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 nineteen patent family members in forty-four 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 2021 were $1.1bn, indicating a strong incentive for generic entry (peak sales were $1.5bn in 2020).
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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Summary for LINZESS
| International Patents: | 219 |
| US Patents: | 12 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 21 |
| Clinical Trials: | 19 |
| Patent Applications: | 273 |
| Drug Prices: | Drug price information for LINZESS |
| Drug Sales Revenues: | Drug sales revenues for LINZESS |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for LINZESS |
| What excipients (inactive ingredients) are in LINZESS? | LINZESS excipients list |
| DailyMed Link: | LINZESS at DailyMed |
Recent Clinical Trials for LINZESS
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| AbbVie | Phase 2 |
| National Cancer Institute (NCI) | Early Phase 1 |
| RenJi Hospital | Phase 4 |
Pharmacology for LINZESS
| Drug Class | Guanylate Cyclase-C Agonist |
| Mechanism of Action | Guanylate Cyclase Activators |
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Stable formulations of linaclotide
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Patented Use: METHOD OF TREATING CHRONIC IDIOPATHIC CONSTIPATION IN ADULT PATIENTS.
Stable formulations of linaclotide
Patent Number: ⤷ Sign Up
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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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING CHRONIC IDIOPATHIC CONSTIPATION IN ADULT PATIENTS.
Methods and compositions for the treatment of gastrointestinal disorders
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING IRRITABLE BOWEL SYNDROME WITH CONSTIPATION IN ADULTS
Methods and compositions for the treatment of gastrointestinal disorders
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Methods and compositions for the treatment of gastrointestinal disorders
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Patent Expiration: ⤷ Sign Up
Methods and compositions for the treatment of gastrointestinal disorders
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Patent Expiration: ⤷ Sign Up
Methods and compositions for the treatment of gastrointestinal disorders
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Methods and compositions for the treatment of gastrointestinal disorders
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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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING CHRONIC IDIOPATHIC CONSTIPATION IN ADULT PATIENTS.
Methods and compositions for the treatment of gastrointestinal disorders
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING IRRITABLE BOWEL SYNDROME WITH CONSTIPATION IN ADULTS
Formulations comprising linaclotide
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Patented Use: METHOD OF TREATING IRRITABLE BOWEL SYNDROME WITH CONSTIPATION IN ADULT PATIENTS.
Formulations comprising linaclotide
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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
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Treatments for gastrointestinal disorders
Patent Number: ⤷ Sign Up
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Patented Use: METHOD OF TREATING CHRONIC IDIOPATHIC CONSTIPATION IN ADULT PATIENTS.
Treatments for gastrointestinal disorders
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF FUNCTIONAL CONSTIPATION IN PEDIATRIC PATIENTS 6 TO 17 YEARS OF AGE
Treatments for gastrointestinal disorders
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Treatments for gastrointestinal disorders
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING CHRONIC IDIOPATHIC CONSTIPATION IN ADULT PATIENTS.
Treatments for gastrointestinal disorders
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF FUNCTIONAL CONSTIPATION IN PEDIATRIC PATIENTS 6 TO 17 YEARS OF AGE
Treatments for gastrointestinal disorders
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
