.

BioPharmaceutical Business Intelligence

  • Analyze global market entry opportunities
  • Identify first generic entrants
  • Uncover prior art in expired and abandoned patents

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Serving leading biopharmaceutical companies globally:

Fuji
Express Scripts
Mallinckrodt
McKesson
Harvard Business School
Boehringer Ingelheim
Cipla
Fish and Richardson
Julphar
Queensland Health

Generated: November 17, 2017

DrugPatentWatch Database Preview

Linaclotide - Generic Drug Details

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What are the generic drug sources for linaclotide and what is the scope of linaclotide freedom to operate?

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 forty-seven patent family members in thirty-six countries and thirteen supplementary protection certificates in seven countries.

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

Pharmacology for linaclotide

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;ORAL202811-003Jan 25, 2017RXYesNo► Subscribe► Subscribe► Subscribe
Forest Labs Llc
LINZESS
linaclotide
CAPSULE;ORAL202811-002Aug 30, 2012RXYesYes► Subscribe► SubscribeYY ► Subscribe
Forest Labs Llc
LINZESS
linaclotide
CAPSULE;ORAL202811-002Aug 30, 2012RXYesYes► Subscribe► SubscribeYY ► Subscribe
Forest Labs Llc
LINZESS
linaclotide
CAPSULE;ORAL202811-001Aug 30, 2012RXYesNo► Subscribe► SubscribeYY ► Subscribe
Forest Labs Llc
LINZESS
linaclotide
CAPSULE;ORAL202811-003Jan 25, 2017RXYesNo► Subscribe► SubscribeY ► Subscribe
Forest Labs Llc
LINZESS
linaclotide
CAPSULE;ORAL202811-001Aug 30, 2012RXYesNo► Subscribe► Subscribe► Subscribe
Forest Labs Llc
LINZESS
linaclotide
CAPSULE;ORAL202811-002Aug 30, 2012RXYesYes► Subscribe► SubscribeYY ► 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► SubscribeY ► Subscribe
Forest Labs Llc
LINZESS
linaclotide
CAPSULE;ORAL202811-003Jan 25, 2017RXYesNo► Subscribe► 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
7,910,546Methods and compositions for the treatment of gastrointestinal disorders► Subscribe
7,772,188Methods 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
South Korea101704832► Subscribe
Hong Kong1219062► Subscribe
Poland2776055► Subscribe
Hong Kong1161978► Subscribe
Russian Federation2008147983► Subscribe
Australia2009282446► Subscribe
Israel221380► Subscribe
Spain2387848► Subscribe
Japan4584911► Subscribe
Germany602004007105► 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
2013014Lithuania► SubscribePRODUCT NAME: LINACLOTIDUM; REGISTRATION NO/DATE: EU/1/12/801/001 - EU/1/12/801/004 20121126
200Luxembourg► SubscribePRODUCT NAME: LINACLOTIDE ET TOUTE FORME THERAPEUTIQUE EQUIVALENTE DE CELUICI,PROTEGE PAR LE BREVET DE BASE,Y COMPRIS DES SELS PHARMACEUTIQUEMENT ACCEPTABLES
0593Netherlands► SubscribePRODUCT NAME: LINACLOTIDE; REGISTRATION NO/DATE: EU/1/12/801/001-004 20121126
201Luxembourg► SubscribePRODUCT NAME: LINACLOTIDE ET TOUTE FORME THERAPEUTIQUE EQUIVALENTE DE CELUICI,PROTETE PAR LE BREVET DE BASE,Y COMPRIS DES SELS PHARMACEUTIQUEMENT ACCEPTABLES
0594Netherlands► SubscribePRODUCT NAME: LINACLOTIDE; REGISTRATION NO/DATE: EU/1/12/801/001-004 20121126
6Finland► Subscribe
2013013Lithuania► SubscribePRODUCT NAME: LINACLOTIDUM; REGISTRATION NO/DATE: EU/1/12/801/001 - EU/1/12/801/004 20121126
2013 00026Denmark► Subscribe
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
00593Netherlands► SubscribePRODUCT NAME: LINACLOTIDE; REGISTRATION NO/DATE: EU/1/12/801/001-004 20121126
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Moodys
Dow
Chinese Patent Office
Medtronic
McKesson
Novartis
Healthtrust
Covington
Fuji
Federal Trade Commission

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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