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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Citi
Cantor Fitzgerald
Medtronic
UBS
Daiichi Sankyo
Mallinckrodt
Boehringer Ingelheim
Cerilliant
Moodys

Generated: December 12, 2017

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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.

This drug has eighty-two patent family members in eighteen countries and seven supplementary protection certificates in seven 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

Pharmacology for GATTEX KIT

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Nps Pharms IncGATTEX KITteduglutide recombinantPOWDER;SUBCUTANEOUS203441-001Dec 21, 2012RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Nps Pharms IncGATTEX KITteduglutide recombinantPOWDER;SUBCUTANEOUS203441-001Dec 21, 2012RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Nps Pharms IncGATTEX KITteduglutide recombinantPOWDER;SUBCUTANEOUS203441-001Dec 21, 2012RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Nps Pharms IncGATTEX KITteduglutide recombinantPOWDER;SUBCUTANEOUS203441-001Dec 21, 2012RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Nps Pharms IncGATTEX KITteduglutide recombinantPOWDER;SUBCUTANEOUS203441-001Dec 21, 2012RXYesYes► Subscribe► Subscribe► SubscribeYY► Subscribe
Nps Pharms IncGATTEX KITteduglutide recombinantPOWDER;SUBCUTANEOUS203441-001Dec 21, 2012RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Nps Pharms IncGATTEX KITteduglutide recombinantPOWDER;SUBCUTANEOUS203441-001Dec 21, 2012RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Nps Pharms IncGATTEX KITteduglutide recombinantPOWDER;SUBCUTANEOUS203441-001Dec 21, 2012RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Nps Pharms IncGATTEX KITteduglutide recombinantPOWDER;SUBCUTANEOUS203441-001Dec 21, 2012RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Nps Pharms IncGATTEX KITteduglutide recombinantPOWDER;SUBCUTANEOUS203441-001Dec 21, 2012RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
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Non-Orange Book Patents for Tradename: 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
8,846,625Glucagon-like peptide-2 analogs► Subscribe
5,834,428 Glucagon-like peptide-2 and its therapeutic use► Subscribe
8,933,039Glucagon-like peptide-2 analogs► Subscribe
7,888,317Glucagon-like peptide-2 and its therapeutic use► Subscribe
7,049,284Glucagon-like peptide-2 and its therapeutic use► Subscribe
7,781,401Glucagon-like peptide-2 analogs► Subscribe
6,184,201 Intestinotrophic glucagon-like peptide-2 analogs► Subscribe
5,990,077 Glucagon-like peptide-2 and its therapeutic use► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: GATTEX KIT

Country Document Number Estimated Expiration
Hong Kong1147761► Subscribe
Australia720493► Subscribe
Germany69716905► Subscribe
Spain2334864► Subscribe
Japan2008184465► Subscribe
European Patent Office1231219► Subscribe
Austria445641► Subscribe
European Patent Office1809318► Subscribe
European Patent Office2277909► Subscribe
Denmark1231219► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: GATTEX KIT

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
13/006Ireland► SubscribePRODUCT NAME: TEDUGLUTIDE; REGISTRATION NO/DATE: EU/1/12/787/001 20120830
2013 00012Denmark► Subscribe
153Luxembourg► SubscribePRODUCT NAME: TEDUGLUTIDE SOUS TOUTES SES FORMES, TELLES QU ELLES SONT PROTEGEES PAR LE BREVET DE BASE
00578Netherlands► SubscribePRODUCT NAME: TEDUGLUTIDE OR A PHARMACEUTICALLY ACCEPTABLE FORM THEREOF; REGISTRATION NO/DATE: EU/1/12/787/001 20120830
C0013France► SubscribePRODUCT NAME: TEDUGLUTIDE; REGISTRATION NO/DATE: EU/1/12/787/001 20120830
3Finland► Subscribe
90009-7Sweden► SubscribePRODUCT NAME: TEDUGLUTID; REG. NO/DATE: EU/1/12/787/001 20120830
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Serving leading biopharmaceutical companies globally:

Cerilliant
Mallinckrodt
Colorcon
Boehringer Ingelheim
Cantor Fitzgerald
Express Scripts
Harvard Business School
AstraZeneca
Chubb
Argus Health

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