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Serving 500+ biopharmaceutical companies globally:

Moodys
Farmers Insurance
Express Scripts
Chinese Patent Office
Queensland Health
UBS
US Army
US Department of Justice
Novartis
Covington

Generated: August 23, 2017

DrugPatentWatch Database Preview

TRESIBA Drug Profile

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What is the patent landscape for Tresiba, and what generic Tresiba alternatives are available?

Tresiba is a drug marketed by Novo Nordisk Inc and is included in one NDA. There are ten patents protecting this drug.

This drug has one hundred and nineteen patent family members in twenty-three countries.

The generic ingredient in TRESIBA is insulin degludec. There are thirty-eight drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the insulin degludec profile page.

Summary for Tradename: TRESIBA

Patents:10
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Clinical Trials: see list10
Drug Prices:see details
DailyMed Link:TRESIBA at DailyMed

Pharmacology for Tradename: TRESIBA

Ingredient-typeInsulin
Drug ClassInsulin Analog
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novo Nordisk Inc
TRESIBA
insulin degludec
SOLUTION;SUBCUTANEOUS203314-001Sep 25, 2015RXYesNo► Subscribe► SubscribeY ► Subscribe
Novo Nordisk Inc
TRESIBA
insulin degludec
SOLUTION;SUBCUTANEOUS203314-002Sep 25, 2015RXYesYes► Subscribe► SubscribeY ► Subscribe
Novo Nordisk Inc
TRESIBA
insulin degludec
SOLUTION;SUBCUTANEOUS203314-002Sep 25, 2015RXYesYes► Subscribe► Subscribe► Subscribe
Novo Nordisk Inc
TRESIBA
insulin degludec
SOLUTION;SUBCUTANEOUS203314-001Sep 25, 2015RXYesNo► Subscribe► SubscribeY ► Subscribe
Novo Nordisk Inc
TRESIBA
insulin degludec
SOLUTION;SUBCUTANEOUS203314-001Sep 25, 2015RXYesNo► Subscribe► SubscribeY ► Subscribe
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Non-Orange Book Patents for Tradename: TRESIBA

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
8,828,923Insulin derivatives► Subscribe
7,686,786Dial-down mechanism for wind-up pen► Subscribe
8,096,978Automatic injection device with a top release mechanism► Subscribe
8,357,120Injection device with torsion spring and rotatable display► Subscribe
9,616,180Automatic injection device with a top release mechanism► 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: TRESIBA

Country Document Number Estimated Expiration
Russian Federation2008152033► Subscribe
HungaryS1300033► Subscribe
Norway20061026► Subscribe
Japan4827922► Subscribe
Austria499962► 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: TRESIBA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2107069/02Switzerland► SubscribePRODUCT NAME: INSULIN DEGLUDEC + INSULIN ASPART; REGISTRATION NO/DATE: SWISSMEDIC 62648 12.09.2013
1Finland► Subscribe
2107069/01Switzerland► SubscribePRODUCT NAME: INSULIN DEGLUDEC; REGISTRATION NO/DATE: SWISSMEDIC 62563 12.03.2013
2013 00033Denmark► Subscribe
13/34Ireland► SubscribePRODUCT: INSULIN DEGLUDEC IN ALL ITS FORMS AS THEY ARE PROTECTED BY THE BASIC PATENTS; REGISTRATION NO/DATE: IRELAND EU/1/12/807-001, 004, 005, 007-009, 012, 013 AND 015 / 21/01/2013
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Federal Trade Commission
Queensland Health
McKinsey
Mallinckrodt
Julphar
Johnson and Johnson
Deloitte
QuintilesIMS
AstraZeneca
Chinese Patent Office

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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