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Serving 500+ biopharmaceutical companies globally:

Dow
Chubb
McKesson
Fish and Richardson
Novartis
Farmers Insurance
UBS
Cerilliant
AstraZeneca
Cantor Fitzgerald

Generated: June 26, 2017

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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 nineteen patent family members in twenty-three 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

Tradenames:2
Patents:16
Applicants:1
NDAs:2
Drug Master File Entries: see list38
Suppliers / Packagers: see list1
Clinical Trials: see list3,977
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
XULTOPHY 100/3.6
insulin degludec; liraglutide
SOLUTION;SUBCUTANEOUS208583-001Nov 21, 2016RXYesYes8,684,969► SubscribeY ► Subscribe
Novo Nordisk Inc
XULTOPHY 100/3.6
insulin degludec; liraglutide
SOLUTION;SUBCUTANEOUS208583-001Nov 21, 2016RXYesYes9,108,002► SubscribeY ► Subscribe
Novo Nordisk Inc
XULTOPHY 100/3.6
insulin degludec; liraglutide
SOLUTION;SUBCUTANEOUS208583-001Nov 21, 2016RXYesYes9,457,154► SubscribeY ► Subscribe
Novo Nordisk Inc
XULTOPHY 100/3.6
insulin degludec; liraglutide
SOLUTION;SUBCUTANEOUS208583-001Nov 21, 2016RXYesYes6,899,699► SubscribeY ► Subscribe
Novo Nordisk Inc
TRESIBA
insulin degludec
SOLUTION;SUBCUTANEOUS203314-002Sep 25, 2015RXYesYes► 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
8,357,120Injection device with torsion spring and rotatable display► Subscribe
8,096,978Automatic injection device with a top release mechanism► Subscribe
8,828,923Insulin derivatives► Subscribe
7,686,786Dial-down mechanism for wind-up pen► Subscribe
9,616,180Automatic injection device with a top release mechanism► 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
Canada2595323► Subscribe
Russian Federation2506957► Subscribe
Russian Federation2007114761► Subscribe
European Patent Office2264066► Subscribe
China101107032► 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
2209800/01Switzerland► SubscribePRODUCT NAME: INSULIN DEGLUDEC + LIRAGLUTIDE; REGISTRATION NO/DATE: SWISSMEDIC 65041 12.09.2014
00698Netherlands► SubscribePRODUCT NAME: INSULINE DEGLUDEC EN LIRAGLUTIDE; REGISTRATION NO/DATE: EU/1/14/94765041 2014120918
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
90029-5Sweden► SubscribePRODUCT NAME: INSULIN DEGLUDEK
13/034Ireland► SubscribeAPPLICATION FOR EXTENSION OF THE DURATION OF A SUPPLEMENTARY PROTECTION CERTIFICATE 2013/034 IN JOURNAL NO. 2325 OF 25/01/2017 UNDER THE HEADING APPLICATION FOR EXTENSION OF THE DURATION OF A SUPPLEMENTARY PROTECTION CERTIFICATE, SPC NO. 2013/034 SHOULD HAVE APPEARED AS FOLLOWS, NOVO NORDISK A/S NOVO ALLE, 2880 BAGSVAERD, DENMARK (20/12/2016) PATENT NO: EP2107069; NOVEL INSULIN DERIVATIVES PRODUCT: INSULIN DEGLUDEC MARKET AUTHORISATION: EU: EU/1/12/807-001, 004, 005, 007-009, 012, 013 AND 015 (21/01/2013) ORIGINAL SPC EXPIRY DATE: 22/01/2028 1127 DESIGNS REGISTERED UNDER THE INDUSTRIAL DESIGNS ACT, 2001
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

AstraZeneca
Accenture
Daiichi Sankyo
Fish and Richardson
Chinese Patent Office
Dow
Novartis
Express Scripts
Chubb
McKesson

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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