.

Deeper Knowledge, Faster

  • Analyze global market entry opportunities
  • Uncover prior art in expired and abandoned patents
  • Obtain formulation and manufacturing information

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving leading biopharmaceutical companies globally:

Teva
Baxter
Queensland Health
Cerilliant
Johnson and Johnson
Fish and Richardson
Chubb
Julphar
Daiichi Sankyo
Medtronic

Generated: December 14, 2017

DrugPatentWatch Database Preview

LINZESS Drug Profile

« Back to Dashboard

When do Linzess patents expire, 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 ten patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and forty-seven patent family members in thirty-six countries and thirteen supplementary protection certificates in seven 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.

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Forest Labs LlcLINZESSlinaclotideCAPSULE;ORAL202811-002Aug 30, 2012RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Forest Labs LlcLINZESSlinaclotideCAPSULE;ORAL202811-002Aug 30, 2012RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Forest Labs LlcLINZESSlinaclotideCAPSULE;ORAL202811-002Aug 30, 2012RXYesYes► Subscribe► Subscribe► SubscribeYY► Subscribe
Forest Labs LlcLINZESSlinaclotideCAPSULE;ORAL202811-003Jan 25, 2017RXYesNo► Subscribe► Subscribe► SubscribeYY► Subscribe
Forest Labs LlcLINZESSlinaclotideCAPSULE;ORAL202811-001Aug 30, 2012RXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Forest Labs LlcLINZESSlinaclotideCAPSULE;ORAL202811-003Jan 25, 2017RXYesNo► Subscribe► Subscribe► SubscribeYY► Subscribe
Forest Labs LlcLINZESSlinaclotideCAPSULE;ORAL202811-002Aug 30, 2012RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Forest Labs LlcLINZESSlinaclotideCAPSULE;ORAL202811-003Jan 25, 2017RXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Forest Labs LlcLINZESSlinaclotideCAPSULE;ORAL202811-001Aug 30, 2012RXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Forest Labs LlcLINZESSlinaclotideCAPSULE;ORAL202811-003Jan 25, 2017RXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Paragraph IV (Patent) Challenges 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
This preview shows a limited data set
Subscribe for full access, or try a Trial

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.

Export unavailable in trial.
Subscribe for complete access.

International Patent Family for Tradename: LINZESS

Country Document Number Estimated Expiration
Russian Federation2543350► Subscribe
Argentina073075► Subscribe
Singapore153824► Subscribe
Norway20053864► Subscribe
China101787073► Subscribe
Colombia6351746► Subscribe
Ukraine108636► Subscribe
Mexico2011001620► Subscribe
SloveniaEP2246360► Subscribe
Denmark2536742► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

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.

Export unavailable in trial.
Subscribe for complete access.

Supplementary Protection Certificates for Tradename: LINZESS

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0594Netherlands► SubscribePRODUCT NAME: LINACLOTIDE; REGISTRATION NO/DATE: EU/1/12/801/001-004 20121126
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 00026Denmark► Subscribe
2013013Lithuania► SubscribePRODUCT NAME: LINACLOTIDUM; REGISTRATION NO/DATE: EU/1/12/801/001 - EU/1/12/801/004 20121126
2013 00027Denmark► Subscribe
00594Netherlands► SubscribePRODUCT NAME: LINACLOTIDE; REGISTRATION NO/DATE: EU/1/12/801/001-004 20121126
200Luxembourg► SubscribePRODUCT NAME: LINACLOTIDE ET TOUTE FORME THERAPEUTIQUE EQUIVALENTE DE CELUICI,PROTEGE PAR LE BREVET DE BASE,Y COMPRIS DES SELS PHARMACEUTIQUEMENT ACCEPTABLES
90024-6Sweden► SubscribePRODUCT NAME: LINAKLOTID; REG. NO/DATE: EU/1/12/801/001 20121126
2013014Lithuania► SubscribePRODUCT NAME: LINACLOTIDUM; REGISTRATION NO/DATE: EU/1/12/801/001 - EU/1/12/801/004 20121126
00593Netherlands► SubscribePRODUCT NAME: LINACLOTIDE; REGISTRATION NO/DATE: EU/1/12/801/001-004 20121126
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

« Back to Dashboard

For more information try a trial or see the plans and pricing

Serving leading biopharmaceutical companies globally:

Colorcon
Cantor Fitzgerald
Covington
Baxter
Citi
Teva
Fish and Richardson
Chubb
Harvard Business School
Julphar

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.

Copyright 2002-2017 thinkBiotech LLC
ISSN: 2162-2639

Secure SSL Encrypted
Privacy and Cookies
Terms & Conditions

Follow DrugPatentWatch:

botpot