| 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 | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Abbvie | LINZESS | linaclotide | CAPSULE;ORAL | 202811-002 | Aug 30, 2012 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Abbvie | LINZESS | linaclotide | CAPSULE;ORAL | 202811-001 | Aug 30, 2012 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Abbvie | LINZESS | linaclotide | CAPSULE;ORAL | 202811-002 | Aug 30, 2012 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Abbvie | LINZESS | linaclotide | CAPSULE;ORAL | 202811-001 | Aug 30, 2012 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Abbvie | LINZESS | linaclotide | CAPSULE;ORAL | 202811-003 | Jan 25, 2017 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Abbvie | LINZESS | linaclotide | CAPSULE;ORAL | 202811-001 | Aug 30, 2012 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| >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 | ⤷ Sign Up | ⤷ Sign Up |
| Abbvie | LINZESS | linaclotide | CAPSULE;ORAL | 202811-002 | Aug 30, 2012 | ⤷ Sign Up | ⤷ Sign Up |
| Abbvie | LINZESS | linaclotide | CAPSULE;ORAL | 202811-003 | Jan 25, 2017 | ⤷ Sign Up | ⤷ Sign Up |
| Abbvie | LINZESS | linaclotide | CAPSULE;ORAL | 202811-001 | Aug 30, 2012 | ⤷ Sign Up | ⤷ Sign Up |
| Abbvie | LINZESS | linaclotide | CAPSULE;ORAL | 202811-001 | Aug 30, 2012 | ⤷ Sign Up | ⤷ Sign Up |
| Abbvie | LINZESS | linaclotide | CAPSULE;ORAL | 202811-003 | Jan 25, 2017 | ⤷ Sign Up | ⤷ Sign Up |
| Abbvie | LINZESS | linaclotide | CAPSULE;ORAL | 202811-003 | Jan 25, 2017 | ⤷ Sign Up | ⤷ Sign Up |
| >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
Patent: TRAITEMENTS POUR DES TROUBLES GASTRO-INTESTINAUX (TREATMENTS FOR GASTROINTESTINAL DISORDERS)
Estimated Expiration: ⤷ Sign Up
China
Patent: 4053449
Patent: Treatments for gastrointestinal disorders
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 76055
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 76055
Patent: TRAITEMENTS POUR DES TROUBLES GASTRO-INTESTINAUX (TREATMENTS FOR GASTROINTESTINAL DISORDERS)
Estimated Expiration: ⤷ Sign Up
Hungary
Patent: 32237
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 12592
Estimated Expiration: ⤷ Sign Up
Patent: 14524444
Estimated Expiration: ⤷ Sign Up
Patent: 18002740
Patent: 消化器疾患の治療 (TREATMENT OF GASTROINTESTINAL DISORDERS)
Estimated Expiration: ⤷ Sign Up
Patent: 19085415
Patent: 消化器疾患の治療 (TREATMENT OF GASTROINTESTINAL DISORDERS)
Estimated Expiration: ⤷ Sign Up
Patent: 20128424
Patent: 消化器疾患の治療 (TREATMENTS FOR GASTROINTESTINAL DISORDERS)
Estimated Expiration: ⤷ Sign Up
Patent: 22010265
Patent: 消化器疾患の治療
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 7354
Patent: TRATAMIENTOS PARA TRASTORNOS GASTROINTESTINALES. (TREATMENTS FOR GASTROINTESTINAL DISORDERS.)
Estimated Expiration: ⤷ Sign Up
Patent: 14001798
Patent: TRATAMIENTOS PARA TRASTORNOS GASTROINTESTINALES. (TREATMENTS FOR GASTROINTESTINAL DISORDERS.)
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 76055
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 14864
Estimated Expiration: ⤷ Sign Up
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 |
|---|---|---|---|
| Eurasian Patent Organization | 201170337 | СТАБИЛЬНАЯ ТВЕРДАЯ КОМПОЗИЦИЯ ПОЛИПЕПТИДНОГО АГОНИСТА GC-C РЕЦЕПТОРА, ПРИЕМЛЕМАЯ ДЛЯ ПЕРОРАЛЬНОГО ВВЕДЕНИЯ | ⤷ Sign Up |
| Slovenia | 2246360 | ⤷ Sign Up | |
| China | 104053449 | Treatments for gastrointestinal disorders | ⤷ Sign Up |
| Austria | 477268 | ⤷ Sign Up | |
| Lithuania | C1594517 | ⤷ Sign Up | |
| Poland | 2603232 | ⤷ Sign Up | |
| Denmark | 1911763 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for LINZESS
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2246360 | 122013000045 | Germany | ⤷ Sign Up | 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 | SPC/GB13/032 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: LINACLOTIDE; REGISTERED: UK EU/1/12/801/001 20121128; UK EU/1/12/801/002 20121128; UK EU/1/12/801/003 20121128; UK EU/1/12/801/004 20121128 |
| 2246360 | 300594 | Netherlands | ⤷ Sign Up | PRODUCT NAME: LINACLOTIDE; REGISTRATION NO/DATE: EU/1/12/801/001-004 20121126 |
| 1594517 | 2013/023 | Ireland | ⤷ Sign Up | PRODUCT: LINACLOTIDE AND EVERY THERAPEUTICAL EQUIVALENT FORM THEREOF AS PROTECTED BY THE BASIC PATENT, INCLUDING PHARMACEUTICALLY ACCEPTABLE SALTS. REGISTRATION NO/DATE IRELAND EU/1/12/801/001, EU/1/12/801/002, EU/1/12/801/003, EU/1/12/801/004 / 26/11/2012 |
| 2246360 | 2013C/031 | Belgium | ⤷ Sign Up | PRODUCT NAME: LINACLOTIDE EN ZIJN FARMACEUTISCH AANVAARDBARE ZOUTEN; AUTHORISATION NUMBER AND DATE: EU/1/12/801/001 20121128 |
| 1594517 | 300593 | Netherlands | ⤷ Sign Up | PRODUCT NAME: LINACLOTIDE; REGISTRATION NO/DATE: EU/1/12/801/001-004 20121128 |
| 1594517 | 466 | Finland | ⤷ Sign Up | |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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.
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