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
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: | 357 |
Formulation / Manufacturing: | see details |
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 |
Anatomical Therapeutic Chemical (ATC) Classes 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
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Stable formulations of linaclotide
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Patented Use: METHOD OF TREATING CHRONIC IDIOPATHIC CONSTIPATION IN ADULT PATIENTS.
Stable formulations of linaclotide
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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
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Patented Use: METHOD OF TREATING CHRONIC IDIOPATHIC CONSTIPATION IN ADULT PATIENTS.
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
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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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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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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
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Patented Use: METHOD OF TREATING CHRONIC IDIOPATHIC CONSTIPATION IN ADULT PATIENTS.
Methods and compositions for the treatment of gastrointestinal disorders
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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
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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
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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 | ||||
>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 | 202811-001 | 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 |
Abbvie | LINZESS | linaclotide | CAPSULE;ORAL | 202811-002 | Aug 30, 2012 | ⤷ 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
Estimated Expiration: ⤷ Sign Up
China
Patent: 4053449
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 76055
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 76055
Estimated Expiration: ⤷ Sign Up
Hungary
Patent: 32237
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Japan
Patent: 12592
Estimated Expiration: ⤷ Sign Up
Patent: 14524444
Estimated Expiration: ⤷ Sign Up
Patent: 18002740
Estimated Expiration: ⤷ Sign Up
Patent: 19085415
Estimated Expiration: ⤷ Sign Up
Patent: 20128424
Estimated Expiration: ⤷ Sign Up
Patent: 22010265
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 7354
Estimated Expiration: ⤷ Sign Up
Patent: 14001798
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 76055
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 14864
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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 |
---|---|---|---|
European Patent Office | 1730172 | METHODES ET COMPOSITIONS POUR LE TRAITEMENT DE TROUBLES GASTRO-INTESTINAUX (METHODS AND COMPOSITIONS FOR THE TREATMENT OF GASTROINTESTINAL DISORDERS) | ⤷ Sign Up |
Hong Kong | 1161978 | 適合口服給藥的鳥苷酸環化酶- 受體激動劑多肽的穩定的固體製劑 (STABLE SOLID FORMULATION OF A GC-C RECEPTOR AGONIST POLYPEPTIDE SUITABLE FOR ORAL ADMINISTRATION -C) | ⤷ Sign Up |
Japan | 4584911 | ⤷ Sign Up | |
Mexico | 2020005326 | FORMULACIONES QUE CONTIENEN LINACLOTIDA PARA ADMINISTRACION ORAL. (LINACLOTIDE-CONTAINING FORMULATIONS FOR ORAL ADMINISTRATION.) | ⤷ 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 | 92200 | Luxembourg | ⤷ Sign Up | 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 | CA 2013 00026 | Denmark | ⤷ Sign Up | |
2246360 | 23/2013 | Austria | ⤷ Sign Up | PRODUCT NAME: LINACLOTID UND PHARMAZEUTISCH ANNEHMBARE SALZE HIERVON; REGISTRATION NO/DATE: EU/1/12/801/001-004 (MITTEILUNG) 20121128 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |