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Generated: March 22, 2019

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Linaclotide - Generic Drug Details

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What are the generic drug sources for linaclotide and what is the scope of linaclotide 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 forty-seven patent family members in thirty-six countries.

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

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
Constella (TN)
Cys Cys Glu Tyr Cys Cys Asn Pro Ala Cys Thr Gly Cys Tyr (disulfide bridge: 1-6; 2-10; 5-13)
D00GNJ
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 (JAN/USAN)
Linaclotide (USAN)
Linaclotide [USAN:INN]
Linzess
Linzess (TN)
MD-1100 acetate
N0TXR0XR5X
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 No ➤ Try a Free Trial ➤ Try a Free Trial 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 ➤ 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 ➤ 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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Supplementary Protection Certificates for linaclotide

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1594517 2013/023 Ireland ➤ Try a Free 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
2246360 300594 Netherlands ➤ Try a Free Trial PRODUCT NAME: LINACLOTIDE; REGISTRATION NO/DATE: EU/1/12/801/001-004 20121126
2246360 92201 Luxembourg ➤ Try a Free Trial PRODUCT NAME: LINACLOTIDE ET TOUTE FORME THERAPEUTIQUE EQUIVALENTE DE CELUICI,PROTETE 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
Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Deloitte
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Teva
Colorcon
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Citi

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