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Last Updated: October 3, 2023

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 six patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and eighty-six 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 sixteen 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 Loss of Exclusivity (LOE) 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
Carmot Therapeutics, Inc.Phase 1
Yale UniversityPhase 3
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 six US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of VICTOZA is ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Needle mounting system and a method for mounting a needle assembly
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Propylene glycol-containing peptide formulations which are optimal for production and for use in injection devices
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Needle mounting system and a method for mounting a needle assembly
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Injection button
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

Liraglutide in cardiovascular conditions
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Novo Nordisk Inc VICTOZA liraglutide recombinant SOLUTION;SUBCUTANEOUS 022341-001 Jan 25, 2010 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Novo Nordisk Inc VICTOZA liraglutide recombinant SOLUTION;SUBCUTANEOUS 022341-001 Jan 25, 2010 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Novo Nordisk Inc VICTOZA liraglutide recombinant SOLUTION;SUBCUTANEOUS 022341-001 Jan 25, 2010 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Novo Nordisk Inc VICTOZA liraglutide recombinant SOLUTION;SUBCUTANEOUS 022341-001 Jan 25, 2010 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Novo Nordisk Inc VICTOZA liraglutide recombinant SOLUTION;SUBCUTANEOUS 022341-001 Jan 25, 2010 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>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 ⤷  Try a Trial ⤷  Try a Trial
Novo Nordisk Inc VICTOZA liraglutide recombinant SOLUTION;SUBCUTANEOUS 022341-001 Jan 25, 2010 ⤷  Try a Trial ⤷  Try a Trial
Novo Nordisk Inc VICTOZA liraglutide recombinant SOLUTION;SUBCUTANEOUS 022341-001 Jan 25, 2010 ⤷  Try a Trial ⤷  Try a Trial
Novo Nordisk Inc VICTOZA liraglutide recombinant SOLUTION;SUBCUTANEOUS 022341-001 Jan 25, 2010 ⤷  Try a Trial ⤷  Try a Trial
Novo Nordisk Inc VICTOZA liraglutide recombinant SOLUTION;SUBCUTANEOUS 022341-001 Jan 25, 2010 ⤷  Try a Trial ⤷  Try a Trial
Novo Nordisk Inc VICTOZA liraglutide recombinant SOLUTION;SUBCUTANEOUS 022341-001 Jan 25, 2010 ⤷  Try a Trial ⤷  Try a Trial
>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: ⤷  Try a Trial

Brazil

Patent: 0416743
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 45034
Estimated Expiration: ⤷  Try a Trial

China

Patent: 82356
Estimated Expiration: ⤷  Try a Trial

Patent: 2784386
Estimated Expiration: ⤷  Try a Trial

Patent: 4826116
Estimated Expiration: ⤷  Try a Trial

Patent: 3304250
Estimated Expiration: ⤷  Try a Trial

Cyprus

Patent: 19723
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 87019
Estimated Expiration: ⤷  Try a Trial

Patent: 00721
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 87019
Estimated Expiration: ⤷  Try a Trial

Patent: 94656
Estimated Expiration: ⤷  Try a Trial

Patent: 00721
Estimated Expiration: ⤷  Try a Trial

Hong Kong

Patent: 46683
Estimated Expiration: ⤷  Try a Trial

Hungary

Patent: 38395
Estimated Expiration: ⤷  Try a Trial

Patent: 43210
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 58655
Estimated Expiration: ⤷  Try a Trial

Patent: 70373
Estimated Expiration: ⤷  Try a Trial

Patent: 07513084
Estimated Expiration: ⤷  Try a Trial

Patent: 12188424
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 06005581
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 87019
Estimated Expiration: ⤷  Try a Trial

Patent: 00721
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 87019
Estimated Expiration: ⤷  Try a Trial

Patent: 00721
Estimated Expiration: ⤷  Try a Trial

Russian Federation

Patent: 21238
Estimated Expiration: ⤷  Try a Trial

Patent: 06116414
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 87019
Estimated Expiration: ⤷  Try a Trial

Patent: 00721
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 1243648
Estimated Expiration: ⤷  Try a Trial

Patent: 060100428
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 60320
Estimated Expiration: ⤷  Try a Trial

Patent: 27854
Estimated Expiration: ⤷  Try a Trial

Turkey

Patent: 1906789
Estimated Expiration: ⤷  Try a Trial

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
European Patent Office 1056774 ⤷  Try a Trial
China 1183975 ⤷  Try a Trial
Portugal 1687019 ⤷  Try a Trial
Austria 466026 ⤷  Try a Trial
Russian Federation 2421238 ПЕПТИДНАЯ КОМПОЗИЦИЯ, СОДЕРЖАЩАЯ ПРОПИЛЕНГЛИКОЛЬ, ЯВЛЯЮЩАЯСЯ ОПТИМАЛЬНОЙ ДЛЯ ИЗГОТОВЛЕНИЯ И ПРИМЕНЕНИЯ В ИНЪЕКЦИОННЫХ УСТРОЙСТВАХ (PEPTIDE COMPOSITION CONTAINING PROPYLENE GLYCOL OPTIMAL FOR MANUFACTURING AND APPLICATION IN INJECTION DEVICES) ⤷  Try a Trial
Poland 2109474 ⤷  Try a Trial
China 100502968 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for VICTOZA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0944648 09C0054 France ⤷  Try a Trial PRODUCT 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
0944648 C00944648/01 Switzerland ⤷  Try a Trial PRODUCT NAME: LIRAGLUTID; REGISTRATION NO/DATE: SWISSMEDIC 59329 11.12.2009
2209800 SPC/GB14/079 United Kingdom ⤷  Try a Trial PRODUCT NAME: COMBINATION OF INSULIN DEGLUDEC, OR PHARMACEUTICALLY ACCEPTABLE SOLVATES, HYDRATES, OR SALTS THEREOF, AND LIRAGLUTIDE, OR PHARMACEUTICALLY ACCEPTABLE SOLVATES, HYDRATES, OR SALTS THEREOF; REGISTERED: CH 65041 20140912; UK EU/1/14/947 20140922
0944648 SPC034/2009 Ireland ⤷  Try a Trial SPC034/2009: 20101001, EXPIRES: 20220821
2209800 14C0085 France ⤷  Try a Trial PRODUCT NAME: LIRAGLUTIDE ET INSULINE DEGLUDEC; REGISTRATION NO/DATE: EU/1/14/947 20140918
2209800 C300698 Netherlands ⤷  Try a Trial PRODUCT NAME: INSULINE DEGLUDEC EN LIRAGLUTIDE; REGISTRATION NO/DATE: EU/1/14/94765041 2014120918
2209800 122014000114 Germany ⤷  Try a Trial PRODUCT NAME: KOMBINATION VON INSULIN DEGLUDEC UND LIRAGLUTIDE; REGISTRATION NO/DATE: EU/1/14/947 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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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.