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Last Updated: February 23, 2024

LINZESS Drug Patent Profile


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

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

This drug has two hundred and fourteen patent family members in forty-three 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.

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.

There is one tentative approval for the generic drug (linaclotide), which indicates the potential for near-term generic launch.

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
AbbViePhase 2
National Cancer Institute (NCI)Early Phase 1
RenJi HospitalPhase 4

See all LINZESS clinical trials

Pharmacology for LINZESS
Paragraph IV (Patent) Challenges for LINZESS
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
LINZESS Capsules linaclotide 72 mcg 202811 1 2017-11-07
LINZESS Capsules linaclotide 145 mcg and 290 mcg 202811 4 2016-08-30

US Patents and Regulatory Information for LINZESS

LINZESS is protected by twenty-two US patents and one FDA Regulatory Exclusivity.

Patents protecting LINZESS

Stable formulations of linaclotide
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Stable formulations of linaclotide
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF TREATING CHRONIC IDIOPATHIC CONSTIPATION IN ADULT PATIENTS.

Stable formulations of linaclotide
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF FUNCTIONAL CONSTIPATION IN PEDIATRIC PATIENTS 6 TO 17 YEARS OF AGE

Methods and compositions for the treatment of gastrointestinal disorders
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF TREATING CHRONIC IDIOPATHIC CONSTIPATION IN ADULT PATIENTS.

Methods and compositions for the treatment of gastrointestinal disorders
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF FUNCTIONAL CONSTIPATION IN PEDIATRIC PATIENTS 6 TO 17 YEARS OF AGE

Methods and compositions for the treatment of gastrointestinal disorders
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF TREATING IRRITABLE BOWEL SYNDROME WITH CONSTIPATION IN ADULTS

Methods and compositions for the treatment of gastrointestinal disorders
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Methods and compositions for the treatment of gastrointestinal disorders
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Methods and compositions for the treatment of gastrointestinal disorders
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Methods and compositions for the treatment of gastrointestinal disorders
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Methods and compositions for the treatment of gastrointestinal disorders
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF FUNCTIONAL CONSTIPATION IN PEDIATRIC PATIENTS 6 TO 17 YEARS OF AGE

Methods and compositions for the treatment of gastrointestinal disorders
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF TREATING CHRONIC IDIOPATHIC CONSTIPATION IN ADULT PATIENTS.

Methods and compositions for the treatment of gastrointestinal disorders
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF TREATING IRRITABLE BOWEL SYNDROME WITH CONSTIPATION IN ADULTS

Formulations comprising linaclotide
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF TREATING IRRITABLE BOWEL SYNDROME WITH CONSTIPATION IN ADULT PATIENTS.

Formulations comprising linaclotide
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF TREATING CHRONIC IDIOPATHIC CONSTIPATION IN ADULT PATIENTS.

Stable solid formulation of a GC-C receptor agonist polypeptide suitable for oral administration
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Treatments for gastrointestinal disorders
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF TREATING CHRONIC IDIOPATHIC CONSTIPATION IN ADULT PATIENTS.

Treatments for gastrointestinal disorders
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF FUNCTIONAL CONSTIPATION IN PEDIATRIC PATIENTS 6 TO 17 YEARS OF AGE

Treatments for gastrointestinal disorders
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Treatments for gastrointestinal disorders
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF TREATING CHRONIC IDIOPATHIC CONSTIPATION IN ADULT PATIENTS.

Treatments for gastrointestinal disorders
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF FUNCTIONAL CONSTIPATION IN PEDIATRIC PATIENTS 6 TO 17 YEARS OF AGE

Treatments for gastrointestinal disorders
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: METHOD OF TREATING IRRITABLE BOWEL SYNDROME WITH CONSTIPATION IN ADULT PATIENTS.

FDA Regulatory Exclusivity protecting LINZESS

TREATMENT OF FUNCTIONAL CONSTIPATION IN PEDIATRIC PATIENTS 6 TO 17 YEARS OF AGE
Exclusivity Expiration: ⤷  Try a Trial

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Abbvie LINZESS linaclotide CAPSULE;ORAL 202811-002 Aug 30, 2012 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Abbvie LINZESS linaclotide CAPSULE;ORAL 202811-002 Aug 30, 2012 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Abbvie LINZESS linaclotide CAPSULE;ORAL 202811-001 Aug 30, 2012 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for LINZESS

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Abbvie LINZESS linaclotide CAPSULE;ORAL 202811-002 Aug 30, 2012 ⤷  Try a Trial ⤷  Try a Trial
Abbvie LINZESS linaclotide CAPSULE;ORAL 202811-003 Jan 25, 2017 ⤷  Try a Trial ⤷  Try a Trial
Abbvie LINZESS linaclotide CAPSULE;ORAL 202811-003 Jan 25, 2017 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for LINZESS

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
AbbVie Deutschland GmbH & Co. KG Constella linaclotide EMEA/H/C/002490
Constella is indicated for the symptomatic treatment of moderate to severe irritable-bowel syndrome with constipation (IBS-C) in adults.
Authorised no no no 2012-11-26
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for LINZESS

When does loss-of-exclusivity occur for LINZESS?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Canada

Patent: 46230
Estimated Expiration: ⤷  Try a Trial

China

Patent: 4053449
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 76055
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 76055
Estimated Expiration: ⤷  Try a Trial

Hungary

Patent: 32237
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 12592
Estimated Expiration: ⤷  Try a Trial

Patent: 14524444
Estimated Expiration: ⤷  Try a Trial

Patent: 18002740
Estimated Expiration: ⤷  Try a Trial

Patent: 19085415
Estimated Expiration: ⤷  Try a Trial

Patent: 20128424
Estimated Expiration: ⤷  Try a Trial

Patent: 22010265
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 7354
Estimated Expiration: ⤷  Try a Trial

Patent: 14001798
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 76055
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 14864
Estimated Expiration: ⤷  Try a Trial

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering LINZESS around the world.

Country Patent Number Title Estimated Expiration
Germany 602004028678 ⤷  Try a Trial
Mexico 347354 TRATAMIENTOS PARA TRASTORNOS GASTROINTESTINALES. (TREATMENTS FOR GASTROINTESTINAL DISORDERS.) ⤷  Try a Trial
South Korea 20230025926 경구 투여를 위한 리나클로타이드-함유 제형 (- LINACLOTIDE-CONTAINING FORMULATIONS FOR ORAL ADMINISTRATION) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for LINZESS

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1594517 92200 Luxembourg ⤷  Try a Trial PRODUCT NAME: LINACLOTIDE ET TOUTE FORME THERAPEUTIQUE EQUIVALENTE DE CELUI-CI, PROTEGE PAR LE BREVET DE BASE, Y COMPRIS DES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/12/801/001-004 20121126
1594517 5012-2013 Slovakia ⤷  Try a Trial PRODUCT NAME: LINACLOTIDUM; REGISTRATION NO/DATE: EU/1/12/801/001 - EU/1/12/801/004 20121126
2246360 2013C/031 Belgium ⤷  Try a Trial PRODUCT NAME: LINACLOTIDE EN ZIJN 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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Serving leading biopharmaceutical companies globally:

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Dow
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