DrugPatentWatch Database Preview

Linaclotide - Generic Drug Details

« Back to Dashboard

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

Linaclotide is the generic ingredient in two branded drugs marketed by Mylan and Allergan, and is included in two NDAs. There are twelve 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 ninety-nine patent family members in forty-two countries.

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

Summary for linaclotide

International Patents:	199
US Patents:	12
Tradenames:	2
Applicants:	2
NDAs:	2
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	30
Clinical Trials:	37
Patent Applications:	1,196
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for linaclotide
What excipients (inactive ingredients) are in linaclotide?	linaclotide excipients list
DailyMed Link:	linaclotide at DailyMed

Recent Clinical Trials for linaclotide

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

Sponsor	Phase
Jiangsu Hansoh Pharmaceutical Co., Ltd.	Phase 3
Allergan	Phase 2
Allergan	Phase 3

See all linaclotide clinical trials

Pharmacology for linaclotide

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

Anatomical Therapeutic Chemical (ATC) Classes for linaclotide

A06AX	Other drugs for constipation
A06A	DRUGS FOR CONSTIPATION
A06	DRUGS FOR CONSTIPATION
A	Alimentary tract and metabolism

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

International Patents for linaclotide

Country	Patent Number	Estimated Expiration
South Africa	201101523
South Korea	20170016522
Netherlands	300593
Canada	2790213
Taiwan	I531374
Mexico	340234

Supplementary Protection Certificates for linaclotide

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1594517	466	Finland
1594517	92200	Luxembourg		PRODUCT NAME: LINACLOTIDE ET TOUTE FORME THERAPEUTIQUE EQUIVALENTE DE CELUI-CI, PROTEGE PAR LE BREVET DE BASE, Y COMPRIS DES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/12/801/001-004 20121126
1594517	C 2013 015	Romania		PRODUCT NAME: LINACLOTIDA SI FIECARE FORMA ECHIVALENTA TERAPEUTIC A ACESTEIA, ASA CUM SUNT PROTEJATE DE BREVETUL DE BAZA, INCLUZAND SARURILE ACCEPTABILE FARMACEUTIC; NATIONAL AUTHORISATION NUMBER: EU/1/12/801/001-004; DATE OF NATIONAL AUTHORISATION: 20121126; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/12/801/001-004; DATE OF FIRST AUTHORISATION IN EEA: 20121126
2246360	92201	Luxembourg		PRODUCT NAME: LINACLOTIDE ET TOUTE FORME THERAPEUTIQUE EQUIVALENTE DE CELUI-CI, PROTETE PAR LE BREVET DE BASE, Y COMPRIS DES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/12/801/001-004 20121126
1594517	SPC/GB13/032	United Kingdom		PRODUCT NAME: LINACLOTIDE; REGISTERED: UK EU/1/12/801/001 20121126; UK EU/1/12/801/002 20121126; UK EU/1/12/801/003 20121126; UK EU/1/12/801/004 20121126
1594517	C300593	Netherlands		PRODUCT NAME: LINACLOTIDE; REGISTRATION NO/DATE: EU/1/12/801/001-004 20121126