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Last Updated: June 13, 2021

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LINZESS Drug Profile


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Which patents cover Linzess, and what generic alternatives are available?

Linzess is a drug marketed by Allergan and is included in one NDA. There are twelve patents protecting this drug and two Paragraph IV challenges.

This drug has one hundred and ninety-seven patent family members in forty-two countries.

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

DrugPatentWatch® Generic Entry Outlook for Linzess

Linzess was eligible for patent challenges on August 30, 2016.

Annual sales in 2018 were $1.5bn, indicating a strong incentive for generic entry.

There have been eleven patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for LINZESS
Drug Prices for LINZESS

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Drug Sales Revenue Trends for LINZESS

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Recent Clinical Trials for LINZESS

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

SponsorPhase
Jiangsu Hansoh Pharmaceutical Co., Ltd.Phase 3
United States Department of DefensePhase 2
Sidney Kimmel Cancer Center at Thomas Jefferson UniversityPhase 2

See all LINZESS clinical trials

Pharmacology for LINZESS
Paragraph IV (Patent) Challenges for LINZESS
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 LINZESS

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 202811-002 Aug 30, 2012 RX Yes No   Get Started Free   Get Started Free Y   Get Started Free
Allergan LINZESS linaclotide CAPSULE;ORAL 202811-002 Aug 30, 2012 RX Yes No   Get Started Free   Get Started Free   Get Started Free
Allergan LINZESS linaclotide CAPSULE;ORAL 202811-002 Aug 30, 2012 RX Yes No   Get Started Free   Get Started Free Y   Get Started Free
Allergan LINZESS linaclotide CAPSULE;ORAL 202811-003 Jan 25, 2017 RX Yes Yes   Get Started Free   Get Started Free   Get Started Free
>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 LINZESS

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1594517 1390024-6 Sweden   Get Started Free PRODUCT NAME: LINAKLOTID; REG. NO/DATE: EU/1/12/801/001 20121126
1594517 24/2013 Austria   Get Started Free PRODUCT NAME: LINACLOTID UND PHARMAZEUTISCH ANNEHMBAREN SALZE HIERVON; REGISTRATION NO/DATE: EU/1/12/801/001-004 (MITTEILUNG) 20121128
2246360 122013000045 Germany   Get Started Free PRODUCT 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
1594517 2013C/032 Belgium   Get Started Free PRODUCT NAME: LINACLOTIDE EN ELKE THERAPEUTISCH EQUIVALENTE VORM DAARVAN ALS BESCHERMD DOOR HET BASISOCTROOI, WAARONDER FARMACEUTISCH AANVAARDBARE ZOUTEN; AUTHORISATION NUMBER AND DATE: EU/1/12/801/001 20121128
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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