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Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
Citi
Covington
Mallinckrodt
Johnson and Johnson
Federal Trade Commission
Baxter
Teva
Chubb

Generated: May 22, 2018

DrugPatentWatch Database Preview

GATTEX KIT Drug Profile

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When do Gattex Kit patents expire, 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 eleven 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 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 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 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
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 Submissiondate
➤ Subscribe Injection 5 mg/vial ➤ Subscribe 2016-12-21

Non-Orange Book US Patents for GATTEX KIT

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,846,625 Glucagon-like peptide-2 analogs ➤ Sign Up
6,184,201 Intestinotrophic glucagon-like peptide-2 analogs ➤ Sign Up
5,834,428 Glucagon-like peptide-2 and its therapeutic use ➤ Sign Up
7,888,317 Glucagon-like peptide-2 and its therapeutic use ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for GATTEX KIT

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
90009-7 Sweden ➤ Sign Up PRODUCT NAME: TEDUGLUTID; REG. NO/DATE: EU/1/12/787/001 20120830
00578 Netherlands ➤ Sign Up PRODUCT NAME: TEDUGLUTIDE OR A PHARMACEUTICALLY ACCEPTABLE FORM THEREOF; REGISTRATION NO/DATE: EU/1/12/787/001 20120830
153 Luxembourg ➤ Sign Up PRODUCT NAME: TEDUGLUTIDE SOUS TOUTES SES FORMES, TELLES QU ELLES SONT PROTEGEES PAR LE BREVET DE BASE
13/006 Ireland ➤ Sign Up PRODUCT NAME: TEDUGLUTIDE; REGISTRATION NO/DATE: EU/1/12/787/001 20120830
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
Colorcon
Deloitte
Cipla
Boehringer Ingelheim
Baxter
Daiichi Sankyo
Federal Trade Commission
McKesson

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