Linaclotide - Generic Drug Details

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 Aurobindo Pharma, Mylan, and Abbvie, and is included in three 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 two hundred and nineteen patent family members in forty-four countries.

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

Summary for linaclotide

International Patents:	219
US Patents:	12
Tradenames:	2
Applicants:	3
NDAs:	3
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	43
Clinical Trials:	43
Patent Applications:	943
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
AbbVie	Phase 2
AbbVie	Phase 3
Zhiguo Liu	N/A

See all linaclotide clinical trials

Generic filers with tentative approvals for LINACLOTIDE

Applicant	Application No.	Strength	Dosage Form
		72MCG	CAPSULE;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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	Strength	NDA	ANDAs Submitted	Submissiondate
LINZESS	Capsules	linaclotide	72 mcg	202811	1	2017-11-07
LINZESS	Capsules	linaclotide	145 mcg and 290 mcg	202811	4	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
Abbvie	LINZESS	linaclotide	CAPSULE;ORAL	202811-001	Aug 30, 2012		RX	Yes	Yes
Mylan	LINACLOTIDE	linaclotide	CAPSULE;ORAL	209564-001	Feb 9, 2021		DISCN	No	No
Abbvie	LINZESS	linaclotide	CAPSULE;ORAL	202811-002	Aug 30, 2012		RX	Yes	No
Abbvie	LINZESS	linaclotide	CAPSULE;ORAL	202811-003	Jan 25, 2017		RX	Yes	Yes			Y	Y
Abbvie	LINZESS	linaclotide	CAPSULE;ORAL	202811-001	Aug 30, 2012		RX	Yes	Yes				Y
Abbvie	LINZESS	linaclotide	CAPSULE;ORAL	202811-003	Jan 25, 2017		RX	Yes	Yes			Y
Abbvie	LINZESS	linaclotide	CAPSULE;ORAL	202811-002	Aug 30, 2012		RX	Yes	No			Y

Expired US Patents for linaclotide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	LINZESS	linaclotide	CAPSULE;ORAL	202811-003	Jan 25, 2017
Abbvie	LINZESS	linaclotide	CAPSULE;ORAL	202811-001	Aug 30, 2012
Abbvie	LINZESS	linaclotide	CAPSULE;ORAL	202811-003	Jan 25, 2017
Abbvie	LINZESS	linaclotide	CAPSULE;ORAL	202811-002	Aug 30, 2012
Abbvie	LINZESS	linaclotide	CAPSULE;ORAL	202811-003	Jan 25, 2017
Abbvie	LINZESS	linaclotide	CAPSULE;ORAL	202811-002	Aug 30, 2012
Abbvie	LINZESS	linaclotide	CAPSULE;ORAL	202811-003	Jan 25, 2017

EU/EMA Drug Approvals for linaclotide

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
AbbVie Deutschland GmbH & Co. KG	Constella	linaclotide	EMEA/H/C/002490 Constella is indicated for the symptomatic treatment of moderate to severe irritable-bowel syndrome with constipation (IBS-C) in adults.	Authorised	no	no	no	2012-11-26

International Patents for linaclotide

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2013025969
Singapore	153824	METHODS AND COMPOSITIONS FOR THE TREATMENT OF GASTROINTESTINAL DISORDERS
Mexico	PA05008097	METODOS Y COMPOSICIONES PARA EL TRATAMIENTO DE DESORDENES GASTROINTESTINALES. (METHODS AND COMPOSITIONS FOR THE TREATMENT OF GASTROINTESTINAL DISORDERS.)
South Korea	20120008017	LINACLOTIDE-CONTAINING FORMULATIONS FOR ORAL ADMINISTRATION
Canada	3040415	FORMULATIONS STABLES DE LINACLOTIDE (STABLE FORMULATIONS OF LINACLOTIDE)
South Korea	20220100101	경구 투여를 위한 리나클로타이드-함유 제형 (- LINACLOTIDE-CONTAINING FORMULATIONS FOR ORAL ADMINISTRATION)
Japan	5770629

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 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	CA 2013 00026	Denmark
1594517	CR 2013 00026	Denmark		PRODUCT NAME: LINACLOTID OG FARMACEUTISKE ACCEPTABLE SALTE DERAF; REG. NO/DATE: EU/1/12/801/001-004 20121128
1594517	C01594517/01	Switzerland		PRODUCT NAME: LINACLOTID; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 62684 20.06.2013
2246360	23/2013	Austria		PRODUCT NAME: LINACLOTID UND PHARMAZEUTISCH ANNEHMBARE SALZE HIERVON; REGISTRATION NO/DATE: EU/1/12/801/001-004 (MITTEILUNG) 20121128
1594517	300593	Netherlands		PRODUCT NAME: LINACLOTIDE; REGISTRATION NO/DATE: EU/1/12/801/001-004 20121128
2246360	2013C/031	Belgium		PRODUCT NAME: LINACLOTIDE EN ZIJN FARMACEUTISCH AANVAARDBARE ZOUTEN; AUTHORISATION NUMBER AND DATE: EU/1/12/801/001 20121128