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Serving leading biopharmaceutical companies globally:

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Generated: December 13, 2017

DrugPatentWatch Database Preview

Insulin degludec; liraglutide - Generic Drug Details

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

Insulin degludec; liraglutide
is the generic ingredient in one branded drug marketed by Novo Nordisk Inc and is included in one NDA. There are seventeen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Insulin degludec; liraglutide has two hundred and fifty-two patent family members in twenty-seven countries and fifty-four supplementary protection certificates in fifteen countries.

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

Summary for insulin degludec; liraglutide

Pharmacology for insulin degludec; liraglutide

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Novo Nordisk IncXULTOPHY 100/3.6insulin degludec; liraglutideSOLUTION;SUBCUTANEOUS208583-001Nov 21, 2016RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Novo Nordisk IncXULTOPHY 100/3.6insulin degludec; liraglutideSOLUTION;SUBCUTANEOUS208583-001Nov 21, 2016RXYesYes► Subscribe► Subscribe► SubscribeYY► Subscribe
Novo Nordisk IncXULTOPHY 100/3.6insulin degludec; liraglutideSOLUTION;SUBCUTANEOUS208583-001Nov 21, 2016RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Novo Nordisk IncXULTOPHY 100/3.6insulin degludec; liraglutideSOLUTION;SUBCUTANEOUS208583-001Nov 21, 2016RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Novo Nordisk IncXULTOPHY 100/3.6insulin degludec; liraglutideSOLUTION;SUBCUTANEOUS208583-001Nov 21, 2016RXYesYes► Subscribe► Subscribe► SubscribeYY► Subscribe
Novo Nordisk IncXULTOPHY 100/3.6insulin degludec; liraglutideSOLUTION;SUBCUTANEOUS208583-001Nov 21, 2016RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Novo Nordisk IncXULTOPHY 100/3.6insulin degludec; liraglutideSOLUTION;SUBCUTANEOUS208583-001Nov 21, 2016RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Novo Nordisk IncXULTOPHY 100/3.6insulin degludec; liraglutideSOLUTION;SUBCUTANEOUS208583-001Nov 21, 2016RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Novo Nordisk IncXULTOPHY 100/3.6insulin degludec; liraglutideSOLUTION;SUBCUTANEOUS208583-001Nov 21, 2016RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Novo Nordisk IncXULTOPHY 100/3.6insulin degludec; liraglutideSOLUTION;SUBCUTANEOUS208583-001Nov 21, 2016RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
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Expired Orange Book Patents for Generic Ingredient: insulin degludec; liraglutide

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novo Nordisk IncXULTOPHY 100/3.6insulin degludec; liraglutideSOLUTION;SUBCUTANEOUS208583-001Nov 21, 2016► Subscribe► Subscribe
Novo Nordisk IncXULTOPHY 100/3.6insulin degludec; liraglutideSOLUTION;SUBCUTANEOUS208583-001Nov 21, 2016► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: insulin degludec; liraglutide

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
8,096,978Automatic injection device with a top release mechanism► Subscribe
8,097,698Derivatives of GLP-1 analogs► Subscribe
8,828,923Insulin derivatives► Subscribe
7,226,990Extendin derivatives► Subscribe
6,384,016 Stabilized aqueous peptide solutions► 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; liraglutide

Country Document Number Estimated Expiration
Japan5185620► Subscribe
Canada2264243► Subscribe
Luxembourg92226► Subscribe
Russian Federation2007127537► Subscribe
Denmark2107069► Subscribe
Spain2394556► Subscribe
Russian Federation2007126416► Subscribe
European Patent Office1061946► Subscribe
Australia2005298944► Subscribe
Israel189136► 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; LIRAGLUTIDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00021Netherlands► SubscribePRODUCT NAME: INSULINE ASPART EN GEKRISTALLISEERD PROTAMINE-INSULINE ASPART; NAT. REGISTRATION NO/DATE: EU/1/00/142/001 20000801; FIRST REGISTRATION: 55414015541502 2000230623
0880Netherlands► SubscribePRODUCT NAME: SNELWERKENDE INSULIN ASPART; REGISTRATION NO/DATE: EU/1/16/1160 20170109
91022-0Sweden► SubscribePRODUCT NAME: N EPSILONB29 MYRISTOYL- ELLER N EPSILONB29 TETRADEKANOYL-DES(B30) HUMANT INSULIN
2Finland► Subscribe
C0085France► SubscribePRODUCT NAME: LIRAGLUTIDE ET INSULINE DEGLUDEC; REGISTRATION NO/DATE: EU/1/14/947 20140918
2013 00033Denmark► Subscribe
2/2005Austria► SubscribePRODUCT NAME: INSULIN GLULISINE
213Luxembourg► SubscribePRODUCT NAME: INSULINE DEGLUDEC SOUS TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE
90036-0Sweden► SubscribePRODUCT NAME: KOMBINATION AV INSULIN DEGLUDEK OCH INSULIN ASPART; REG. NO/DATE: EU/1/12/806/001 20130121
/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
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Serving leading biopharmaceutical companies globally:

Cerilliant
QuintilesIMS
Dow
AstraZeneca
Mallinckrodt
Fuji
Julphar
Argus Health
Harvard Business School
Covington

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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