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TRESIBA Drug Profile

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Which patents cover Tresiba, and what substitute generic drugs 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 eighteen patent family members in twenty-two 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 list6
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 Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novo Nordisk Inc
TRESIBA
insulin degludec
SOLUTION;SUBCUTANEOUS203314-001Sep 25, 2015RXYesNo7,686,786► SubscribeY ► Subscribe
Novo Nordisk Inc
TRESIBA
insulin degludec
SOLUTION;SUBCUTANEOUS203314-002Sep 25, 2015RXYesYes6,899,699► 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, 2015RXYesNo9,132,239► SubscribeY ► Subscribe
Novo Nordisk Inc
TRESIBA
insulin degludec
SOLUTION;SUBCUTANEOUS203314-001Sep 25, 2015RXYesNo9,457,154► 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
8,357,120Injection device with torsion spring and rotatable display► Subscribe
8,096,978Automatic 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
Canada2594764► Subscribe
European Patent Office2264066► Subscribe
South Korea20070084392► Subscribe
Japan2008517233► 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
0596Netherlands► SubscribePRODUCT NAME: INSULINE DEGLUDEC; REGISTRATION NO/DATE: EU/1/12/807/004 20130123
1Finland► Subscribe
2004005,C0792290Lithuania► SubscribePRODUCT NAME: INSULIN DETEMIR; REGISTRATION NO/DATE: EU/1/04/278/001, EU/1/04/278/002, EU/1/04/278/003, EU/1/04/278/004, EU/1/04/278/005, EU/1/04/278/006, EU/1/04/278/007, EU/1/04/278/008, EU/1/04/278/00 20040601
90036-0Sweden► SubscribePRODUCT NAME: KOMBINATION AV INSULIN DEGLUDEK OCH INSULIN ASPART; REG. NO/DATE: EU/1/12/806/001 20130121
91022-0Sweden► SubscribePRODUCT NAME: N EPSILONB29 MYRISTOYL- ELLER N EPSILONB29 TETRADEKANOYL-DES(B30) HUMANT INSULIN
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