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VICTOZA Drug 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 ten patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and forty-five patent family members in thirty-one 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.

US ANDA Litigation and Generic Entry Outlook for Victoza

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

Annual sales in 2017 were $4.0bn, indicating a strong incentive for generic entry.

There have been three 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.

Summary for VICTOZA

International Patents:	245
US Patents:	10
Applicants:	1
NDAs:	1
Suppliers / Packagers:	2
Bulk Api Vendors:	14
Clinical Trials:	105
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
DailyMed Link:	VICTOZA at DailyMed

See drug prices for VICTOZA

See drug sales revenues for VICTOZA

Recent Clinical Trials for VICTOZA

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

Sponsor	Phase
Universitaire Ziekenhuizen Leuven	Phase 4
Second Affiliated Hospital, School of Medicine, Zhejiang University	Phase 4
First Affiliated Hospital of Jinan University	Phase 3

See all VICTOZA clinical trials

Recent Litigation for VICTOZA

Identify potential future generic entrants

District Court Litigation

Case Name	Date
Novo Nordisk Inc. v. Teva Pharmaceuticals USA, Inc.	2017-03-03
SMITH v. NOVO NORDISK INC.	2016-08-08
Novo Nordisk A/S v. Sanofi-Aventis	2005-09-02

See all VICTOZA litigation

Pharmacology for VICTOZA

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

Synonyms for VICTOZA

204656-20-2

AKOS037435224

Arg34Lys26-(N-epsilon-(gamma-Glu(N-alpha-hexadecanoyl)))-GLP-1(7-37)

CHEBI:71193

EX-A2418

GTPL1133

H-His-Ala-Glu-Gly-Thr-Phe-Thr-Ser-Asp-Val-Ser-Ser-Tyr-Leu-Glu-Gly-Gln-Ala-Ala-Lys(|A-Glu-palmitoyl)-Glu-Phe-Ile-Ala-Trp-Leu-Val-Arg-Gly-Arg-Gly-OH

HSDB 8205

Liraglutida

Liraglutida [INN-Spanish]

Liraglutide

Liraglutide [USAN:INN:BAN:JAN]

Liraglutidum

Liraglutidum [INN-Latin]

MolPort-044-560-360

N(sup 26)-(Hexadecanoyl-gamma-glutamyle)-(34-arginine)GLP-1-(7-37)-peptide

N26-(Hexadecanoyl-gamma-glutamyle)-(34-arginine)GLP-1-(7-37)-peptide

N26-(Hexadecanoyl-gamma-glutamyle)-(34-arginine)glucagon-like-peptide-1-(7-37)-peptide

NN 2211

NN-2211

NN2211

NNC 90-1170

s8256

Saxenda

SCHEMBL20511941

Paragraph IV (Patent) Challenges for VICTOZA

Tradename	Dosage	Ingredient	NDA	Submissiondate
VICTOZA	SOLUTION;SUBCUTANEOUS	liraglutide recombinant	022341	2016-12-12

US Patents and Regulatory Information for 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
Novo Nordisk Inc	VICTOZA	liraglutide recombinant	SOLUTION;SUBCUTANEOUS	022341-001	Jan 25, 2010		RX	Yes	Yes

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

Country	Patent Number	Estimated Expiration
Japan	5562510
Germany	602008002896
Turkey	201906789
Japan	2002504518
European Patent Office	2109474
World Intellectual Property Organization (WIPO)	2004004812

Supplementary Protection Certificates for VICTOZA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2209800	122014000114	Germany		PRODUCT NAME: KOMBINATION VON INSULIN DEGLUDEC UND LIRAGLUTIDE; REGISTRATION NO/DATE: EU/1/14/947 20140918
2209800	14C0085	France		PRODUCT NAME: LIRAGLUTIDE ET INSULINE DEGLUDEC; REGISTRATION NO/DATE: EU/1/14/947 20140918
0944648	SPC/GB09/058	United Kingdom		PRODUCT NAME: LIRAGLUTIDE; REGISTERED: UK EU/1/09/529/001 20090630
2209800	SPC/GB14/079	United Kingdom		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	1490067-4	Sweden		PRODUCT NAME: COMBINATION OF INSULIN DEGLUDEC AND LIRAGLUTIDE; REG. NO/DATE: EU/1/14/974 20140918
0944648	SPC034/2009	Ireland		SPC034/2009: 20101001, EXPIRES: 20220821