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Last Updated: April 15, 2024

Linaclotide - Generic Drug Details


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What are the generic drug sources for linaclotide and what is the scope of freedom to operate?

Linaclotide is the generic ingredient in two branded drugs marketed by Aurobindo Pharma, Mylan, and Abbvie, and is included in three NDAs. There are twelve patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Linaclotide has two hundred and eighteen patent family members in forty-four countries.

There are ten drug master file entries for linaclotide. One supplier is listed for this compound. There is one tentative approval for this compound.

Recent Clinical Trials for linaclotide

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

SponsorPhase
AbbViePhase 2
AbbViePhase 3
Zhiguo LiuN/A

See all linaclotide clinical trials

Generic filers with tentative approvals for LINACLOTIDE
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial72MCGCAPSULE;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for linaclotide
Paragraph IV (Patent) Challenges for LINACLOTIDE
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 linaclotide

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 202811-003 Jan 25, 2017 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Abbvie LINZESS linaclotide CAPSULE;ORAL 202811-001 Aug 30, 2012 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Abbvie LINZESS linaclotide CAPSULE;ORAL 202811-001 Aug 30, 2012 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Abbvie LINZESS linaclotide CAPSULE;ORAL 202811-003 Jan 25, 2017 RX Yes Yes ⤷  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 ⤷  Try a Trial
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 202811-001 Aug 30, 2012 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial 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 linaclotide

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
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
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 202811-001 Aug 30, 2012 ⤷  Try a Trial ⤷  Try a Trial
Abbvie LINZESS linaclotide CAPSULE;ORAL 202811-001 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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for linaclotide

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 linaclotide

Country Patent Number Title Estimated Expiration
Hungary S1300022 ⤷  Try a Trial
Spain 2763404 ⤷  Try a Trial
Poland 2328601 ⤷  Try a Trial
Hungary E046922 ⤷  Try a Trial
Canada 2770077 FORMULATIONS COMPRENANT DU LINACLOTIDE (FORMULATIONS COMPRISING LINACLOTIDE) ⤷  Try a Trial
Serbia 59978 STABILNE FORMULACIJE LINAKLOTIDA (STABLE FORMULATIONS OF LINACLOTIDE) ⤷  Try a Trial
Mexico 348823 FORMULACIONES ESTABLES DE LINACLOTIDA. (STABLE FORMULATIONS OF LINACLOTIDE.) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for linaclotide

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2246360 300594 Netherlands ⤷  Try a Trial PRODUCT NAME: LINACLOTIDE; REGISTRATION NO/DATE: EU/1/12/801/001-004 20121126
1594517 2013/023 Ireland ⤷  Try a Trial 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
1594517 PA2013013,C1594517 Lithuania ⤷  Try a Trial PRODUCT NAME: LINAKLOTIDAS; REGISTRATION NO/DATE: EU/1/12/801/001 - EU/1/12/801/004 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
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 132013902159410 Italy ⤷  Try a Trial PRODUCT NAME: LINACLOTIDE(CONSTELLA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/12/801/001-2-3-4, 20121128
2246360 122013000045 Germany ⤷  Try a Trial 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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