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Serving leading biopharmaceutical companies globally:

Cipla
Accenture
Julphar
McKinsey
Citi
QuintilesIMS
Daiichi Sankyo
AstraZeneca
Moodys
Novartis

Generated: December 16, 2017

DrugPatentWatch Database Preview

LEVEMIR FLEXPEN Drug Profile

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When do Levemir Flexpen patents expire, and when can generic versions of Levemir Flexpen launch?

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

This drug has one hundred and fifty-one patent family members in thirty countries and forty-six supplementary protection certificates in twelve countries.

The generic ingredient in LEVEMIR FLEXPEN 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 LEVEMIR FLEXPEN

Drug patent expirations by year for LEVEMIR FLEXPEN

Pharmacology for LEVEMIR FLEXPEN

Ingredient-typeInsulin
Drug ClassInsulin Analog

Medical Subject Heading (MeSH) Categories for LEVEMIR FLEXPEN

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novo Nordisk IncLEVEMIR FLEXPENinsulin detemir recombinantINJECTABLE;SUBCUTANEOUS021536-002Jun 16, 2005DISCNNoNo► Subscribe► SubscribeY► Subscribe
Novo Nordisk IncLEVEMIR FLEXPENinsulin detemir recombinantINJECTABLE;SUBCUTANEOUS021536-002Jun 16, 2005DISCNNoNo► Subscribe► SubscribeY► Subscribe
Novo Nordisk IncLEVEMIR FLEXPENinsulin detemir recombinantINJECTABLE;SUBCUTANEOUS021536-002Jun 16, 2005DISCNNoNo► Subscribe► SubscribeY► Subscribe
Novo Nordisk IncLEVEMIR FLEXPENinsulin detemir recombinantINJECTABLE;SUBCUTANEOUS021536-002Jun 16, 2005DISCNNoNo► Subscribe► SubscribeY► Subscribe
Novo Nordisk IncLEVEMIR FLEXPENinsulin detemir recombinantINJECTABLE;SUBCUTANEOUS021536-002Jun 16, 2005DISCNNoNo► Subscribe► SubscribeYY► Subscribe
Novo Nordisk IncLEVEMIR FLEXPENinsulin detemir recombinantINJECTABLE;SUBCUTANEOUS021536-002Jun 16, 2005DISCNNoNo► Subscribe► SubscribeY► Subscribe
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Expired Patents for Tradename: LEVEMIR FLEXPEN

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novo Nordisk IncLEVEMIR FLEXPENinsulin detemir recombinantINJECTABLE;SUBCUTANEOUS021536-002Jun 16, 2005► Subscribe► Subscribe
Novo Nordisk IncLEVEMIR FLEXPENinsulin detemir recombinantINJECTABLE;SUBCUTANEOUS021536-002Jun 16, 2005► Subscribe► Subscribe
Novo Nordisk IncLEVEMIR FLEXPENinsulin detemir recombinantINJECTABLE;SUBCUTANEOUS021536-002Jun 16, 2005► Subscribe► Subscribe
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Non-Orange Book Patents for Tradename: LEVEMIR FLEXPEN

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
6,582,404 Dose setting limiter► Subscribe
6,235,004 Injection syringe► 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 FLEXPEN

Country Document Number Estimated Expiration
World Intellectual Property Organization (WIPO)9938554► Subscribe
Germany60043595► Subscribe
Canada2171424► Subscribe
Brazil9407508► Subscribe
Slovakia282495► Subscribe
Bulgaria61611► Subscribe
Luxembourg91101► Subscribe
China1056618► Subscribe
Bulgaria100420► Subscribe
China1120019► 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 FLEXPEN

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0885961/01Switzerland► SubscribePRODUCT NAME: INSULIN GLULISIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 57013 02.05.2005
C0009France► SubscribePRODUCT NAME: INSULINE GLULISINE; REGISTRATION NO/DATE IN FRANCE: EU/1/04/258/001 DU 20040927; REGISTRATION NO/DATE AT EEC: EU/1/04/285/001 DU 20040927
2/2005Austria► SubscribePRODUCT NAME: INSULIN GLULISINE
C/GB05/024United Kingdom► SubscribePRODUCT NAME: INSULIN GLULISINE OR A PHYSIOLOGICALLY TOLERABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/04/285/001 - 020 20040929
90067-4Sweden► SubscribePRODUCT NAME: COMBINATION OF INSULIN DEGLUDEC AND LIRAGLUTIDE; REG. NO/DATE: EU/1/14/974 20140918
101Luxembourg► Subscribe91101, EXPIRES: 20190601
2017000040Germany► SubscribePRODUCT NAME: SCHNELL-WIRKENDES INSULIN ASPART; REGISTRATION NO/DATE: EU/1/16/1160 20170109
C0035France► SubscribePRODUCT NAME: INSULINE DEGLUDEC; REGISTRATION NO/DATE: EU/1/12/807/001 20130121
60026Netherlands► SubscribePRODUCT NAME: INSULINUM LISPRUM, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/96/007/001 - EU/1/96/007/003 19960430
2107069/01Switzerland► SubscribePRODUCT NAME: INSULIN DEGLUDEC; REGISTRATION NO/DATE: SWISSMEDIC 62563 12.03.2013
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For more information try a trial or see the plans and pricing

Serving leading biopharmaceutical companies globally:

US Army
Daiichi Sankyo
Citi
US Department of Justice
Cipla
QuintilesIMS
Federal Trade Commission
Julphar
McKesson
Farmers Insurance

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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