Remove trial restrictions ▶ Start for $1

Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Dow
Merck
Moodys
McKinsey
Medtronic

Last Updated: August 11, 2022

LINZESS Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard

▶ Start for $1
Remove trial restrictions


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 two hundred and three 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 2019 were $934mm indicating the motivation for generic entry (peak sales were $1.5bn in 2018).

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

< Available with Subscription >

  Try it Free

Drug patent expirations by year for LINZESS
Drug Prices for LINZESS

See drug prices for LINZESS

Drug Sales Revenue Trends for LINZESS

See drug sales revenues for LINZESS

Recent Clinical Trials for LINZESS

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

SponsorPhase
National Cancer Institute (NCI)Early Phase 1
RenJi HospitalPhase 4
Jiangsu Hansoh Pharmaceutical Co., Ltd.Phase 3

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 seventeen US patents.

Patents protecting LINZESS

Stable formulations of linaclotide
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Stable formulations of linaclotide
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING CHRONIC IDIOPATHIC CONSTIPATION IN ADULT PATIENTS.

Methods and compositions for the treatment of gastrointestinal disorders
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING CHRONIC IDIOPATHIC CONSTIPATION IN ADULT PATIENTS.

Methods and compositions for the treatment of gastrointestinal disorders
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING IRRITABLE BOWEL SYNDROME WITH CONSTIPATION IN ADULTS

Methods and compositions for the treatment of gastrointestinal disorders
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Methods and compositions for the treatment of gastrointestinal disorders
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Methods and compositions for the treatment of gastrointestinal disorders
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Methods and compositions for the treatment of gastrointestinal disorders
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Methods and compositions for the treatment of gastrointestinal disorders
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING CHRONIC IDIOPATHIC CONSTIPATION IN ADULT PATIENTS.

Methods and compositions for the treatment of gastrointestinal disorders
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING IRRITABLE BOWEL SYNDROME WITH CONSTIPATION IN ADULTS

Formulations comprising linaclotide
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING CHRONIC IDIOPATHIC CONSTIPATION IN ADULT PATIENTS.

Formulations comprising linaclotide
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING IRRITABLE BOWEL SYNDROME WITH CONSTIPATION IN ADULT PATIENTS.

Stable solid formulation of a GC-C receptor agonist polypeptide suitable for oral administration
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Treatments for gastrointestinal disorders
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING CHRONIC IDIOPATHIC CONSTIPATION IN ADULT PATIENTS.

Treatments for gastrointestinal disorders
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Treatments for gastrointestinal disorders
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING CHRONIC IDIOPATHIC CONSTIPATION IN ADULT PATIENTS.

Treatments for gastrointestinal disorders
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: METHOD OF TREATING IRRITABLE BOWEL SYNDROME WITH CONSTIPATION IN ADULT PATIENTS.

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 See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Allergan LINZESS linaclotide CAPSULE;ORAL 202811-002 Aug 30, 2012 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Allergan LINZESS linaclotide CAPSULE;ORAL 202811-002 Aug 30, 2012 RX Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Allergan LINZESS linaclotide CAPSULE;ORAL 202811-003 Jan 25, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Allergan LINZESS linaclotide CAPSULE;ORAL 202811-001 Aug 30, 2012 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Allergan LINZESS linaclotide CAPSULE;ORAL 202811-002 Aug 30, 2012 RX Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity 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: See Plans and Pricing

China

Patent: 4053449
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 76055
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 76055
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 32237
Estimated Expiration: See Plans and Pricing

Japan

Patent: 12592
Estimated Expiration: See Plans and Pricing

Patent: 14524444
Estimated Expiration: See Plans and Pricing

Patent: 18002740
Estimated Expiration: See Plans and Pricing

Patent: 19085415
Estimated Expiration: See Plans and Pricing

Patent: 20128424
Estimated Expiration: See Plans and Pricing

Patent: 22010265
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 7354
Estimated Expiration: See Plans and Pricing

Patent: 14001798
Estimated Expiration: See Plans and Pricing

Poland

Patent: 76055
Estimated Expiration: See Plans and Pricing

Spain

Patent: 14864
Estimated Expiration: See Plans and Pricing

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
Australia 2005222387 Methods and compositions for the treatment of gastrointestinal disorders See Plans and Pricing
Japan 5748791 See Plans and Pricing
Israel 177772 See Plans and Pricing
Mexico 2013001677 FORMULACIONES ESTABLES DE LINACLOTIDA. (STABLE FORMULATIONS OF LINACLOTIDE.) See Plans and Pricing
Germany 602004007105 See Plans and Pricing
Japan 2006516631 See Plans and Pricing
>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 See Plans and Pricing 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
2246360 122013000045 Germany See Plans and Pricing 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
2246360 C300594 Netherlands See Plans and Pricing PRODUCT NAME: LINACLOTIDE; REGISTRATION NO/DATE: EU/1/12/801/001-004 20121126
1594517 SPC/GB13/032 United Kingdom See Plans and Pricing PRODUCT NAME: LINACLOTIDE; REGISTERED: UK EU/1/12/801/001 20121126; UK EU/1/12/801/002 20121126; UK EU/1/12/801/003 20121126; UK EU/1/12/801/004 20121126
1594517 24/2013 Austria See Plans and Pricing PRODUCT NAME: LINACLOTID UND PHARMAZEUTISCH ANNEHMBAREN SALZE HIERVON; REGISTRATION NO/DATE: EU/1/12/801/001-004 (MITTEILUNG) 20121128
2246360 92201 Luxembourg See Plans and Pricing PRODUCT NAME: LINACLOTIDE ET TOUTE FORME THERAPEUTIQUE EQUIVALENTE DE CELUI-CI, PROTETE PAR LE BREVET DE BASE, Y COMPRIS DES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/12/801/001-004 20121126
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Medtronic
Dow
Express Scripts
Moodys
Baxter
Mallinckrodt

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 verification 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.