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Serving 500+ biopharmaceutical companies globally:

Johnson and Johnson
UBS
US Army
Fish and Richardson
Novartis
Mallinckrodt
Fuji
Accenture
Julphar
AstraZeneca

Generated: September 26, 2017

DrugPatentWatch Database Preview

LEVEMIR PENFILL Drug Profile

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What is the patent landscape for Levemir Penfill, and when can generic versions of Levemir Penfill launch?

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

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

The generic ingredient in LEVEMIR PENFILL 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 PENFILL

Patents:2
Applicants:1
NDAs:1
Suppliers / Packagers: see list3
Clinical Trials: see list68
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:LEVEMIR PENFILL at DailyMed

Pharmacology for Tradename: LEVEMIR PENFILL

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 PENFILL
insulin detemir recombinant
INJECTABLE;SUBCUTANEOUS021536-004Jun 16, 2005DISCNNoNo► Subscribe► SubscribeY ► Subscribe
Novo Nordisk Inc
LEVEMIR PENFILL
insulin detemir recombinant
INJECTABLE;SUBCUTANEOUS021536-004Jun 16, 2005DISCNNoNo► Subscribe► SubscribeYY ► Subscribe
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Expired Patents for Tradename: LEVEMIR PENFILL

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novo Nordisk Inc
LEVEMIR PENFILL
insulin detemir recombinant
INJECTABLE;SUBCUTANEOUS021536-004Jun 16, 2005► Subscribe► Subscribe
Novo Nordisk Inc
LEVEMIR PENFILL
insulin detemir recombinant
INJECTABLE;SUBCUTANEOUS021536-004Jun 16, 2005► Subscribe► Subscribe
Novo Nordisk Inc
LEVEMIR PENFILL
insulin detemir recombinant
INJECTABLE;SUBCUTANEOUS021536-004Jun 16, 2005► Subscribe► Subscribe
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Non-Orange Book Patents for Tradename: LEVEMIR PENFILL

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 PENFILL

Country Document Number Estimated Expiration
Germany122004000035► Subscribe
Brazil9709845► Subscribe
Norway961070► Subscribe
South Korea100451778► Subscribe
Poland189964► Subscribe
Slovenia792290► Subscribe
Poland178466► Subscribe
Hungary9600676► Subscribe
European Patent Office1132404► Subscribe
Bulgaria100420► 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 PENFILL

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0885961/01Switzerland► SubscribePRODUCT NAME: INSULIN GLULISIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 57013 02.05.2005
2013000061Germany► SubscribePRODUCT NAME: INSULIN DEGLUDEC IN ALLEN DURCH DAS BASISPATENT GESCHUETZTEN FORMEN; REGISTRATION NO/DATE: EU/1/12/807/001 EU/1/12/807/004-005 EU/1/12/807/007-009 EU/1/12/807/012-013 EU/1/12/807/015 20130121
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
2014000114Germany► SubscribePRODUCT NAME: KOMBINATION VON INSULIN DEGLUDEC UND LIRAGLUTIDE; REGISTRATION NO/DATE: EU/1/14/947 20140918
2004005,C0792290Lithuania► SubscribePRODUCT NAME: INSULIN DETEMIR; REGISTRATION NO/DATE: EU/1/04/278/001, EU/1/04/278/002, EU/1/04/278/003, EU/1/04/278/004, EU/1/04/278/005, EU/1/04/278/006, EU/1/04/278/007, EU/1/04/278/008, EU/1/04/278/00 20040601
13/34Ireland► SubscribePRODUCT: INSULIN DEGLUDEC IN ALL ITS FORMS AS THEY ARE PROTECTED BY THE BASIC PATENTS; REGISTRATION NO/DATE: IRELAND EU/1/12/807-001, 004, 005, 007-009, 012, 013 AND 015 / 21/01/2013
2209800/01Switzerland► SubscribePRODUCT NAME: INSULIN DEGLUDEC + LIRAGLUTIDE; REGISTRATION NO/DATE: SWISSMEDIC 65041 12.09.2014
2004 00029Denmark► Subscribe
91022-0Sweden► SubscribePRODUCT NAME: N EPSILONB29 MYRISTOYL- ELLER N EPSILONB29 TETRADEKANOYL-DES(B30) HUMANT INSULIN
C/GB05/024United Kingdom► SubscribePRODUCT NAME: INSULIN GLULISINE OR A PHYSIOLOGICALLY TOLERABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/04/285/001 - 020 20040929
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

QuintilesIMS
Novartis
US Department of Justice
Farmers Insurance
Baxter
Julphar
Moodys
UBS
Chinese Patent Office
Daiichi Sankyo

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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