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 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 two hundred and eight patent family members in forty-two 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:	208
US Patents:	12
Tradenames:	2
Applicants:	2
NDAs:	2
Drug Master File Entries:	10
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	39
Clinical Trials:	41
Patent Applications:	1,337
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
Zhiguo Liu	N/A
National Cancer Institute (NCI)	Early Phase 1
Affiliated Hospital of Zunyi Medical University	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

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

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
Hong Kong	1161978	適合口服給藥的鳥苷酸環化酶- 受體激動劑多肽的穩定的固體製劑 (STABLE SOLID FORMULATION OF A GC-C RECEPTOR AGONIST POLYPEPTIDE SUITABLE FOR ORAL ADMINISTRATION -C)
Turkey	201711271
Philippines	12015501579	STABLE SOLID FORMULATION OF A GC-C RECEPTOR AGONIST POLYPEPTIDE SUITABLE FOR ORAL ADMINISTRATION
Russian Federation	2014153593	СПОСОБЫ И КОМПОЗИЦИИ ДЛЯ ЛЕЧЕНИЯ ЖЕЛУДОЧНО-КИШЕЧНЫХ РАССТРОЙСТВ

Supplementary Protection Certificates for linaclotide

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2246360	300594	Netherlands		PRODUCT NAME: LINACLOTIDE; REGISTRATION NO/DATE: EU/1/12/801/001-004 20121126
1594517	PA2013013,C1594517	Lithuania		PRODUCT NAME: LINAKLOTIDAS; REGISTRATION NO/DATE: EU/1/12/801/001 - EU/1/12/801/004 20121126
1594517	1390024-6	Sweden		PRODUCT NAME: LINAKLOTID; REG. NO/DATE: EU/1/12/801/001 20121126
1594517	C300593	Netherlands		PRODUCT NAME: LINACLOTIDE; REGISTRATION NO/DATE: EU/1/12/801/001-004 20121126