channel opener<disabled in preview>
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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
Argentina026046<disabled in preview>
Israel181332<disabled in preview>
Denmark1857105<disabled in preview>
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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
00757Netherlands<disabled>PRODUCT NAME: LUBIPROSTON; NAT. REGISTRATION NO/DATE: RVG 115891 20150317; FIRST REGISTRATION:
/2015Austria<disabled>PRODUCT NAME: LUBIPROSTON UND PHARMAZEUTISCH ANNEHMBARE SALZE DAVON; NAT. REGISTRATION NO/DATE: 136176 20150508; FIRST REGISTRATION: GB PL 21341/0003 20120910
1315485/01Switzerland<disabled>FORMER REPRESENTATIVE: BOHEST AG, CH
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