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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.
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
Summary for GATTEX KIT
DrugPatentWatch® Estimated Generic Entry Opportunity Date for GATTEX KIT
*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
|Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)||Phase 3|
|Allegheny Singer Research Institute||Phase 3|
|Daniel Dante Yeh||Phase 2|
Pharmacology 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
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
|Country||Patent Number||Estimated Expiration|
|Denmark||0906338||⤷ Try it Free|
|Japan||4149497||⤷ Try it Free|
|Japan||2008518941||⤷ Try it Free|
|Hong Kong||1033324||⤷ Try it Free|
|Japan||2010159259||⤷ Try it Free|
|Canada||2251576||⤷ Try it Free|
|European Patent Office||2275438||⤷ Try it Free|
|>Country||>Patent Number||>Estimated Expiration|
|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|