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LEVEMIR FLEXTOUCH Drug Profile

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Which patents cover Levemir Flextouch, and what substitute generic drugs are available?

Levemir Flextouch is a drug marketed by Novo Nordisk Inc and is included in one NDA. There are eleven patents protecting this drug.

This drug has one hundred and fifty-nine patent family members in twenty-eight countries.

The generic ingredient in LEVEMIR FLEXTOUCH is insulin detemir recombinant. There are thirty-eight drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the insulin detemir recombinant profile page.

Summary for Tradename: LEVEMIR FLEXTOUCH

Patents:11
Applicants:1
NDAs:1
Suppliers / Packagers: see list4
Clinical Trials: see list42
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:LEVEMIR FLEXTOUCH at DailyMed

Pharmacology for Tradename: LEVEMIR FLEXTOUCH

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
LEVEMIR FLEXTOUCH
insulin detemir recombinant
INJECTABLE;SUBCUTANEOUS021536-005Oct 31, 2013RXYesYes5,750,497► SubscribeYY ► Subscribe
Novo Nordisk Inc
LEVEMIR FLEXTOUCH
insulin detemir recombinant
INJECTABLE;SUBCUTANEOUS021536-005Oct 31, 2013RXYesYes8,920,383► SubscribeY ► Subscribe
Novo Nordisk Inc
LEVEMIR FLEXTOUCH
insulin detemir recombinant
INJECTABLE;SUBCUTANEOUS021536-005Oct 31, 2013RXYesYes9,132,239► SubscribeY ► Subscribe
Novo Nordisk Inc
LEVEMIR FLEXTOUCH
insulin detemir recombinant
INJECTABLE;SUBCUTANEOUS021536-005Oct 31, 2013RXYesYes9,108,002► SubscribeY ► Subscribe
Novo Nordisk Inc
LEVEMIR FLEXTOUCH
insulin detemir recombinant
INJECTABLE;SUBCUTANEOUS021536-005Oct 31, 2013RXYesYes8,672,898► SubscribeY ► Subscribe
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Non-Orange Book Patents for Tradename: LEVEMIR FLEXTOUCH

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
6,011,007 Acylated insulin► Subscribe
8,096,978Automatic injection device with a top release mechanism► Subscribe
6,869,930 Acylated insulin► 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: LEVEMIR FLEXTOUCH

Country Document Number Estimated Expiration
World Intellectual Property Organization (WIPO)9748414► Subscribe
Hungary217684► Subscribe
Japan4060583► Subscribe
Japan2004516895► Subscribe
World Intellectual Property Organization (WIPO)2006079481► 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: LEVEMIR FLEXTOUCH

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
/2005Austria► SubscribePRODUCT NAME: NOVOMIX 70 - SUSPENSION, ENTHALTEND LOESLICHES INSULIN ASPART UND PROTAMINKRISTALLISIERTES INSULIN ASPART IM VERHAELTNIS 70:30; REGISTRATION NO/DATE: EU/1/00/142/017 - EU/1/00/142/022 20051005
C0085France► SubscribePRODUCT NAME: LIRAGLUTIDE ET INSULINE DEGLUDEC; REGISTRATION NO/DATE: EU/1/14/947 20140918
/2005Austria► SubscribePRODUCT NAME: NOVOMIX 50 - SUSPENSION, ENTHALTEND LOESLICHES INSULIN ASPART UND PROTAMINKRISTALLISIERTES INSULIN ASPART IM VERHAELTNIS 50:50; REGISTRATION NO/DATE: EU/1/00/142/011 - EU/1/00/142/016 20051005
0596Netherlands► SubscribePRODUCT NAME: INSULINE DEGLUDEC; REGISTRATION NO/DATE: EU/1/12/807/004 20130123
90042Netherlands► SubscribePRODUCT NAME: INSULIN ASPART; REGISTRATION NO/DATE: EU/1/99/119/001 - EU/1/99/119/005 19990907
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