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Linaclotide - Generic Drug Details

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What are the generic sources for linaclotide and what is the scope of freedom to operate?

Linaclotide is the generic ingredient in one branded drug marketed by Allergan 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 sixty-one patent family members in thirty-eight countries.

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

Summary for linaclotide

International Patents:	161
US Patents:	10
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	10
Suppliers / Packagers:	1
Bulk Api Vendors:	23
Clinical Trials:	36
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

Recent Clinical Trials for linaclotide

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

Sponsor	Phase
Allergan	Phase 2
Allergan	Phase 3
United States Department of Defense	Phase 2

See all linaclotide clinical trials

Recent Litigation for linaclotide

Identify potential future generic entrants

District Court Litigation

Case Name	Date
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 linaclotide litigation

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 (TN)

CS-3577

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

H-Cys(1)-Cys(2)-Glu-Tyr-Cys(3)-Cys(1)-Asn-Pro-Ala-Cys(2)-Thr-Gly-Cys(3)-Tyr-OH

HSDB 8224

HY-17584

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:INN]

Linzess

Linzess (TN)

rosine

SCHEMBL13114620

Paragraph IV (Patent) Challenges for LINACLOTIDE

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 linaclotide

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			Y	Y
Allergan	LINZESS	linaclotide	CAPSULE;ORAL	202811-002	Aug 30, 2012		RX	Yes	No			Y	Y
Allergan	LINZESS	linaclotide	CAPSULE;ORAL	202811-002	Aug 30, 2012		RX	Yes	No			Y
Allergan	LINZESS	linaclotide	CAPSULE;ORAL	202811-001	Aug 30, 2012		RX	Yes	Yes			Y	Y

International Patents for linaclotide

Country	Patent Number	Estimated Expiration
Norway	20130460
South Africa	200805859
World Intellectual Property Organization (WIPO)	2013025969
Japan	2013501071

Supplementary Protection Certificates for linaclotide

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2246360	122013000045	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
1594517	C01594517/01	Switzerland		PRODUCT NAME: LINACLOTID; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 62684 20.06.2013
1594517	2013C/032	Belgium		PRODUCT NAME: LINACLOTIDE EN ELKE THERAPEUTISCH EQUIVALENTE VORM DAARVAN ALS BESCHERMD DOOR HET BASISOCTROOI, WAARONDER FARMACEUTISCH AANVAARDBARE ZOUTEN; AUTHORISATION NUMBER AND DATE: EU/1/12/801/001 20121128
1594517	CA 2013 00026	Denmark