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Serving hundreds of leading biopharmaceutical companies globally:

Teva
Johnson and Johnson
Argus Health
Chinese Patent Office
McKinsey
Citi
Cantor Fitzgerald
Dow
Moodys

Generated: August 18, 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 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 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 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 Date
➤ Subscribe Injection 5 mg/vial ➤ Subscribe ➤ Sign Up

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
7,888,317 Glucagon-like peptide-2 and its therapeutic use ➤ Sign Up
9,981,015 Treatment of short bowel syndrome patients with colon-in-continuity ➤ Sign Up
5,834,428 Glucagon-like peptide-2 and its therapeutic use ➤ Sign Up
8,846,625 Glucagon-like peptide-2 analogs ➤ Sign Up
6,184,201 Intestinotrophic glucagon-like peptide-2 analogs ➤ 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
2013 00012 Denmark ➤ Sign Up
C0013 France ➤ Sign Up PRODUCT NAME: TEDUGLUTIDE; REGISTRATION NO/DATE: EU/1/12/787/001 20120830
90009-7 Sweden ➤ Sign Up PRODUCT NAME: TEDUGLUTID; REG. NO/DATE: EU/1/12/787/001 20120830
3 Finland ➤ Sign Up
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:

Johnson and Johnson
Federal Trade Commission
Accenture
Argus Health
Deloitte
Express Scripts
Baxter
Chinese Patent Office
Cipla

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