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Serving 500+ biopharmaceutical companies globally:

Medtronic
US Army
Baxter
UBS
Boehringer Ingelheim
Julphar
QuintilesIMS
US Department of Justice
McKesson
Merck

Generated: July 27, 2017

DrugPatentWatch Database Preview

LEVEMIR Drug Profile

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Which patents cover Levemir, and when can generic versions of Levemir launch?

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

This drug has seventy-three patent family members in twenty-eight countries.

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

Summary for Tradename: LEVEMIR

Patents:2
Applicants:1
NDAs:1
Suppliers / Packagers: see list3
Clinical Trials: see list89
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:LEVEMIR at DailyMed

Pharmacology for Tradename: LEVEMIR

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
LEVEMIR
insulin detemir recombinant
INJECTABLE;SUBCUTANEOUS021536-001Jun 16, 2005RXYesYes► Subscribe► SubscribeY ► Subscribe
Novo Nordisk Inc
LEVEMIR FLEXTOUCH
insulin detemir recombinant
INJECTABLE;SUBCUTANEOUS021536-005Oct 31, 2013RXYesYes► Subscribe► SubscribeY ► Subscribe
Novo Nordisk Inc
LEVEMIR PENFILL
insulin detemir recombinant
INJECTABLE;SUBCUTANEOUS021536-004Jun 16, 2005DISCNNoNo► Subscribe► SubscribeYY ► Subscribe
Novo Nordisk Inc
LEVEMIR FLEXPEN
insulin detemir recombinant
INJECTABLE;SUBCUTANEOUS021536-002Jun 16, 2005DISCNNoNo► Subscribe► SubscribeY ► Subscribe
Novo Nordisk Inc
LEVEMIR FLEXPEN
insulin detemir recombinant
INJECTABLE;SUBCUTANEOUS021536-002Jun 16, 2005DISCNNoNo► Subscribe► SubscribeY ► Subscribe
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Expired Patents for Tradename: LEVEMIR

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novo Nordisk Inc
LEVEMIR
insulin detemir recombinant
INJECTABLE;SUBCUTANEOUS021536-001Jun 16, 2005► Subscribe► Subscribe
Novo Nordisk Inc
LEVEMIR
insulin detemir recombinant
INJECTABLE;SUBCUTANEOUS021536-001Jun 16, 2005► Subscribe► Subscribe
Novo Nordisk Inc
LEVEMIR
insulin detemir recombinant
INJECTABLE;SUBCUTANEOUS021536-001Jun 16, 2005► Subscribe► Subscribe
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Non-Orange Book Patents for Tradename: LEVEMIR

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
6,869,930 Acylated insulin► 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

Country Document Number Estimated Expiration
Spain2167751► Subscribe
European Patent Office0792290► Subscribe
Norway985981► Subscribe
Slovakia282495► Subscribe
Japan2000060556► 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

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2004 00029Denmark► Subscribe
0160Netherlands► Subscribe300160, 20140916, EXPIRES: 20181109
91022-0Sweden► SubscribePRODUCT NAME: N EPSILONB29 MYRISTOYL- ELLER N EPSILONB29 TETRADEKANOYL-DES(B30) HUMANT INSULIN
C/GB00/027United Kingdom► SubscribePRODUCT NAME: INSULIN ASPART AND PROTAMINE (NOVOMIX 30); REGISTERED: CH 55414 01 20000623; CH 55415 02 20000623; CH 55416 02 20000623; UK EU/1/00/142/001-008 20000801
226Luxembourg► SubscribePRODUCT NAME: COMBINATION D'INSULINE DEGLUDEC ET INSULINE ASPARTE SOUS TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE; FIRST REGISTRATION DATE: 20130121
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Teva
Julphar
McKesson
Moodys
Federal Trade Commission
Cipla
Johnson and Johnson
Chubb
Cantor Fitzgerald
US Army

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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