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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.

Recent Clinical Trials for linaclotide

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

SponsorPhase
Jiangsu Hansoh Pharmaceutical Co., Ltd.Phase 3
AllerganPhase 2
AllerganPhase 3

See all linaclotide clinical trials

Pharmacology for linaclotide
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

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

Supplementary Protection Certificates for linaclotide

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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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
McKesson
McKinsey
Moodys
Merck
Mallinckrodt

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