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Last Updated: January 27, 2023

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 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.

Recent Clinical Trials for linaclotide

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

SponsorPhase
Zhiguo LiuN/A
National Cancer Institute (NCI)Early Phase 1
Affiliated Hospital of Zunyi Medical UniversityN/A

See all linaclotide clinical trials

Generic filers with tentative approvals for LINACLOTIDE
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing72MCGCAPSULE;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
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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Allergan LINZESS linaclotide CAPSULE;ORAL 202811-002 Aug 30, 2012 RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Allergan LINZESS linaclotide CAPSULE;ORAL 202811-003 Jan 25, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Allergan LINZESS linaclotide CAPSULE;ORAL 202811-001 Aug 30, 2012 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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

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) See Plans and Pricing
Turkey 201711271 See Plans and Pricing
Philippines 12015501579 STABLE SOLID FORMULATION OF A GC-C RECEPTOR AGONIST POLYPEPTIDE SUITABLE FOR ORAL ADMINISTRATION See Plans and Pricing
Russian Federation 2014153593 СПОСОБЫ И КОМПОЗИЦИИ ДЛЯ ЛЕЧЕНИЯ ЖЕЛУДОЧНО-КИШЕЧНЫХ РАССТРОЙСТВ See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for linaclotide

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

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