VICTOZA Drug Patent Profile

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

Summary for VICTOZA

International Patents:	197
US Patents:	7
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	22
Clinical Trials:	124
Patent Applications:	4,827
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for VICTOZA
Drug Sales Revenues:	Drug sales revenues for VICTOZA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VICTOZA
What excipients (inactive ingredients) are in VICTOZA?	VICTOZA excipients list
DailyMed Link:	VICTOZA at DailyMed

See drug prices for VICTOZA

See drug sales revenues for VICTOZA

DrugPatentWatch^® Estimated Generic Entry Opportunity Date for VICTOZA

NDA:

022341

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

Sponsor	Phase
Yale University	Phase 3
Biolingus	Phase 1/Phase 2
Chinese University of Hong Kong	Phase 1/Phase 2

See all VICTOZA clinical trials

Pharmacology for VICTOZA

Drug Class	GLP-1 Receptor Agonist
Mechanism of Action	Glucagon-like Peptide-1 (GLP-1) Agonists

Anatomical Therapeutic Chemical (ATC) Classes for VICTOZA

A10BJ	Glucagon-like peptide-1 (GLP-1) analogues
A10B	BLOOD GLUCOSE LOWERING DRUGS, EXCL. INSULINS
A10	DRUGS USED IN DIABETES
A	Alimentary tract and metabolism

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.

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

FDA Regulatory Exclusivity protecting VICTOZA

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					Y
Novo Nordisk Inc	VICTOZA	liraglutide recombinant	SOLUTION;SUBCUTANEOUS	022341-001	Jan 25, 2010		RX	Yes	Yes					Y
Novo Nordisk Inc	VICTOZA	liraglutide recombinant	SOLUTION;SUBCUTANEOUS	022341-001	Jan 25, 2010		RX	Yes	Yes					Y
Novo Nordisk Inc	VICTOZA	liraglutide recombinant	SOLUTION;SUBCUTANEOUS	022341-001	Jan 25, 2010		RX	Yes	Yes
Novo Nordisk Inc	VICTOZA	liraglutide recombinant	SOLUTION;SUBCUTANEOUS	022341-001	Jan 25, 2010		RX	Yes	Yes					Y

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
Novo Nordisk Inc	VICTOZA	liraglutide recombinant	SOLUTION;SUBCUTANEOUS	022341-001	Jan 25, 2010
Novo Nordisk Inc	VICTOZA	liraglutide recombinant	SOLUTION;SUBCUTANEOUS	022341-001	Jan 25, 2010
Novo Nordisk Inc	VICTOZA	liraglutide recombinant	SOLUTION;SUBCUTANEOUS	022341-001	Jan 25, 2010
Novo Nordisk Inc	VICTOZA	liraglutide recombinant	SOLUTION;SUBCUTANEOUS	022341-001	Jan 25, 2010

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

Brazil

Canada

China

Cyprus

Denmark

European Patent Office

Hong Kong

Hungary

Japan

Mexico

Poland

Portugal

Russian Federation

Slovenia

South Korea

Spain

Turkey

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
Chile	2018002515	Liraglutida en afecciones cardiovasculares.
South Africa	9901571
Russian Federation	2254878	УСТРОЙСТВО ДЛЯ ИНЪЕКЦИЙ С ОГРАНИЧИТЕЛЕМ ДЛЯ УСТАНОВКИ ДОЗ (APPARATUS FOR INJECTIONS WITH DOSE SETTING RESTRICTOR)
Germany	69942305

Supplementary Protection Certificates for VICTOZA

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