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 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:	44
Patent Applications:	777
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
Jinling Hospital, China	N/A
AbbVie	Phase 2
AbbVie	Phase 3

See all linaclotide clinical trials

Generic filers with tentative approvals for LINACLOTIDE

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	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

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Glossary

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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	202811-003	Jan 25, 2017		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Abbvie	LINZESS	linaclotide	CAPSULE;ORAL	202811-001	Aug 30, 2012		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Abbvie	LINZESS	linaclotide	CAPSULE;ORAL	202811-003	Jan 25, 2017		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Abbvie	LINZESS	linaclotide	CAPSULE;ORAL	202811-001	Aug 30, 2012		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Abbvie	LINZESS	linaclotide	CAPSULE;ORAL	202811-001	Aug 30, 2012		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Abbvie	LINZESS	linaclotide	CAPSULE;ORAL	202811-002	Aug 30, 2012		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Abbvie	LINZESS	linaclotide	CAPSULE;ORAL	202811-003	Jan 25, 2017		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for linaclotide

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

EU/EMA Drug Approvals for linaclotide

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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
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for linaclotide

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Country	Patent Number	Title	Estimated Expiration
Argentina	118601	FORMULACIONES SÓLIDAS ESTABLES DE UN RECEPTOR GC-C, AGONISTA POLIPEPTÍDICO ADECUADO PARA ADMINISTRACIÓN ORAL	⤷ Sign Up
New Zealand	570134	Methods and compositions for the treatment of gastrointestinal disorders	⤷ Sign Up
Mexico	2020005326	FORMULACIONES QUE CONTIENEN LINACLOTIDA PARA ADMINISTRACION ORAL. (LINACLOTIDE-CONTAINING FORMULATIONS FOR ORAL ADMINISTRATION.)	⤷ Sign Up
China	102869677	Treatments for gastrointestinal disorders	⤷ Sign Up
Japan	2022132383	経口投与に好適なＧＣ－Ｃ受容体アゴニストポリペプチドの安定な固体製剤	⤷ Sign Up
Japan	6473532		⤷ Sign Up
European Patent Office	2246360	Compositions pour le traitement de troubles gastrointestinaux (Compositions for the treatment of gastrointestinal disorders)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for linaclotide

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2246360	92201	Luxembourg	⤷ Sign Up	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	466	Finland	⤷ Sign Up
1594517	24/2013	Austria	⤷ Sign Up	PRODUCT NAME: LINACLOTID UND PHARMAZEUTISCH ANNEHMBAREN SALZE HIERVON; REGISTRATION NO/DATE: EU/1/12/801/001-004 (MITTEILUNG) 20121128
1594517	SPC/GB13/032	United Kingdom	⤷ Sign Up	PRODUCT NAME: LINACLOTIDE; REGISTERED: UK EU/1/12/801/001 20121128; UK EU/1/12/801/002 20121128; UK EU/1/12/801/003 20121128; UK EU/1/12/801/004 20121128
1594517	PA2013013,C1594517	Lithuania	⤷ Sign Up	PRODUCT NAME: LINAKLOTIDAS; REGISTRATION NO/DATE: EU/1/12/801/001 - EU/1/12/801/004 20121126
2246360	300594	Netherlands	⤷ Sign Up	PRODUCT NAME: LINACLOTIDE; REGISTRATION NO/DATE: EU/1/12/801/001-004 20121126
2246360	CA 2013 00027	Denmark	⤷ Sign Up	PRODUCT NAME: LINACLOTID OG ENHVER TERAPEUTISK AEKVIVALENT FORM DERAF SOM ER BESKYTTET AF GRUNDPATENTET, HERUNDER DE ACCEPTABLE SALTE DERAF, INKLUSIVE SALTENE AF LINACLOTID; REG. NO/DATE: EU/1/12/801/001-004 20121128
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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