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Last Updated: January 27, 2022

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GATTEX KIT Drug Patent 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 patents protecting this drug.

This drug has twenty-six patent family members in twelve 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 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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  Try it Free

Drug patent expirations by year for GATTEX KIT
DrugPatentWatch® Estimated Generic Entry Opportunity 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 Institute (also known as Allegheny Health Network Research Institute)Phase 3
Allegheny Singer Research InstitutePhase 3
Daniel Dante YehPhase 2

See all GATTEX KIT clinical trials

Pharmacology for GATTEX KIT

US Patents and Regulatory Information for GATTEX KIT

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

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

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

GLP-2 formulations
Patent Number: ⤷  Try it Free
Patent Expiration: ⤷  Try it Free

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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 it Free

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 ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Nps Pharms Inc GATTEX KIT teduglutide recombinant POWDER;SUBCUTANEOUS 203441-001 Dec 21, 2012 RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Nps Pharms Inc GATTEX KIT teduglutide recombinant POWDER;SUBCUTANEOUS 203441-001 Dec 21, 2012 RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Nps Pharms Inc GATTEX KIT teduglutide recombinant POWDER;SUBCUTANEOUS 203441-001 Dec 21, 2012 RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Nps Pharms Inc GATTEX KIT teduglutide recombinant POWDER;SUBCUTANEOUS 203441-001 Dec 21, 2012 RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Nps Pharms Inc GATTEX KIT teduglutide recombinant POWDER;SUBCUTANEOUS 203441-001 Dec 21, 2012 RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
Nps Pharms Inc GATTEX KIT teduglutide recombinant POWDER;SUBCUTANEOUS 203441-001 Dec 21, 2012 RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y ⤷  Try it Free
>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 2013/006 Ireland ⤷  Try it Free PRODUCT NAME: TEDUGLUTIDE; REGISTRATION NO/DATE: EU/1/12/787/001 20120830
0906338 CA 2013 00012 Denmark ⤷  Try it Free
0906338 13C0013 France ⤷  Try it Free PRODUCT NAME: TEDUGLUTIDE; REGISTRATION NO/DATE: EU/1/12/787/001 20120830
0906338 433 Finland ⤷  Try it Free
0906338 C300578 Netherlands ⤷  Try it Free PRODUCT NAME: TEDUGLUTIDE OR A PHARMACEUTICALLY ACCEPTABLE FORM THEREOF; REGISTRATION NO/DATE: EU/1/12/787/001 20120830
0906338 92153 Luxembourg ⤷  Try it Free PRODUCT NAME: TEDUGLUTIDE SOUS TOUTES SES FORMES, TELLES QU ELLES SONT PROTEGEES PAR LE BREVET DE BASE
0906338 1390009-7 Sweden ⤷  Try it Free PRODUCT NAME: TEDUGLUTID; REG. 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

Serving leading biopharmaceutical companies globally:

Baxter
AstraZeneca
Boehringer Ingelheim
Express Scripts
Medtronic
Moodys

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