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VICTOZA Drug Profile

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Which patents cover Victoza, and what substitute generic drugs are available?

Victoza is a drug marketed by Novo Nordisk Inc and is included in one NDA. There are nine patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and eighty-five patent family members in twenty-six countries.

The generic ingredient in VICTOZA is liraglutide recombinant. There are six drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the liraglutide recombinant profile page.

Summary for Tradename: VICTOZA

Patents:9
Applicants:1
NDAs:1
Suppliers / Packagers: see list2
Clinical Trials: see list79
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:VICTOZA at DailyMed

Pharmacology for Tradename: VICTOZA

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novo Nordisk Inc
VICTOZA
liraglutide recombinant
SOLUTION;SUBCUTANEOUS022341-001Jan 25, 2010RXYesYes6,458,924► SubscribeYY ► Subscribe
Novo Nordisk Inc
VICTOZA
liraglutide recombinant
SOLUTION;SUBCUTANEOUS022341-001Jan 25, 2010RXYesYesRE41956► SubscribeY ► Subscribe
Novo Nordisk Inc
VICTOZA
liraglutide recombinant
SOLUTION;SUBCUTANEOUS022341-001Jan 25, 2010RXYesYesRE43834► SubscribeY ► Subscribe
Novo Nordisk Inc
VICTOZA
liraglutide recombinant
SOLUTION;SUBCUTANEOUS022341-001Jan 25, 2010RXYesYes6,004,297► SubscribeY ► Subscribe
Novo Nordisk Inc
VICTOZA
liraglutide recombinant
SOLUTION;SUBCUTANEOUS022341-001Jan 25, 2010RXYesYes6,268,343► SubscribeYY ► Subscribe
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Paragraph IV activity for: VICTOZA

Drugname Dosage Strength RLD Submissiondate
liraglutideInjection18 mg/3 mL prefilled syringeVictoza12/12/2016

Non-Orange Book Patents for Tradename: VICTOZA

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
6,235,004 Injection syringe► Subscribe
8,097,698Derivatives of GLP-1 analogs► Subscribe
6,384,016 Stabilized aqueous peptide solutions► Subscribe
6,582,404 Dose setting limiter► Subscribe
7,226,990Extendin derivatives► 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 Tradename: VICTOZA

Country Document Number Estimated Expiration
Austria356830► Subscribe
Norway325273► Subscribe
South Africa200201997► Subscribe
Czech Republic300837► Subscribe
South Africa9901570► 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: VICTOZA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
90067-4Sweden► SubscribePRODUCT NAME: COMBINATION OF INSULIN DEGLUDEC AND LIRAGLUTIDE; REG. NO/DATE: EU/1/14/974 20140918
C034/2009Ireland► SubscribeSPC034/2009: 20101001, EXPIRES: 20220821
C0085France► SubscribePRODUCT NAME: LIRAGLUTIDE ET INSULINE DEGLUDEC; REGISTRATION NO/DATE: EU/1/14/947 20140918
2009 00041Denmark► Subscribe
C/GB09/058United Kingdom► SubscribePRODUCT NAME: LIRAGLUTIDE; REGISTERED: UK EU/1/09/529/001 20090630
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