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Last Updated: October 23, 2021

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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 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

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

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

International Patents for linaclotide

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Country	Patent Number	Estimated Expiration
Ecuador	SP11010897	⤷ Try it Free
World Intellectual Property Organization (WIPO)	2012021715	⤷ Try it Free
South Korea	20200105730	⤷ Try it Free
Israel	211028	⤷ Try it Free
South Korea	101704832	⤷ Try it Free
Australia	2017200588	⤷ Try it Free
>Country	>Patent Number	>Estimated Expiration

Supplementary Protection Certificates for linaclotide

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1594517	132013902159410	Italy	⤷ Try it Free	PRODUCT NAME: LINACLOTIDE(CONSTELLA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/12/801/001-2-3-4, 20121128
2246360	C300594	Netherlands	⤷ Try it Free	PRODUCT NAME: LINACLOTIDE; REGISTRATION NO/DATE: EU/1/12/801/001-004 20121126
1594517	CA 2013 00026	Denmark	⤷ Try it Free
1594517	5012-2013	Slovakia	⤷ Try it Free	PRODUCT NAME: LINACLOTIDUM; REGISTRATION NO/DATE: EU/1/12/801/001 - EU/1/12/801/004 20121126
1594517	466	Finland	⤷ Try it Free
2246360	CA 2013 00027	Denmark	⤷ Try it Free	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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