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Last Updated: July 13, 2020

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LINZESS Drug Profile


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Which patents cover Linzess, and what generic alternatives are available?

Linzess is a drug marketed by Allergan and is included in one NDA. There are ten patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and sixty-six patent family members in thirty-nine countries.

The generic ingredient in LINZESS is linaclotide. There are ten drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the linaclotide profile page.

US ANDA Litigation and Generic Entry Outlook for Linzess

Linzess was eligible for patent challenges on August 30, 2016.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 16, 2033. This may change due to patent challenges or generic licensing.

Annual sales in 2017 were $727mm indicating the motivation for generic entry.

There have been nine patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for LINZESS
Drug Prices for LINZESS

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Drug Sales Revenue Trends for LINZESS

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Generic Entry Opportunity Date for LINZESS
Generic Entry Date for LINZESS*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
CAPSULE;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for LINZESS

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

SponsorPhase
United States Department of DefensePhase 2
Sidney Kimmel Cancer Center at Thomas Jefferson UniversityPhase 2
Allergan Sales, LLCPhase 3

See all LINZESS clinical trials

Pharmacology for LINZESS
Paragraph IV (Patent) Challenges for LINZESS
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 LINZESS

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   Start Trial   Start Trial Y   Start Trial
Allergan LINZESS linaclotide CAPSULE;ORAL 202811-002 Aug 30, 2012 RX Yes No   Start Trial   Start Trial Y   Start Trial
Allergan LINZESS linaclotide CAPSULE;ORAL 202811-002 Aug 30, 2012 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
Allergan LINZESS linaclotide CAPSULE;ORAL 202811-003 Jan 25, 2017 RX Yes Yes   Start Trial   Start Trial   Start Trial
Allergan LINZESS linaclotide CAPSULE;ORAL 202811-001 Aug 30, 2012 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Allergan LINZESS linaclotide CAPSULE;ORAL 202811-002 Aug 30, 2012 RX Yes No   Start Trial   Start Trial Y   Start Trial
>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 LINZESS

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2246360 PA2013014 Lithuania   Start Trial PRODUCT NAME: LINACLOTIDUM; REGISTRATION NO/DATE: EU/1/12/801/001 - EU/1/12/801/004 20121126
1594517 CA 2013 00026 Denmark   Start Trial
1594517 C300593 Netherlands   Start Trial PRODUCT NAME: LINACLOTIDE; REGISTRATION NO/DATE: EU/1/12/801/001-004 20121126
2246360 300594 Netherlands   Start Trial PRODUCT NAME: LINACLOTIDE; REGISTRATION NO/DATE: EU/1/12/801/001-004 20121126
2246360 C300594 Netherlands   Start Trial PRODUCT NAME: LINACLOTIDE; REGISTRATION NO/DATE: EU/1/12/801/001-004 20121126
2246360 CA 2013 00027 Denmark   Start Trial
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Medtronic
Dow
Express Scripts
Moodys
Baxter
Mallinckrodt

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.