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Serving 500+ biopharmaceutical companies globally:

Citi
Accenture
Cerilliant
Colorcon
Merck
US Department of Justice
US Army
Baxter
Julphar
Novartis

Generated: August 20, 2017

DrugPatentWatch Database Preview

LINZESS Drug Profile

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What is the patent landscape for Linzess, and when can generic versions of Linzess launch?

Linzess is a drug marketed by Forest Labs Llc and is included in one NDA. There are nine patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and twenty-two patent family members in thirty-four countries.

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

Summary for Tradename: LINZESS

Patents:9
Applicants:1
NDAs:1
Suppliers / Packagers: see list3
Bulk Api Vendors: see list2
Clinical Trials: see list8
Patent Applications: see list1
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:LINZESS at DailyMed

Pharmacology for Tradename: LINZESS

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Forest Labs Llc
LINZESS
linaclotide
CAPSULE;ORAL202811-002Aug 30, 2012RXYesYes► Subscribe► Subscribe ► Subscribe
Forest Labs Llc
LINZESS
linaclotide
CAPSULE;ORAL202811-002Aug 30, 2012RXYesYes► Subscribe► SubscribeY ► Subscribe
Forest Labs Llc
LINZESS
linaclotide
CAPSULE;ORAL202811-002Aug 30, 2012RXYesYes► Subscribe► SubscribeY ► Subscribe
Forest Labs Llc
LINZESS
linaclotide
CAPSULE;ORAL202811-003Jan 25, 2017RXYesNo► Subscribe► SubscribeYY ► Subscribe
Forest Labs Llc
LINZESS
linaclotide
CAPSULE;ORAL202811-001Aug 30, 2012RXYesNo► Subscribe► Subscribe ► Subscribe
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Paragraph IV activity for: LINZESS

Drugname Dosage Strength RLD Submissiondate
linaclotideCapsules145 mcg and 290 mcgLinzess8/30/2016

Non-Orange Book Patents for Tradename: LINZESS

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

Country Document Number Estimated Expiration
South Korea20110114682► Subscribe
Singapore193801► Subscribe
South Africa200506714► Subscribe
Israel211028► Subscribe
South Africa200805859► 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: LINZESS

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
201Luxembourg► SubscribePRODUCT NAME: LINACLOTIDE ET TOUTE FORME THERAPEUTIQUE EQUIVALENTE DE CELUICI,PROTETE PAR LE BREVET DE BASE,Y COMPRIS DES SELS PHARMACEUTIQUEMENT ACCEPTABLES
2013000045Germany► SubscribePRODUCT NAME: LINACLOTID UND JEDE THERAPEUTISCH AEQUIVALENTE FORM DAVON, WELCHE DURCH DAS GRUNDPATENT GESCHUETZT IST, EINSCHLIESSLICH DESSEN PHARMAZEUTISCH VERTRAEGLICHE SALZE; REGISTRATION NO/DATE: EU/1/12/801/001-004 20121126
2013 00027Denmark► Subscribe
0594Netherlands► SubscribePRODUCT NAME: LINACLOTIDE; REGISTRATION NO/DATE: EU/1/12/801/001-004 20121126
6Finland► Subscribe
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

McKesson
Fish and Richardson
Julphar
Moodys
Farmers Insurance
Cipla
McKinsey
Chubb
Accenture
Daiichi Sankyo

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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