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LEVEMIR FLEXTOUCH Drug Profile

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Levemir Flextouch is a drug marketed by Novo Nordisk Inc and is included in one NDA. It is available from four suppliers. There are ten 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:10
Applicants:1
NDAs:1
Suppliers / Packagers: see list4
Drug Prices: :see details

Pharmacology for Tradename: LEVEMIR FLEXTOUCH

Ingredient-typeInsulin
Drug ClassInsulin Analog
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novo Nordisk Inc
LEVEMIR FLEXTOUCH
insulin detemir recombinant
INJECTABLE;SUBCUTANEOUS021536-005Oct 31, 2013RXYes5,750,497► subscribeYY ► subscribe
Novo Nordisk Inc
LEVEMIR FLEXTOUCH
insulin detemir recombinant
INJECTABLE;SUBCUTANEOUS021536-005Oct 31, 2013RXYes9,108,002► subscribeY ► subscribe
Novo Nordisk Inc
LEVEMIR FLEXTOUCH
insulin detemir recombinant
INJECTABLE;SUBCUTANEOUS021536-005Oct 31, 2013RXYes9,132,239► 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
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
Japan5568157► subscribe
European Patent Office0792290► subscribe
Japan2010188167► 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
/2000Austria► subscribePRODUCT NAME: INSULIN ASPART/PROTAMIN; NAT. REGISTRATION NO/DATE: EU/1/00/142/001-008 20000801; FIRST REGISTRATION: LI 55414-55416 20000623
2107069/01Switzerland► subscribePRODUCT NAME: INSULIN DEGLUDEC; REGISTRATION NO/DATE: SWISSMEDIC 62563 12.03.2013
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
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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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