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Serving leading biopharmaceutical companies globally:

Accenture
Cipla
US Department of Justice
Chubb
Healthtrust
Cerilliant
Mallinckrodt
Queensland Health
Boehringer Ingelheim
Express Scripts

Generated: December 16, 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 eighteen patents protecting this drug.

This drug has seventy-six patent family members in twenty-eight countries and forty-six supplementary protection certificates in twelve countries.

The generic ingredient in LEVEMIR 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.
Drug patent expirations by year for LEVEMIR

Pharmacology for LEVEMIR

Ingredient-typeInsulin
Drug ClassInsulin Analog

Medical Subject Heading (MeSH) Categories for LEVEMIR

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 IncLEVEMIRinsulin detemir recombinantINJECTABLE;SUBCUTANEOUS021536-001Jun 16, 2005RXYesYes► Subscribe► SubscribeY► Subscribe
Novo Nordisk IncLEVEMIR FLEXTOUCHinsulin detemir recombinantINJECTABLE;SUBCUTANEOUS021536-005Oct 31, 2013RXYesYes► Subscribe► SubscribeY► Subscribe
Novo Nordisk IncLEVEMIR INNOLETinsulin detemir recombinantINJECTABLE;SUBCUTANEOUS021536-003Jun 16, 2005DISCNNoNo► Subscribe► SubscribeYY► 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 FLEXTOUCHinsulin detemir recombinantINJECTABLE;SUBCUTANEOUS021536-005Oct 31, 2013RXYesYes► Subscribe► SubscribeY► Subscribe
Novo Nordisk IncLEVEMIR FLEXTOUCHinsulin detemir recombinantINJECTABLE;SUBCUTANEOUS021536-005Oct 31, 2013RXYesYes► Subscribe► SubscribeY► Subscribe
Novo Nordisk IncLEVEMIR FLEXPENinsulin detemir recombinantINJECTABLE;SUBCUTANEOUS021536-002Jun 16, 2005DISCNNoNo► Subscribe► SubscribeYY► Subscribe
Novo Nordisk IncLEVEMIR FLEXTOUCHinsulin detemir recombinantINJECTABLE;SUBCUTANEOUS021536-005Oct 31, 2013RXYesYes► Subscribe► SubscribeY► Subscribe
Novo Nordisk IncLEVEMIR FLEXTOUCHinsulin detemir recombinantINJECTABLE;SUBCUTANEOUS021536-005Oct 31, 2013RXYesYes► 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 IncLEVEMIRinsulin detemir recombinantINJECTABLE;SUBCUTANEOUS021536-001Jun 16, 2005► Subscribe► Subscribe
Novo Nordisk IncLEVEMIRinsulin detemir recombinantINJECTABLE;SUBCUTANEOUS021536-001Jun 16, 2005► Subscribe► Subscribe
Novo Nordisk IncLEVEMIRinsulin detemir recombinantINJECTABLE;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
Canada2171424► Subscribe
Brazil9407508► Subscribe
Slovakia282495► Subscribe
Bulgaria61611► Subscribe
Luxembourg91101► Subscribe
China1056618► Subscribe
Bulgaria100420► Subscribe
China1120019► Subscribe
Japan2009235075► Subscribe
Japan2000513344► 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
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:

Federal Trade Commission
US Army
Queensland Health
Baxter
Teva
AstraZeneca
Colorcon
Fish and Richardson
Cantor Fitzgerald
Novartis

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