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Johnson and Johnson
Boehringer Ingelheim

Last Updated: October 30, 2020

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Linaclotide - Generic Drug Details

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

Linaclotide is the generic ingredient in one branded drug marketed by Allergan and is included in one NDA. There are twelve 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 ninety-one patent family members in forty-one countries.

There are ten drug master file entries for linaclotide. One supplier is listed for this compound.

Recent Clinical Trials for linaclotide

Identify potential brand extensions & 505(b)(2) entrants

AllerganPhase 2
AllerganPhase 3
Sidney Kimmel Cancer Center at Thomas Jefferson UniversityPhase 2

See all linaclotide clinical trials

Pharmacology for linaclotide
Paragraph IV (Patent) Challenges for LINACLOTIDE
Tradename Dosage Ingredient NDA Submissiondate
LINZESS CAPSULE;ORAL linaclotide 202811 2017-11-07
LINZESS CAPSULE;ORAL linaclotide 202811 2016-08-30

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
Allergan LINZESS linaclotide CAPSULE;ORAL 202811-001 Aug 30, 2012 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Allergan LINZESS linaclotide CAPSULE;ORAL 202811-001 Aug 30, 2012 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Allergan LINZESS linaclotide CAPSULE;ORAL 202811-003 Jan 25, 2017 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for linaclotide

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1594517 5012-2013 Slovakia   Start Trial PRODUCT NAME: LINACLOTIDUM; REGISTRATION NO/DATE: EU/1/12/801/001 - EU/1/12/801/004 20121126
1594517 C01594517/01 Switzerland   Start Trial PRODUCT NAME: LINACLOTID; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 62684 20.06.2013
1594517 CA 2013 00026 Denmark   Start Trial
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim

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