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Serving hundreds of leading biopharmaceutical companies globally:

UBS
Harvard Business School
QuintilesIMS
Baxter
Daiichi Sankyo
Argus Health

Generated: March 25, 2019

DrugPatentWatch Database Preview

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.

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:
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.

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 ➤ Sign Up ➤ Sign Up ➤ Sign Up
Nps Pharms Inc GATTEX KIT teduglutide recombinant POWDER;SUBCUTANEOUS 203441-001 Dec 21, 2012 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Nps Pharms Inc GATTEX KIT teduglutide recombinant POWDER;SUBCUTANEOUS 203441-001 Dec 21, 2012 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Nps Pharms Inc GATTEX KIT teduglutide recombinant POWDER;SUBCUTANEOUS 203441-001 Dec 21, 2012 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Nps Pharms Inc GATTEX KIT teduglutide recombinant POWDER;SUBCUTANEOUS 203441-001 Dec 21, 2012 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Nps Pharms Inc GATTEX KIT teduglutide recombinant POWDER;SUBCUTANEOUS 203441-001 Dec 21, 2012 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Nps Pharms Inc GATTEX KIT teduglutide recombinant POWDER;SUBCUTANEOUS 203441-001 Dec 21, 2012 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
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 GATTEX KIT
Drugname Dosage Strength RLD Date
➤ Subscribe Injection 5 mg/vial ➤ Subscribe ➤ Sign Up

Supplementary Protection Certificates for GATTEX KIT

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0906338 2013/006 Ireland ➤ Sign Up PRODUCT NAME: TEDUGLUTIDE; REGISTRATION NO/DATE: EU/1/12/787/001 20120830
0906338 1390009-7 Sweden ➤ Sign Up PRODUCT NAME: TEDUGLUTID; REG. NO/DATE: EU/1/12/787/001 20120830
0906338 433 Finland ➤ Sign Up
0906338 92153 Luxembourg ➤ Sign Up PRODUCT NAME: TEDUGLUTIDE SOUS TOUTES SES FORMES, TELLES QU ELLES SONT PROTEGEES PAR LE BREVET DE BASE
0906338 CA 2013 00012 Denmark ➤ Sign Up
0906338 13C0013 France ➤ Sign Up PRODUCT NAME: TEDUGLUTIDE; REGISTRATION NO/DATE: EU/1/12/787/001 20120830
0906338 C300578 Netherlands ➤ Sign Up PRODUCT NAME: TEDUGLUTIDE OR A PHARMACEUTICALLY ACCEPTABLE FORM THEREOF; REGISTRATION NO/DATE: EU/1/12/787/001 20120830
Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

AstraZeneca
QuintilesIMS
Julphar
Accenture
Fish and Richardson
Harvard Business School

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