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Last Updated: October 31, 2024

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VICTOZA Drug Patent Profile


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When do Victoza patents expire, and when can generic versions of Victoza launch?

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

This drug has one hundred patent family members in twenty-nine countries.

The generic ingredient in VICTOZA is liraglutide. There are seven drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the liraglutide 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 2021 were $3.4bn, indicating a strong incentive for generic entry (peak sales were $5.6bn in 2019).

There have been twenty 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.

There is one tentative approval for the generic drug (liraglutide), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

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Drug patent expirations by year for VICTOZA
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Drug Sales Revenue Trends for VICTOZA

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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
University of ChicagoEarly Phase 1
Carmot Therapeutics, Inc.Phase 1
Yale UniversityPhase 3

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 18 mg/3 mL prefilled syringe 022341 1 2016-12-12

US Patents and Regulatory Information for VICTOZA

VICTOZA is protected by four US patents.

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

This potential generic entry date is based on patent ⤷  Sign Up.

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

Needle mounting system and a method for mounting a needle assembly
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

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

Injection button
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Liraglutide in cardiovascular conditions
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

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 SOLUTION;SUBCUTANEOUS 022341-001 Jan 25, 2010 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Novo Nordisk Inc VICTOZA liraglutide SOLUTION;SUBCUTANEOUS 022341-001 Jan 25, 2010 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Novo Nordisk Inc VICTOZA liraglutide SOLUTION;SUBCUTANEOUS 022341-001 Jan 25, 2010 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Novo Nordisk Inc VICTOZA liraglutide SOLUTION;SUBCUTANEOUS 022341-001 Jan 25, 2010 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>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 SOLUTION;SUBCUTANEOUS 022341-001 Jan 25, 2010 ⤷  Sign Up ⤷  Sign Up
Novo Nordisk Inc VICTOZA liraglutide SOLUTION;SUBCUTANEOUS 022341-001 Jan 25, 2010 ⤷  Sign Up ⤷  Sign Up
Novo Nordisk Inc VICTOZA liraglutide SOLUTION;SUBCUTANEOUS 022341-001 Jan 25, 2010 ⤷  Sign Up ⤷  Sign Up
Novo Nordisk Inc VICTOZA liraglutide SOLUTION;SUBCUTANEOUS 022341-001 Jan 25, 2010 ⤷  Sign Up ⤷  Sign Up
Novo Nordisk Inc VICTOZA liraglutide SOLUTION;SUBCUTANEOUS 022341-001 Jan 25, 2010 ⤷  Sign Up ⤷  Sign Up
Novo Nordisk Inc VICTOZA liraglutide SOLUTION;SUBCUTANEOUS 022341-001 Jan 25, 2010 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for VICTOZA

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

Country Patent Number Title Estimated Expiration
Germany 69900026 ⤷  Sign Up
Australia 6820500 ⤷  Sign Up
Japan 2012188424 PROPYLENE GLYCOL-CONTAINING PEPTIDE FORMULATION OPTIMAL FOR PRODUCTION AND USE IN INJECTION DEVICE ⤷  Sign Up
Turkey 201906789 ⤷  Sign Up
China 108778317 用于心血管病况的利拉鲁肽 (LIRAGLUTIDE IN CARDIOVASCULAR CONDITIONS) ⤷  Sign Up
Ukraine 72181 Translated By PlajПРОИЗВОДНЫЕ ГЛЮКАГОНООБРАЗНОГО ПЕПТИДА-1;ПОХІДНА ГЛЮКАГОНОПОДІБНОГО ПЕПТИДУ-1 (ВАРІАНТИ), ФАРМАЦЕВТИЧНА КОМПОЗИЦІЯ ТА СПОСІБ ОДЕРЖАННЯ ЛІКУВАЛЬНОГО ЗАСОБУ (ВАРІАНТИ), СПОСІБ ЛІКУВАННЯ ДІАБЕТУ (ВАРІАНТИ) І ОЖИРІННЯ (DERIVATIVES OF GLUCANOLIKE PEPTIDE-1) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for VICTOZA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2209800 SPC/GB14/079 United Kingdom ⤷  Sign Up 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
2209800 132014902311502 Italy ⤷  Sign Up PRODUCT NAME: INSULINA DEGLUDEC/LIRAGLUTIDE(XULTOPHY); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/947, 20140918
0944648 CA 2009 00041 Denmark ⤷  Sign Up
0944648 C00944648/01 Switzerland ⤷  Sign Up PRODUCT NAME: LIRAGLUTID; REGISTRATION NO/DATE: SWISSMEDIC 59329 11.12.2009
0944648 09C0054 France ⤷  Sign Up 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 SPC/GB09/058 United Kingdom ⤷  Sign Up PRODUCT NAME: LIRAGLUTIDE; REGISTERED: UK EU/1/09/529/001 20090630
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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