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Generated: December 16, 2017

DrugPatentWatch Database Preview

Liraglutide recombinant - Generic Drug Details

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What are the generic sources for liraglutide recombinant and what is the scope of liraglutide recombinant freedom to operate?

Liraglutide recombinant
is the generic ingredient in two branded drugs marketed by Novo Nordisk Inc and is included in two NDAs. There are twenty patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Liraglutide recombinant has two hundred and eighty-seven patent family members in twenty-six countries and ten supplementary protection certificates in eight countries.

There are six drug master file entries for liraglutide recombinant. One supplier is listed for this compound.

Pharmacology for liraglutide recombinant

Medical Subject Heading (MeSH) Categories for liraglutide recombinant

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novo Nordisk IncSAXENDAliraglutide recombinantSOLUTION;SUBCUTANEOUS206321-001Dec 23, 2014RXYesYes► Subscribe► SubscribeY► Subscribe
Novo Nordisk IncSAXENDAliraglutide recombinantSOLUTION;SUBCUTANEOUS206321-001Dec 23, 2014RXYesYes► Subscribe► SubscribeY► Subscribe
Novo Nordisk IncSAXENDAliraglutide recombinantSOLUTION;SUBCUTANEOUS206321-001Dec 23, 2014RXYesYes► Subscribe► SubscribeY► Subscribe
Novo Nordisk IncSAXENDAliraglutide recombinantSOLUTION;SUBCUTANEOUS206321-001Dec 23, 2014RXYesYes► Subscribe► SubscribeY► Subscribe
Novo Nordisk IncSAXENDAliraglutide recombinantSOLUTION;SUBCUTANEOUS206321-001Dec 23, 2014RXYesYes► Subscribe► SubscribeY► Subscribe
Novo Nordisk IncSAXENDAliraglutide recombinantSOLUTION;SUBCUTANEOUS206321-001Dec 23, 2014RXYesYes► Subscribe► SubscribeY► Subscribe
Novo Nordisk IncVICTOZAliraglutide recombinantSOLUTION;SUBCUTANEOUS022341-001Jan 25, 2010RXYesYes► Subscribe► Subscribe► Subscribe
Novo Nordisk IncSAXENDAliraglutide recombinantSOLUTION;SUBCUTANEOUS206321-001Dec 23, 2014RXYesYes► Subscribe► SubscribeY► Subscribe
Novo Nordisk IncSAXENDAliraglutide recombinantSOLUTION;SUBCUTANEOUS206321-001Dec 23, 2014RXYesYes► Subscribe► SubscribeY► Subscribe
Novo Nordisk IncSAXENDAliraglutide recombinantSOLUTION;SUBCUTANEOUS206321-001Dec 23, 2014RXYesYes► Subscribe► SubscribeY► Subscribe
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Expired Orange Book Patents for Generic Ingredient: liraglutide recombinant

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novo Nordisk IncVICTOZAliraglutide recombinantSOLUTION;SUBCUTANEOUS022341-001Jan 25, 2010► Subscribe► Subscribe
Novo Nordisk IncVICTOZAliraglutide recombinantSOLUTION;SUBCUTANEOUS022341-001Jan 25, 2010► Subscribe► Subscribe
Novo Nordisk IncSAXENDAliraglutide recombinantSOLUTION;SUBCUTANEOUS206321-001Dec 23, 2014► Subscribe► Subscribe
Novo Nordisk IncSAXENDAliraglutide recombinantSOLUTION;SUBCUTANEOUS206321-001Dec 23, 2014► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: liraglutide recombinant

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
6,582,404 Dose setting limiter► Subscribe
7,226,990Extendin derivatives► Subscribe
7,686,786Dial-down mechanism for wind-up pen► Subscribe
8,097,698Derivatives of GLP-1 analogs► Subscribe
6,235,004 Injection syringe► Subscribe
6,384,016 Stabilized aqueous peptide solutions► Subscribe
8,357,120Injection device with torsion spring and rotatable display► 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: liraglutide recombinant

Country Document Number Estimated Expiration
Australia2005298944► Subscribe
Japan2008517233► Subscribe
China100571804► Subscribe
Japan2004535442► Subscribe
Poland331896► Subscribe
European Patent Office1351732► Subscribe
Russian Federation2007114761► Subscribe
China1277558► Subscribe
Czech Republic20001034► Subscribe
China1243578► 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: LIRAGLUTIDE RECOMBINANT

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0085France► SubscribePRODUCT NAME: LIRAGLUTIDE ET INSULINE DEGLUDEC; REGISTRATION NO/DATE: EU/1/14/947 20140918
2209800/01Switzerland► SubscribePRODUCT NAME: INSULIN DEGLUDEC + LIRAGLUTIDE; REGISTRATION NO/DATE: SWISSMEDIC 65041 12.09.2014
90067-4Sweden► SubscribePRODUCT NAME: COMBINATION OF INSULIN DEGLUDEC AND LIRAGLUTIDE; REG. NO/DATE: EU/1/14/974 20140918
00698Netherlands► SubscribePRODUCT NAME: INSULINE DEGLUDEC EN LIRAGLUTIDE; REGISTRATION NO/DATE: EU/1/14/94765041 2014120918
2014000114Germany► SubscribePRODUCT NAME: KOMBINATION VON INSULIN DEGLUDEC UND LIRAGLUTIDE; REGISTRATION NO/DATE: EU/1/14/947 20140918
0944648/01Switzerland► SubscribePRODUCT NAME: LIRAGLUTID; REGISTRATION NO/DATE: SWISSMEDIC 59329 11.12.2009
C034/2009Ireland► SubscribeSPC034/2009: 20101001, EXPIRES: 20220821
C/GB09/058United Kingdom► SubscribePRODUCT NAME: LIRAGLUTIDE; REGISTERED: UK EU/1/09/529/001 20090630
2009 00041Denmark► Subscribe
C0054France► SubscribePRODUCT NAME: LIRAGLUTIDE; REGISTRATION NO/DATE IN FRANCE: EU/1/09/529/001 DU 20090630; REGISTRATION NO/DATE AT EEC: EU/1/09/529/001 DU 20090630
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For more information try a trial or see the plans and pricing

Serving leading biopharmaceutical companies globally:

Teva
McKesson
Colorcon
Novartis
UBS
Daiichi Sankyo
Fuji
Chubb
Cipla
Express Scripts

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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