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Cantor Fitzgerald
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Generated: March 18, 2019

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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 Sales Llc and is included in one NDA. There are ten patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and forty-seven patent family members in thirty-six 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.

Drug patent expirations by year for LINZESS
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.

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

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 Sales Llc LINZESS linaclotide CAPSULE;ORAL 202811-002 Aug 30, 2012 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Allergan Sales Llc LINZESS linaclotide CAPSULE;ORAL 202811-002 Aug 30, 2012 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Allergan Sales Llc LINZESS linaclotide CAPSULE;ORAL 202811-002 Aug 30, 2012 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Allergan Sales Llc LINZESS linaclotide CAPSULE;ORAL 202811-003 Jan 25, 2017 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Allergan Sales Llc LINZESS linaclotide CAPSULE;ORAL 202811-001 Aug 30, 2012 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Allergan Sales Llc LINZESS linaclotide CAPSULE;ORAL 202811-002 Aug 30, 2012 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Paragraph IV (Patent) Challenges for LINZESS
Drugname Dosage Strength RLD Date
➤ Subscribe Capsules 145 mcg and 290 mcg ➤ Subscribe ➤ Try a Free Trial

Supplementary Protection Certificates for LINZESS

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1594517 92200 Luxembourg ➤ Try a Free Trial PRODUCT NAME: LINACLOTIDE ET TOUTE FORME THERAPEUTIQUE EQUIVALENTE DE CELUICI,PROTEGE PAR LE BREVET DE BASE,Y COMPRIS DES SELS PHARMACEUTIQUEMENT ACCEPTABLES
1594517 300593 Netherlands ➤ Try a Free Trial PRODUCT NAME: LINACLOTIDE; REGISTRATION NO/DATE: EU/1/12/801/001-004 20121126
2246360 122013000045 Germany ➤ Try a Free 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
2246360 C300594 Netherlands ➤ Try a Free Trial PRODUCT NAME: LINACLOTIDE; REGISTRATION NO/DATE: EU/1/12/801/001-004 20121126
2246360 2013C/031 Belgium ➤ Try a Free Trial PRODUCT NAME: LINACLOTIDE EN ELKE THERAPEUTISCH EQUIVALENTE VORM DAARVAN ALS BESCHEMD DOOR HET BASISOCTROOI, WAARONDER FARMACEUTISCH AANVAARDBARE ZOUTEN; AUTHORISATION NUMBER AND DATE: EU/1/12/801/001 20121128
1594517 PA2013013 Lithuania ➤ Try a Free Trial PRODUCT NAME: LINACLOTIDUM; REGISTRATION NO/DATE: EU/1/12/801/001 - EU/1/12/801/004 20121126
Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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