Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

Get the Book: Make Better Decisions

Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

PDF eBook: Just $10 Get Print Book on Amazon

Serving leading biopharmaceutical companies globally:

Colorcon
Boehringer Ingelheim
Harvard Business School
McKesson
Merck
Johnson and Johnson

Last Updated: October 23, 2019

DrugPatentWatch Database Preview

LINZESS Drug Profile

See Plans and Pricing

« Back to Dashboard

When do Linzess patents expire, and when can generic versions of Linzess launch?

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

This drug has one hundred and fifty-eight patent family members in thirty-eight 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.

Drug patent expirations by year for LINZESS
Drug Prices for LINZESS

See drug prices for LINZESS

Drug Sales Revenue Trends for LINZESS

See drug sales revenues for LINZESS

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

See all LINZESS clinical trials

Recent Litigation for LINZESS

Identify potential future generic entrants

District Court Litigation
Case NameDate
Forest Laboratories Holdings, Ltd. v. Mylan Pharmaceuticals Inc.2018-12-19
Forest Laboratories Holdings, Ltd. v. Mylan Pharmaceuticals Inc.2018-03-29
Forest Laboratories Holdings, Ltd. v. Teva Pharmaceuticals USA, Inc.2018-02-02

See all LINZESS litigation

Pharmacology for LINZESS
Synonyms for LINZESS
((3S,6R,9S,15R,20R,23S,26S,29R,32R,37R,40S,45aS)-32-amino-40-(2-amino-2-oxoethyl)-26-(2-carboxyethyl)-23-(4-hydroxybenzyl)-9-((R)-1-hydroxyethyl)-3-methyl-1,4,7,10,13,22,25,28,31,3
8,41,47-dodecaoxotetracontahydro-19H-37,20-(epiminomethano)-6,29-(methanodithiomethano)pyrrolo[2,1-s][1,2,27,28]tetrathia[5,8,11,14,17,20,23,32,35,38,41]undecaazacyclotritetracontine-15-carbonyl)-L-ty
851199-59-2
ASP 0456
CHEBI:68551
CHEMBL3301675
Constella (TN)
Cys Cys Glu Tyr Cys Cys Asn Pro Ala Cys Thr Gly Cys Tyr (disulfide bridge: 1-6; 2-10; 5-13)
D09355
DB08890
DTXSID90234256
HSDB 8224
L-cysteinyl-L-cysteinyl-L-alpha-glutamyl-L-tyrosyl-L-cysteinyl-L-cysteinyl-L-asparaginyl-L-prolyl-L-alanyl-L-cysteinyl-L-threonylglycyl-L-cysteinyl-L-tyrosine cyclic (1->6),(2->10),(5->13)-tris(disulfide)
L-Tyrosine, L-cysteinyl-L-cysteinyl-L-alpha-glutamyl-L-tyrosyl-L-cysteinyl-L-cysteinyl-L-asparaginyl-L-prolyl-L-alanyl-L-cysteinyl-L-threonylglycyl-L-cysteinyl-, cyclic (1->6),(2->10),(5->13)-tris(disulfide)
Linaclotide
Linaclotide (JAN/USAN)
Linaclotide [USAN:INN]
Linzess (TN)
rosine
SCHEMBL13114620

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 Sales Llc LINZESS linaclotide CAPSULE;ORAL 202811-002 Aug 30, 2012 RX Yes No   Start Trial   Start Trial Y   Start Trial
Allergan Sales Llc LINZESS linaclotide CAPSULE;ORAL 202811-002 Aug 30, 2012 RX Yes No   Start Trial   Start Trial Y   Start Trial
Allergan Sales Llc LINZESS linaclotide CAPSULE;ORAL 202811-002 Aug 30, 2012 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
Allergan Sales Llc LINZESS linaclotide CAPSULE;ORAL 202811-003 Jan 25, 2017 RX Yes Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration
Paragraph IV (Patent) Challenges for LINZESS
Drugname Dosage Strength RLD Date
➤ Subscribe Capsules 145 mcg and 290 mcg ➤ Subscribe   Start Trial

Supplementary Protection Certificates for LINZESS

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2246360 C300594 Netherlands   Start Trial PRODUCT NAME: LINACLOTIDE; REGISTRATION NO/DATE: EU/1/12/801/001-004 20121126
1594517 CA 2013 00026 Denmark   Start Trial
1594517 466 Finland   Start Trial
2246360 CA 2013 00027 Denmark   Start Trial
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Dow
Merck
McKinsey
Harvard Business School
Mallinckrodt
Medtronic

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 verifification 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.