Get our Free Patent Expiration Newsletter

Serving leading biopharmaceutical companies globally:

McKinsey
Boehringer Ingelheim
Johnson and Johnson
Colorcon
Medtronic
Express Scripts

Last Updated: October 18, 2019

DrugPatentWatch Database Preview

Linaclotide - Generic Drug Details

See Plans and Pricing

« Back to Dashboard

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

Linaclotide is the generic ingredient in one branded drug marketed by Allergan Sales Llc 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 fifty-eight 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 3
United States Department of DefensePhase 2
Sidney Kimmel Cancer Center at Thomas Jefferson UniversityPhase 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

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 Sales Llc LINZESS linaclotide CAPSULE;ORAL 202811-001 Aug 30, 2012 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Allergan Sales Llc LINZESS linaclotide CAPSULE;ORAL 202811-003 Jan 25, 2017 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Allergan Sales Llc LINZESS linaclotide CAPSULE;ORAL 202811-002 Aug 30, 2012 RX Yes No   Start Trial   Start Trial Y   Start Trial
Allergan Sales Llc LINZESS linaclotide CAPSULE;ORAL 202811-001 Aug 30, 2012 RX Yes Yes   Start Trial   Start Trial   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 92201 Luxembourg   Start Trial PRODUCT NAME: LINACLOTIDE ET TOUTE FORME THERAPEUTIQUE EQUIVALENTE DE CELUICI,PROTETE PAR LE BREVET DE BASE,Y COMPRIS DES SELS PHARMACEUTIQUEMENT ACCEPTABLES
2246360 CA 2013 00027 Denmark   Start Trial
1594517 2013/023 Ireland   Start Trial PRODUCT: LINACLOTIDE; MARKET AUTHORISATION: IRELAND EU/1/12/801/001, EU/1/12/801/002, EU/1/12/801/003, EU/1/12/801/004, 26/11/2012 EUROPEAN UNION EU/1/12/801/001, EU/1/12/801/002, EU/1/12/801/003, EU/1/12/801/004, 26/11/2012
1594517 24/2013 Austria   Start Trial PRODUCT NAME: LINACLOTID UND PHARMAZEUTISCH ANNEHMBAREN SALZE HIERVON; REGISTRATION NO/DATE: EU/1/12/801/001-004 (MITTEILUNG) 20121128
>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:

AstraZeneca
Express Scripts
Moodys
Baxter
McKinsey
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.