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Linaclotide - Generic Drug Details

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

Linaclotide is the generic ingredient in one branded drug marketed by Forest Labs Llc and is included in one NDA. There are ten patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Linaclotide has one hundred and sixteen patent family members in thirty-four countries.

There are eight drug master file entries for linaclotide. Three suppliers are listed for this compound.

Summary for Generic Name: linaclotide

Tradenames:1
Patents:10
Applicants:1
NDAs:1
Drug Master File Entries: see list8
Suppliers / Packagers: see list3
Bulk Api Vendors: see list7
Clinical Trials: see list15
Patent Applications: see list24
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:linaclotide at DailyMed

Pharmacology for Ingredient: linaclotide

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Forest Labs Llc
LINZESS
linaclotide
CAPSULE;ORAL202811-001Aug 30, 2012RXYesNo7,704,947► SubscribeYY ► Subscribe
Forest Labs Llc
LINZESS
linaclotide
CAPSULE;ORAL202811-002Aug 30, 2012RXYesYes8,933,030► SubscribeY ► Subscribe
Forest Labs Llc
LINZESS
linaclotide
CAPSULE;ORAL202811-001Aug 30, 2012RXYesNo7,304,036► SubscribeYY ► Subscribe
Forest Labs Llc
LINZESS
linaclotide
CAPSULE;ORAL202811-002Aug 30, 2012RXYesYes7,304,036► SubscribeYY ► Subscribe
Forest Labs Llc
LINZESS
linaclotide
CAPSULE;ORAL202811-001Aug 30, 2012RXYesNo8,748,573► Subscribe ► Subscribe
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Non-Orange Book Patents for Generic Ingredient: linaclotide

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
2,014,073,571► Subscribe
7,772,188Methods and compositions for the treatment of gastrointestinal disorders► Subscribe
7,910,546Methods and compositions for the treatment of gastrointestinal disorders► 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: linaclotide

Country Document Number Estimated Expiration
European Patent Office1730172► Subscribe
China102020704► Subscribe
Russian Federation2543350► Subscribe
Canada2732892► Subscribe
Denmark1594517► 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: LINACLOTIDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
6Finland► Subscribe
2013014Lithuania► SubscribePRODUCT NAME: LINACLOTIDUM; REGISTRATION NO/DATE: EU/1/12/801/001 - EU/1/12/801/004 20121126
0593Netherlands► SubscribePRODUCT NAME: LINACLOTIDE; REGISTRATION NO/DATE: EU/1/12/801/001-004 20121126
2013 00027Denmark► Subscribe
90024-6Sweden► SubscribePRODUCT NAME: LINAKLOTID; REG. NO/DATE: EU/1/12/801/001 20121126
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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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