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Express Scripts
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Generated: December 18, 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 seventeen 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-nine 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 insulin degludec

Pharmacology for 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 IncXULTOPHY 100/3.6insulin degludec; liraglutideSOLUTION;SUBCUTANEOUS208583-001Nov 21, 2016RXYesYes► Subscribe► SubscribeYY► Subscribe
Novo Nordisk IncXULTOPHY 100/3.6insulin degludec; liraglutideSOLUTION;SUBCUTANEOUS208583-001Nov 21, 2016RXYesYes► Subscribe► SubscribeYY► Subscribe
Novo Nordisk IncTRESIBAinsulin degludecSOLUTION;SUBCUTANEOUS203314-002Sep 25, 2015RXYesYes► Subscribe► SubscribeY► Subscribe
Novo Nordisk IncTRESIBAinsulin degludecSOLUTION;SUBCUTANEOUS203314-002Sep 25, 2015RXYesYes► Subscribe► SubscribeY► Subscribe
Novo Nordisk IncXULTOPHY 100/3.6insulin degludec; liraglutideSOLUTION;SUBCUTANEOUS208583-001Nov 21, 2016RXYesYes► Subscribe► Subscribe► Subscribe
Novo Nordisk IncXULTOPHY 100/3.6insulin degludec; liraglutideSOLUTION;SUBCUTANEOUS208583-001Nov 21, 2016RXYesYes► Subscribe► SubscribeY► Subscribe
Novo Nordisk IncTRESIBAinsulin degludecSOLUTION;SUBCUTANEOUS203314-001Sep 25, 2015RXYesNo► Subscribe► SubscribeY► Subscribe
Novo Nordisk IncXULTOPHY 100/3.6insulin degludec; liraglutideSOLUTION;SUBCUTANEOUS208583-001Nov 21, 2016RXYesYes► Subscribe► SubscribeY► Subscribe
Novo Nordisk IncXULTOPHY 100/3.6insulin degludec; liraglutideSOLUTION;SUBCUTANEOUS208583-001Nov 21, 2016RXYesYes► Subscribe► SubscribeY► Subscribe
Novo Nordisk IncTRESIBAinsulin degludecSOLUTION;SUBCUTANEOUS203314-001Sep 25, 2015RXYesNo► Subscribe► SubscribeY► 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
7,686,786Dial-down mechanism for wind-up pen► Subscribe
8,828,923Insulin derivatives► Subscribe
9,616,180Automatic injection device with a top release mechanism► Subscribe
8,096,978Automatic 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
European Patent Office2275439► Subscribe
Spain2361563► Subscribe
European Patent Office2264065► Subscribe
Australia2006207744► Subscribe
Australia2004261353► Subscribe
Japan2012506273► Subscribe
Australia2010200497► Subscribe
Norway20061026► Subscribe
Austria499962► Subscribe
Russian Federation2011118236► 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
/2004Austria► SubscribePRODUCT NAME: INSULIN-DETEMIR UND PHARMAZEUTISCH ANNEHMBARE ZN-SALZE DAVON; NAT. REGISTRATION NO/DATE: EU/1/04/278/001-009 20040601; FIRST REGISTRATION: LI 56370 56371 56372 20031110
/2000Austria► SubscribePRODUCT NAME: INSULIN ASPART/PROTAMIN; NAT. REGISTRATION NO/DATE: EU/1/00/142/001-008 20000801; FIRST REGISTRATION: LI 55414-55416 20000623
00597Netherlands► SubscribePRODUCT NAME: INSULINE DEGLUDEC EN INSULINE ASPART; REGISTRATION NO/DATE: EU/1/12/806/001EU/1/12/806/004EU/1/12/806/005EU/1/12/806/007EU/1/12/806/008 2013210121
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
0130014 00133Estonia► SubscribePRODUCT NAME: DEGLUDEKINSULIIN/ASPARTINSULIIN;REG NO/DATE: K(2013)368 (LOPLIK) 23.01.2013
2004005Lithuania► SubscribePRODUCT NAME: INSULIN DETEMIR
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
2107069/02Switzerland► SubscribePRODUCT NAME: INSULIN DEGLUDEC + INSULIN ASPART; REGISTRATION NO/DATE: SWISSMEDIC 62648 12.09.2013
2Finland► Subscribe
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Serving leading biopharmaceutical companies globally:

Teva
US Army
McKesson
Healthtrust
Accenture
Express Scripts
AstraZeneca
Novartis
Queensland Health
Julphar

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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