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Last Updated: August 15, 2022

VICTOZA Drug Patent Profile


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When do Victoza patents expire, and what generic alternatives are available?

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

This drug has one hundred and ninety-seven patent family members in thirty-two countries.

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

DrugPatentWatch® Generic Entry Outlook for Victoza

Victoza was eligible for patent challenges on January 25, 2014.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 13, 2026. This may change due to patent challenges or generic licensing.

Annual sales in 2019 were $5.6bn, indicating a strong incentive for generic entry.

There have been thirteen patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for VICTOZA
Drug Prices for VICTOZA

See drug prices for VICTOZA

Drug Sales Revenue Trends for VICTOZA

See drug sales revenues for VICTOZA

DrugPatentWatch® Estimated Generic Entry Opportunity Date for VICTOZA
Generic Entry Date for VICTOZA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SOLUTION;SUBCUTANEOUS

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for VICTOZA

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Yale UniversityPhase 3
BiolingusPhase 1/Phase 2
Chinese University of Hong KongPhase 1/Phase 2

See all VICTOZA clinical trials

Pharmacology for VICTOZA
Paragraph IV (Patent) Challenges for VICTOZA
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
VICTOZA Injection liraglutide recombinant 18 mg/3 mL prefilled syringe 022341 1 2016-12-12

US Patents and Regulatory Information for VICTOZA

VICTOZA is protected by seven US patents and two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of VICTOZA is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting VICTOZA

Derivatives of GLP-1 analogs
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Needle mounting system and a method for mounting a needle assembly
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Propylene glycol-containing peptide formulations which are optimal for production and for use in injection devices
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Needle mounting system and a method for mounting a needle assembly
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Stable formulation of modified GLP-1
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Injection button
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Liraglutide in cardiovascular conditions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

FDA Regulatory Exclusivity protecting VICTOZA

NEW PATIENT POPULATION
Exclusivity Expiration: See Plans and Pricing

PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: See Plans and Pricing

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 VICTOZA liraglutide recombinant SOLUTION;SUBCUTANEOUS 022341-001 Jan 25, 2010 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Novo Nordisk Inc VICTOZA liraglutide recombinant SOLUTION;SUBCUTANEOUS 022341-001 Jan 25, 2010 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Novo Nordisk Inc VICTOZA liraglutide recombinant SOLUTION;SUBCUTANEOUS 022341-001 Jan 25, 2010 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Novo Nordisk Inc VICTOZA liraglutide recombinant SOLUTION;SUBCUTANEOUS 022341-001 Jan 25, 2010 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Novo Nordisk Inc VICTOZA liraglutide recombinant SOLUTION;SUBCUTANEOUS 022341-001 Jan 25, 2010 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for VICTOZA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novo Nordisk Inc VICTOZA liraglutide recombinant SOLUTION;SUBCUTANEOUS 022341-001 Jan 25, 2010 See Plans and Pricing See Plans and Pricing
Novo Nordisk Inc VICTOZA liraglutide recombinant SOLUTION;SUBCUTANEOUS 022341-001 Jan 25, 2010 See Plans and Pricing See Plans and Pricing
Novo Nordisk Inc VICTOZA liraglutide recombinant SOLUTION;SUBCUTANEOUS 022341-001 Jan 25, 2010 See Plans and Pricing See Plans and Pricing
Novo Nordisk Inc VICTOZA liraglutide recombinant SOLUTION;SUBCUTANEOUS 022341-001 Jan 25, 2010 See Plans and Pricing See Plans and Pricing
Novo Nordisk Inc VICTOZA liraglutide recombinant SOLUTION;SUBCUTANEOUS 022341-001 Jan 25, 2010 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for VICTOZA

When does loss-of-exclusivity occur for VICTOZA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 04290862
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0416743
Estimated Expiration: See Plans and Pricing

Canada

Patent: 45034
Estimated Expiration: See Plans and Pricing

China

Patent: 82356
Estimated Expiration: See Plans and Pricing

Patent: 2784386
Estimated Expiration: See Plans and Pricing

Patent: 4826116
Estimated Expiration: See Plans and Pricing

Patent: 3304250
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 19723
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 87019
Estimated Expiration: See Plans and Pricing

Patent: 00721
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 87019
Estimated Expiration: See Plans and Pricing

Patent: 94656
Estimated Expiration: See Plans and Pricing

Patent: 00721
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 46683
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 38395
Estimated Expiration: See Plans and Pricing

Patent: 43210
Estimated Expiration: See Plans and Pricing

Japan

Patent: 58655
Estimated Expiration: See Plans and Pricing

Patent: 70373
Estimated Expiration: See Plans and Pricing

Patent: 07513084
Estimated Expiration: See Plans and Pricing

Patent: 12188424
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 06005581
Estimated Expiration: See Plans and Pricing

Poland

Patent: 87019
Estimated Expiration: See Plans and Pricing

Patent: 00721
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 87019
Estimated Expiration: See Plans and Pricing

Patent: 00721
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 21238
Estimated Expiration: See Plans and Pricing

Patent: 06116414
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 87019
Estimated Expiration: See Plans and Pricing

Patent: 00721
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1243648
Estimated Expiration: See Plans and Pricing

Patent: 060100428
Estimated Expiration: See Plans and Pricing

Spain

Patent: 60320
Estimated Expiration: See Plans and Pricing

Patent: 27854
Estimated Expiration: See Plans and Pricing

Turkey

Patent: 1906789
Estimated Expiration: See Plans and Pricing

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering VICTOZA around the world.

Country Patent Number Title Estimated Expiration
Germany 69942307 See Plans and Pricing
Chile 2018002515 Liraglutida en afecciones cardiovasculares. See Plans and Pricing
South Africa 9901571 See Plans and Pricing
Russian Federation 2254878 УСТРОЙСТВО ДЛЯ ИНЪЕКЦИЙ С ОГРАНИЧИТЕЛЕМ ДЛЯ УСТАНОВКИ ДОЗ (APPARATUS FOR INJECTIONS WITH DOSE SETTING RESTRICTOR) See Plans and Pricing
Germany 69942305 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for VICTOZA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0944648 C00944648/01 Switzerland See Plans and Pricing PRODUCT NAME: LIRAGLUTID; REGISTRATION NO/DATE: SWISSMEDIC 59329 11.12.2009
0944648 SPC034/2009 Ireland See Plans and Pricing SPC034/2009: 20101001, EXPIRES: 20220821
2597103 2017/015 Ireland See Plans and Pricing PRODUCT NAME: COMBINATION OF INSULIN DEGLUDEC AND LIRAGLUTIDE; NAT REGISTRATION NO/DATE: EU/1/14/947 20140918; FIRST REGISTRATION NO/DATE: 65041 20140912
0944648 SPC/GB09/058 United Kingdom See Plans and Pricing PRODUCT NAME: LIRAGLUTIDE; REGISTERED: UK EU/1/09/529/001 20090630
2209800 1490067-4 Sweden See Plans and Pricing PRODUCT NAME: COMBINATION OF INSULIN DEGLUDEC AND LIRAGLUTIDE; REG. NO/DATE: EU/1/14/974 20140918
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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AstraZeneca

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 verification 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.