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Last Updated: January 18, 2020

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Linaclotide - Generic Drug Details

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

Linaclotide is the generic ingredient in one branded drug marketed by Allergan and is included in one NDA. There are ten patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Linaclotide has one hundred and sixty-one patent family members in thirty-eight countries.

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

Recent Clinical Trials for linaclotide

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

SponsorPhase
AllerganPhase 2
AllerganPhase 3
United States Department of DefensePhase 2

See all linaclotide clinical trials

Recent Litigation for linaclotide

Identify potential future generic entrants

District Court Litigation
Case NameDate
Forest Laboratories Holdings, Ltd. v. Mylan Pharmaceuticals Inc.2018-12-19
Forest Laboratories Holdings, Ltd. v. Mylan Pharmaceuticals Inc.2018-03-29
Forest Laboratories Holdings, Ltd. v. Teva Pharmaceuticals USA, Inc.2018-02-02

See all linaclotide litigation

Pharmacology for linaclotide
Synonyms for linaclotide
((3S,6R,9S,15R,20R,23S,26S,29R,32R,37R,40S,45aS)-32-amino-40-(2-amino-2-oxoethyl)-26-(2-carboxyethyl)-23-(4-hydroxybenzyl)-9-((R)-1-hydroxyethyl)-3-methyl-1,4,7,10,13,22,25,28,31,3
8,41,47-dodecaoxotetracontahydro-19H-37,20-(epiminomethano)-6,29-(methanodithiomethano)pyrrolo[2,1-s][1,2,27,28]tetrathia[5,8,11,14,17,20,23,32,35,38,41]undecaazacyclotritetracontine-15-carbonyl)-L-ty
851199-59-2
ASP 0456
CHEBI:68551
CHEMBL3301675
Constella (TN)
CS-3577
Cys Cys Glu Tyr Cys Cys Asn Pro Ala Cys Thr Gly Cys Tyr (disulfide bridge: 1-6; 2-10; 5-13)
D09355
DB08890
DTXSID90234256
H-Cys(1)-Cys(2)-Glu-Tyr-Cys(3)-Cys(1)-Asn-Pro-Ala-Cys(2)-Thr-Gly-Cys(3)-Tyr-OH
HSDB 8224
HY-17584
L-cysteinyl-L-cysteinyl-L-alpha-glutamyl-L-tyrosyl-L-cysteinyl-L-cysteinyl-L-asparaginyl-L-prolyl-L-alanyl-L-cysteinyl-L-threonylglycyl-L-cysteinyl-L-tyrosine cyclic (1->6),(2->10),(5->13)-tris(disulfide)
L-Tyrosine, L-cysteinyl-L-cysteinyl-L-alpha-glutamyl-L-tyrosyl-L-cysteinyl-L-cysteinyl-L-asparaginyl-L-prolyl-L-alanyl-L-cysteinyl-L-threonylglycyl-L-cysteinyl-, cyclic (1->6),(2->10),(5->13)-tris(disulfide)
Linaclotide (JAN/USAN)
Linaclotide [USAN:INN]
Linzess
Linzess (TN)
rosine
SCHEMBL13114620
Paragraph IV (Patent) Challenges for LINACLOTIDE
Tradename Dosage Ingredient NDA Submissiondate
LINZESS CAPSULE;ORAL linaclotide 202811 2017-11-07
LINZESS CAPSULE;ORAL linaclotide 202811 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
Allergan LINZESS linaclotide CAPSULE;ORAL 202811-002 Aug 30, 2012 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
Allergan LINZESS linaclotide CAPSULE;ORAL 202811-002 Aug 30, 2012 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
Allergan LINZESS linaclotide CAPSULE;ORAL 202811-002 Aug 30, 2012 RX Yes No   Start Trial   Start Trial Y   Start Trial
Allergan LINZESS linaclotide CAPSULE;ORAL 202811-001 Aug 30, 2012 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for linaclotide

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2246360 122013000045 Germany   Start 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
1594517 C01594517/01 Switzerland   Start Trial PRODUCT NAME: LINACLOTID; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 62684 20.06.2013
1594517 2013C/032 Belgium   Start Trial PRODUCT NAME: LINACLOTIDE EN ELKE THERAPEUTISCH EQUIVALENTE VORM DAARVAN ALS BESCHERMD DOOR HET BASISOCTROOI, WAARONDER FARMACEUTISCH AANVAARDBARE ZOUTEN; AUTHORISATION NUMBER AND DATE: EU/1/12/801/001 20121128
1594517 CA 2013 00026 Denmark   Start Trial
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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Merck
McKinsey
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Harvard Business School

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 verifification 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.