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Last Updated: January 25, 2021

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GATTEX KIT Drug Profile

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Which patents cover Gattex Kit, and when can generic versions of Gattex Kit launch?

Gattex Kit is a drug marketed by Nps Pharms Inc and is included in one NDA. There are twenty-one patents protecting this drug and one Paragraph IV challenge.

This drug has eighty-two patent family members in eighteen countries.

The generic ingredient in GATTEX KIT is teduglutide recombinant. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the teduglutide recombinant profile page.

US ANDA Litigation and Generic Entry Outlook for Gattex Kit

Gattex Kit was eligible for patent challenges on December 21, 2016.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 16, 2026. This may change due to patent challenges or generic licensing.

There has been one patent litigation case 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 GATTEX KIT
Generic Entry Opportunity Date for GATTEX KIT
Generic Entry Date for GATTEX KIT*:
Constraining patent/regulatory exclusivity:
FDA exclusivity
NDA:
Dosage:
POWDER;SUBCUTANEOUS

*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 GATTEX KIT

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

SponsorPhase
Allegheny Singer Research InstitutePhase 3
Massachusetts General HospitalPhase 1
Ragon Institute of MGH, MIT and HarvardPhase 2

See all GATTEX KIT clinical trials

Pharmacology for GATTEX KIT

US Patents and Regulatory Information for GATTEX KIT

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Nps Pharms Inc GATTEX KIT teduglutide recombinant POWDER;SUBCUTANEOUS 203441-001 Dec 21, 2012 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Nps Pharms Inc GATTEX KIT teduglutide recombinant POWDER;SUBCUTANEOUS 203441-001 Dec 21, 2012 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Nps Pharms Inc GATTEX KIT teduglutide recombinant POWDER;SUBCUTANEOUS 203441-001 Dec 21, 2012 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Nps Pharms Inc GATTEX KIT teduglutide recombinant POWDER;SUBCUTANEOUS 203441-001 Dec 21, 2012 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Nps Pharms Inc GATTEX KIT teduglutide recombinant POWDER;SUBCUTANEOUS 203441-001 Dec 21, 2012 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Nps Pharms Inc GATTEX KIT teduglutide recombinant POWDER;SUBCUTANEOUS 203441-001 Dec 21, 2012 RX Yes Yes   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 GATTEX KIT

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0906338 1390009-7 Sweden   Start Trial PRODUCT NAME: TEDUGLUTID; REG. NO/DATE: EU/1/12/787/001 20120830
0906338 C300578 Netherlands   Start Trial PRODUCT NAME: TEDUGLUTIDE OR A PHARMACEUTICALLY ACCEPTABLE FORM THEREOF; REGISTRATION NO/DATE: EU/1/12/787/001 20120830
0906338 CA 2013 00012 Denmark   Start Trial
0906338 2013/006 Ireland   Start Trial PRODUCT NAME: TEDUGLUTIDE; REGISTRATION NO/DATE: EU/1/12/787/001 20120830
0906338 13C0013 France   Start Trial PRODUCT NAME: TEDUGLUTIDE; REGISTRATION NO/DATE: EU/1/12/787/001 20120830
0906338 92153 Luxembourg   Start Trial PRODUCT NAME: TEDUGLUTIDE SOUS TOUTES SES FORMES, TELLES QU ELLES SONT PROTEGEES PAR LE BREVET DE BASE
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Baxter
AstraZeneca
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Express Scripts
Medtronic
Moodys

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