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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. Two suppliers are listed for this compound.

Summary for linaclotide

International Patents:	147
US Patents:	10
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	10
Suppliers / Packagers:	2
Bulk Api Vendors:	15
Clinical Trials:	32
Patent Applications:	65
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for linaclotide
DailyMed Link:	linaclotide at DailyMed

Pharmacology for linaclotide

Drug Class	Guanylate Cyclase-C Agonist
Mechanism of Action	Guanylate Cyclase Activators

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

International Patents for linaclotide

Country	Document Number	Estimated Expiration
Russian Federation	2433133
Russian Federation	2543350
Mexico	PA06010205
China	101787073
World Intellectual Property Organization (WIPO)	2010019266
Japan	2016190870

Supplementary Protection Certificates for linaclotide

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0594	Netherlands		PRODUCT NAME: LINACLOTIDE; REGISTRATION NO/DATE: EU/1/12/801/001-004 20121126
2013000045	Germany		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
2013 00026	Denmark
2013013	Lithuania		PRODUCT NAME: LINACLOTIDUM; REGISTRATION NO/DATE: EU/1/12/801/001 - EU/1/12/801/004 20121126
2013 00027	Denmark
00594	Netherlands		PRODUCT NAME: LINACLOTIDE; REGISTRATION NO/DATE: EU/1/12/801/001-004 20121126