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Serving leading biopharmaceutical companies globally:

QuintilesIMS
Cipla
Covington
Baxter
Cerilliant
McKesson
McKinsey
US Department of Justice
Julphar
Fuji

Generated: January 21, 2018

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-four patent family members in thirty-six countries.

There are ten drug master file entries for linaclotide. Three suppliers are listed for this compound.
Summary for linaclotide
Pharmacology for linaclotide

US Patents and Regulatory Information 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;ORAL 202811-001 Aug 30, 2012 RX Yes No ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Forest Labs Llc LINZESS linaclotide CAPSULE;ORAL 202811-002 Aug 30, 2012 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Forest Labs Llc LINZESS linaclotide CAPSULE;ORAL 202811-001 Aug 30, 2012 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Forest Labs Llc LINZESS linaclotide CAPSULE;ORAL 202811-003 Jan 25, 2017 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Forest Labs Llc LINZESS linaclotide CAPSULE;ORAL 202811-002 Aug 30, 2012 RX Yes Yes ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Forest Labs Llc LINZESS linaclotide CAPSULE;ORAL 202811-003 Jan 25, 2017 RX Yes No ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Forest Labs Llc LINZESS linaclotide CAPSULE;ORAL 202811-001 Aug 30, 2012 RX Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Forest Labs Llc LINZESS linaclotide CAPSULE;ORAL 202811-001 Aug 30, 2012 RX Yes No ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Forest Labs Llc LINZESS linaclotide CAPSULE;ORAL 202811-002 Aug 30, 2012 RX Yes Yes ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Forest Labs Llc LINZESS linaclotide CAPSULE;ORAL 202811-002 Aug 30, 2012 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Non-Orange Book US Patents for 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
7,772,188 Methods and compositions for the treatment of gastrointestinal disorders ➤ Subscribe
2,014,073,571 ➤ Subscribe
7,910,546 Methods and compositions for the treatment of gastrointestinal disorders ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for linaclotide

Supplementary Protection Certificates for linaclotide

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0594 Netherlands ➤ Subscribe PRODUCT NAME: LINACLOTIDE; REGISTRATION NO/DATE: EU/1/12/801/001-004 20121126
2013014 Lithuania ➤ Subscribe PRODUCT NAME: LINACLOTIDUM; REGISTRATION NO/DATE: EU/1/12/801/001 - EU/1/12/801/004 20121126
0593 Netherlands ➤ Subscribe PRODUCT NAME: LINACLOTIDE; REGISTRATION NO/DATE: EU/1/12/801/001-004 20121126
00594 Netherlands ➤ Subscribe PRODUCT NAME: LINACLOTIDE; REGISTRATION NO/DATE: EU/1/12/801/001-004 20121126
2013013 Lithuania ➤ Subscribe PRODUCT NAME: LINACLOTIDUM; REGISTRATION NO/DATE: EU/1/12/801/001 - EU/1/12/801/004 20121126
201 Luxembourg ➤ Subscribe PRODUCT NAME: LINACLOTIDE ET TOUTE FORME THERAPEUTIQUE EQUIVALENTE DE CELUICI,PROTETE PAR LE BREVET DE BASE,Y COMPRIS DES SELS PHARMACEUTIQUEMENT ACCEPTABLES
00593 Netherlands ➤ Subscribe PRODUCT NAME: LINACLOTIDE; REGISTRATION NO/DATE: EU/1/12/801/001-004 20121126
90024-6 Sweden ➤ Subscribe PRODUCT NAME: LINAKLOTID; REG. NO/DATE: EU/1/12/801/001 20121126
2013 00026 Denmark ➤ Subscribe
6 Finland ➤ Subscribe
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Express Scripts
Fish and Richardson
Dow
AstraZeneca
McKinsey
Novartis
US Army
McKesson

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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