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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 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 fifty-eight 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:	158
US Patents:	10
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	10
Suppliers / Packagers:	1
Bulk Api Vendors:	20
Clinical Trials:	34
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 3
United States Department of Defense	Phase 2
Sidney Kimmel Cancer Center at Thomas Jefferson University	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

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

International Patents for linaclotide

Country	Patent Number	Estimated Expiration
Japan	5559087
Peru	05432011
China	102186490
Denmark	2776055

Supplementary Protection Certificates for linaclotide

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2246360	92201	Luxembourg		PRODUCT NAME: LINACLOTIDE ET TOUTE FORME THERAPEUTIQUE EQUIVALENTE DE CELUICI,PROTETE PAR LE BREVET DE BASE,Y COMPRIS DES SELS PHARMACEUTIQUEMENT ACCEPTABLES
2246360	CA 2013 00027	Denmark
1594517	2013/023	Ireland		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
1594517	24/2013	Austria		PRODUCT NAME: LINACLOTID UND PHARMAZEUTISCH ANNEHMBAREN SALZE HIERVON; REGISTRATION NO/DATE: EU/1/12/801/001-004 (MITTEILUNG) 20121128