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Last Updated: March 29, 2024

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GATTEX KIT Drug Patent Profile


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When do Gattex Kit patents expire, and what generic alternatives are available?

Gattex Kit is a drug marketed by Takeda Pharms Usa and is included in one NDA. There are two patents protecting this drug.

This drug has eight patent family members in seven 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.

DrugPatentWatch® 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 have been four 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 GATTEX KIT
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for GATTEX KIT
Generic Entry Date for GATTEX KIT*:
Constraining patent/regulatory exclusivity:
TREATMENT OF PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER WITH SHORT BOWEL SYNDROME (SBS) WHO ARE DEPENDENT ON PARENTERAL SUPPORT
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
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)Phase 3
TakedaPhase 2

See all GATTEX KIT clinical trials

Pharmacology for GATTEX KIT

US Patents and Regulatory Information for GATTEX KIT

GATTEX KIT is protected by two US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of GATTEX KIT is ⤷  Try a Trial.

This potential generic entry date is based on TREATMENT OF PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER WITH SHORT BOWEL SYNDROME (SBS) WHO ARE DEPENDENT ON PARENTERAL SUPPORT.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting GATTEX KIT

Treatment of short bowel syndrome patients with colon-in-continuity
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Treatment of short bowel syndrome patients with colon-in-continuity
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

FDA Regulatory Exclusivity protecting GATTEX KIT

TREATMENT OF PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER WITH SHORT BOWEL SYNDROME (SBS) WHO ARE DEPENDENT ON PARENTERAL SUPPORT
Exclusivity Expiration: ⤷  Try a Trial

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Takeda Pharms Usa GATTEX KIT teduglutide recombinant POWDER;SUBCUTANEOUS 203441-001 Dec 21, 2012 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Takeda Pharms Usa GATTEX KIT teduglutide recombinant POWDER;SUBCUTANEOUS 203441-001 Dec 21, 2012 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Takeda Pharms Usa GATTEX KIT teduglutide recombinant POWDER;SUBCUTANEOUS 203441-001 Dec 21, 2012 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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 C300578 Netherlands ⤷  Try a Trial PRODUCT NAME: TEDUGLUTIDE OR A PHARMACEUTICALLY ACCEPTABLE FORM THEREOF; REGISTRATION NO/DATE: EU/1/12/787/001 20120830
0906338 2013/006 Ireland ⤷  Try a Trial PRODUCT NAME: TEDUGLUTIDE; REGISTRATION NO/DATE: EU/1/12/787/001 20120830
0906338 13C0013 France ⤷  Try a Trial PRODUCT NAME: TEDUGLUTIDE; REGISTRATION NO/DATE: EU/1/12/787/001 20120830
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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

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.