DrugPatentWatch Database Preview

Linaclotide - Generic Drug Details

« Back to Dashboard

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. Three 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:	3
Bulk Api Vendors:	5
Clinical Trials:	30
Patent Applications:	1
Formulation / Manufacturing:	see details
Drug Prices:	see low prices
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	202811-002	Aug 30, 2012		RX	Yes	Yes			Y
Allergan Sales Llc	LINZESS	linaclotide	CAPSULE;ORAL	202811-001	Aug 30, 2012		RX	Yes	No
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

Non-Orange Book US Patents for linaclotide

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
7,910,546	Methods and compositions for the treatment of gastrointestinal disorders
2,014,073,571
7,772,188	Methods and compositions for the treatment of gastrointestinal disorders

International Patents for linaclotide

Country	Document Number	Estimated Expiration
European Patent Office	1730172
Japan	2014524444
New Zealand	570134
Ecuador	SP11010897

Supplementary Protection Certificates for linaclotide

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
6	Finland
0594	Netherlands		PRODUCT NAME: LINACLOTIDE; REGISTRATION NO/DATE: EU/1/12/801/001-004 20121126
00593	Netherlands		PRODUCT NAME: LINACLOTIDE; REGISTRATION NO/DATE: EU/1/12/801/001-004 20121126
2013013	Lithuania		PRODUCT NAME: LINACLOTIDUM; REGISTRATION NO/DATE: EU/1/12/801/001 - EU/1/12/801/004 20121126