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Serving 500+ biopharmaceutical companies globally:

Accenture
Fish and Richardson
Moodys
Federal Trade Commission
Mallinckrodt
Harvard Business School
Dow
Daiichi Sankyo
Merck
Cipla

Generated: June 25, 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, 2015RXYesNo9,108,002► SubscribeY ► Subscribe
Novo Nordisk Inc
TRESIBA
insulin degludec
SOLUTION;SUBCUTANEOUS203314-002Sep 25, 2015RXYesYes8,684,969► SubscribeY ► Subscribe
Novo Nordisk Inc
TRESIBA
insulin degludec
SOLUTION;SUBCUTANEOUS203314-002Sep 25, 2015RXYesYes► Subscribe► Subscribe
Novo Nordisk Inc
TRESIBA
insulin degludec
SOLUTION;SUBCUTANEOUS203314-001Sep 25, 2015RXYesNo9,457,154► SubscribeY ► Subscribe
Novo Nordisk Inc
TRESIBA
insulin degludec
SOLUTION;SUBCUTANEOUS203314-001Sep 25, 2015RXYesNo9,132,239► 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
9,616,180Automatic injection device with a top release mechanism► Subscribe
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
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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
Japan2013154219► Subscribe
Russian Federation2006103280► Subscribe
Spain2472421► Subscribe
Portugal1351732► Subscribe
Japan4970282► 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
/2000Austria► SubscribePRODUCT NAME: INSULIN ASPART/PROTAMIN; NAT. REGISTRATION NO/DATE: EU/1/00/142/001-008 20000801; FIRST REGISTRATION: LI 55414-55416 20000623
2Finland► Subscribe
00597Netherlands► SubscribePRODUCT NAME: INSULINE DEGLUDEC EN INSULINE ASPART; REGISTRATION NO/DATE: EU/1/12/806/001EU/1/12/806/004EU/1/12/806/005EU/1/12/806/007EU/1/12/806/008 2013210121
C0035France► SubscribePRODUCT NAME: INSULINE DEGLUDEC; REGISTRATION NO/DATE: EU/1/12/807/001 20130121
90067-4Sweden► SubscribePRODUCT NAME: COMBINATION OF INSULIN DEGLUDEC AND LIRAGLUTIDE; REG. NO/DATE: EU/1/14/974 20140918
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Medtronic
Deloitte
Moodys
Johnson and Johnson
Covington
Argus Health
Julphar
Fish and Richardson
McKinsey
Novartis

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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