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Last Updated: January 28, 2020

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LINZESS Drug Profile

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When do Linzess patents expire, and when can generic versions of Linzess launch?

Linzess is a drug marketed by Allergan and is included in one NDA. There are ten patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and sixty-one patent family members in thirty-eight 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.

US ANDA Litigation and Generic Entry Outlook for Linzess

Linzess was eligible for patent challenges on August 30, 2016.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 16, 2033. This may change due to patent challenges or generic licensing.

Annual sales in 2017 were $727mm indicating the motivation for generic entry.

There have been nine 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.

Indicators of Generic Entry

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Drug patent expirations by year for LINZESS
Drug Prices for LINZESS

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Drug Sales Revenue Trends for LINZESS

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Generic Entry Opportunity Date for LINZESS
Generic Entry Date for LINZESS*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
CAPSULE;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for LINZESS

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

SponsorPhase
United States Department of DefensePhase 2
Sidney Kimmel Cancer Center at Thomas Jefferson UniversityPhase 2
Ironwood Pharmaceuticals, Inc.Phase 3

See all LINZESS clinical trials

Recent Litigation for LINZESS

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 LINZESS litigation

Pharmacology for LINZESS
Synonyms for LINZESS
((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)
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
HSDB 8224
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
Linaclotide (JAN/USAN)
Linaclotide [USAN:INN]
Linzess (TN)
rosine
SCHEMBL13114620
Paragraph IV (Patent) Challenges for LINZESS
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 LINZESS

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   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 202811-002 Aug 30, 2012 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
Allergan LINZESS linaclotide CAPSULE;ORAL 202811-003 Jan 25, 2017 RX Yes Yes   Start Trial   Start Trial   Start Trial
Allergan LINZESS linaclotide CAPSULE;ORAL 202811-001 Aug 30, 2012 RX Yes Yes   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
>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 LINZESS

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1594517 C01594517/01 Switzerland   Start Trial PRODUCT NAME: LINACLOTID; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 62684 20.06.2013
1594517 92200 Luxembourg   Start Trial PRODUCT NAME: LINACLOTIDE ET TOUTE FORME THERAPEUTIQUE EQUIVALENTE DE CELUICI,PROTEGE PAR LE BREVET DE BASE,Y COMPRIS DES SELS PHARMACEUTIQUEMENT ACCEPTABLES
1594517 CA 2013 00026 Denmark   Start Trial
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 1390024-6 Sweden   Start Trial PRODUCT NAME: LINAKLOTID; REG. NO/DATE: EU/1/12/801/001 20121126
1594517 C300593 Netherlands   Start Trial PRODUCT NAME: LINACLOTIDE; 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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Serving leading biopharmaceutical companies globally:

Colorcon
Express Scripts
Medtronic
Baxter
Johnson and Johnson
AstraZeneca

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