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Serving hundreds of leading biopharmaceutical companies globally:

Healthtrust
Harvard Business School
Cipla
Chubb
Merck
Boehringer Ingelheim
McKesson
Argus Health
Johnson and Johnson

Generated: August 19, 2018

DrugPatentWatch Database Preview

LINZESS Drug Profile

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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 forty-seven patent family members in thirty-six countries.

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

Drug patent expirations by year 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.

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
Constella (TN)
Cys Cys Glu Tyr Cys Cys Asn Pro Ala Cys Thr Gly Cys Tyr (disulfide bridge: 1-6; 2-10; 5-13)
D00GNJ
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)
Linaclotide [USAN:INN]
Linzess (TN)
MD-1100 acetate
N0TXR0XR5X
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 Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Allergan Sales Llc LINZESS linaclotide CAPSULE;ORAL 202811-002 Aug 30, 2012 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Allergan Sales Llc LINZESS linaclotide CAPSULE;ORAL 202811-002 Aug 30, 2012 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Allergan Sales Llc LINZESS linaclotide CAPSULE;ORAL 202811-003 Jan 25, 2017 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Allergan Sales Llc LINZESS linaclotide CAPSULE;ORAL 202811-001 Aug 30, 2012 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Paragraph IV (Patent) Challenges for LINZESS
Drugname Dosage Strength RLD Date
➤ Subscribe Capsules 145 mcg and 290 mcg ➤ Subscribe ➤ Try a Free Trial

Non-Orange Book US Patents for LINZESS

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
7,772,188 Methods and compositions for the treatment of gastrointestinal disorders ➤ Try a Free Trial
2,014,073,571 ➤ Try a Free Trial
7,910,546 Methods and compositions for the treatment of gastrointestinal disorders ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for LINZESS

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
6 Finland ➤ Try a Free Trial
2013000045 Germany ➤ Try a Free Trial PRODUCT NAME: LINACLOTID UND JEDE THERAPEUTISCH AEQUIVALENTE FORM DAVON, WELCHE DURCH DAS GRUNDPATENT GESCHUETZT IST, EINSCHLIESSLICH DESSEN PHARMAZEUTISCH VERTRAEGLICHE SALZE; REGISTRATION NO/DATE: EU/1/12/801/001-004 20121126
2013 00027 Denmark ➤ Try a Free Trial
00593 Netherlands ➤ Try a Free Trial PRODUCT NAME: LINACLOTIDE; REGISTRATION NO/DATE: EU/1/12/801/001-004 20121126
0594 Netherlands ➤ Try a Free Trial PRODUCT NAME: LINACLOTIDE; REGISTRATION NO/DATE: EU/1/12/801/001-004 20121126
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

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Citi
McKesson
US Department of Justice
Johnson and Johnson
Merck
Farmers Insurance
Harvard Business School

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