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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Farmers Insurance
Chubb
Healthtrust
Deloitte
Teva
Dow
Merck
Covington
Novartis

Generated: October 17, 2017

DrugPatentWatch Database Preview

Insulin degludec - Generic Drug Details

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What are the generic sources for insulin degludec and what is the scope of insulin degludec patent protection?

Insulin degludec
is the generic ingredient in two branded drugs marketed by Novo Nordisk Inc and is included in two NDAs. There are sixteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Insulin degludec has one hundred and thirty-three patent family members in twenty-three countries and forty-six supplementary protection certificates in fifteen countries.

There are thirty-eight drug master file entries for insulin degludec. One supplier is listed for this compound.

Summary for Generic Name: insulin degludec

US Patents:16
Tradenames:2
Applicants:1
NDAs:2
Drug Master File Entries: see list38
Suppliers / Packagers: see list1
Clinical Trials: see list4,035
Drug Prices:see low prices
DailyMed Link:insulin degludec at DailyMed

Pharmacology for Ingredient: insulin degludec

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
TRESIBA
insulin degludec
SOLUTION;SUBCUTANEOUS203314-001Sep 25, 2015RXYesNo► Subscribe► Subscribe► Subscribe
Novo Nordisk Inc
TRESIBA
insulin degludec
SOLUTION;SUBCUTANEOUS203314-001Sep 25, 2015RXYesNo► Subscribe► SubscribeY ► Subscribe
Novo Nordisk Inc
TRESIBA
insulin degludec
SOLUTION;SUBCUTANEOUS203314-002Sep 25, 2015RXYesYes► Subscribe► SubscribeY ► Subscribe
Novo Nordisk Inc
XULTOPHY 100/3.6
insulin degludec; liraglutide
SOLUTION;SUBCUTANEOUS208583-001Nov 21, 2016RXYesYes► Subscribe► Subscribe► Subscribe
Novo Nordisk Inc
XULTOPHY 100/3.6
insulin degludec; liraglutide
SOLUTION;SUBCUTANEOUS208583-001Nov 21, 2016RXYesYes► Subscribe► SubscribeY ► Subscribe
Novo Nordisk Inc
TRESIBA
insulin degludec
SOLUTION;SUBCUTANEOUS203314-001Sep 25, 2015RXYesNo► Subscribe► SubscribeY ► Subscribe
Novo Nordisk Inc
TRESIBA
insulin degludec
SOLUTION;SUBCUTANEOUS203314-002Sep 25, 2015RXYesYes► Subscribe► SubscribeY ► Subscribe
Novo Nordisk Inc
TRESIBA
insulin degludec
SOLUTION;SUBCUTANEOUS203314-002Sep 25, 2015RXYesYes► Subscribe► SubscribeY ► Subscribe
Novo Nordisk Inc
TRESIBA
insulin degludec
SOLUTION;SUBCUTANEOUS203314-001Sep 25, 2015RXYesNo► Subscribe► SubscribeY ► Subscribe
Novo Nordisk Inc
TRESIBA
insulin degludec
SOLUTION;SUBCUTANEOUS203314-002Sep 25, 2015RXYesYes► Subscribe► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: insulin degludec

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
9,616,180Automatic injection device with a top release mechanism► Subscribe
7,686,786Dial-down mechanism for wind-up pen► Subscribe
8,828,923Insulin derivatives► 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 Ingredient: insulin degludec

Country Document Number Estimated Expiration
Spain2334808► Subscribe
China100571804► Subscribe
Norway340925► Subscribe
Japan2010188167► Subscribe
Russian Federation2389514► Subscribe
Japan2012506273► Subscribe
Australia2006208606► Subscribe
China1509193► Subscribe
China101060874► Subscribe
Russian Federation2008152033► 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: INSULIN DEGLUDEC

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
C0044Belgium► SubscribePRODUCT NAME: INSULIN-ASPART; NAT. REGISTRATION NO/DATE: EU/1/99/119/001 19990907; FIRST REGISTRATION: CH 55045 01 19990615
226Luxembourg► SubscribePRODUCT NAME: COMBINATION D'INSULINE DEGLUDEC ET INSULINE ASPARTE SOUS TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE; FIRST REGISTRATION DATE: 20130121
2013000062Germany► SubscribePRODUCT NAME: KOMBINATION VON INSULIN DEGLUDEC UND INSULIN ASPART IN ALLEN DURCH DAS BASISPATENT GESCHUETZTEN FORMEN; REGISTRATION NO/DATE: EU/1/12/806/001 EU/1/12/806/004-005 EU/1/12/806/007-008 20130121
0596Netherlands► SubscribePRODUCT NAME: INSULINE DEGLUDEC; NATIONAL REGISTRATION NO/DATE: EU/1/12/807/004 20130123; FIRST REGISTRATION: EU EU/1/12/807/001 20130123
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
8 5015-2013Slovakia► SubscribePRODUCT NAME: INZULIN DEGLUDEK; REGISTRATION NO/DATE: EU/1/12/807/001 - EU/1/12/807/015 20130121
C0035France► SubscribePRODUCT NAME: INSULINE DEGLUDEC; REGISTRATION NO/DATE: EU/1/12/807/001 20130121
2017 00013Denmark► SubscribePRODUCT NAME: KOMBINATION AF INSULIN DEGLUDEC OG LIRAGLUTID; NAT. REG. NO/DATE: EU/1/14/947 20140922; FIRST REG. NO/DATE: CH 65041 20140912
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
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Chinese Patent Office
Medtronic
Fuji
McKinsey
Farmers Insurance
Dow
AstraZeneca
Cerilliant
Covington
Healthtrust

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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