~ Buy the VICTOZA (liraglutide recombinant) Drug Profile, 2024 PDF Report in the Report Store ~

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 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

Summary for VICTOZA

International Patents:	100
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	27
Clinical Trials:	126
Patent Applications:	2,997
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 Loss of Exclusivity (LOE) Date for VICTOZA

Constraining patent/regulatory exclusivity:

8,114,833*PED

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
University of Chicago	Early Phase 1
Carmot Therapeutics, Inc.	Phase 1
Yale University	Phase 3

See all VICTOZA clinical trials

Pharmacology for VICTOZA

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

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.

This potential generic entry date is based on patent 8,114,833.

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

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	8,114,833*PED				Y
Novo Nordisk Inc	VICTOZA	liraglutide	SOLUTION;SUBCUTANEOUS	022341-001	Jan 25, 2010		RX	Yes	Yes	7,762,994*PED				Y
Novo Nordisk Inc	VICTOZA	liraglutide	SOLUTION;SUBCUTANEOUS	022341-001	Jan 25, 2010		RX	Yes	Yes	9,265,893*PED				Y

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	6,004,297
Novo Nordisk Inc	VICTOZA	liraglutide	SOLUTION;SUBCUTANEOUS	022341-001	Jan 25, 2010	RE43834
Novo Nordisk Inc	VICTOZA	liraglutide	SOLUTION;SUBCUTANEOUS	022341-001	Jan 25, 2010	RE41956*PED

International Patents for VICTOZA

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

Country	Patent Number	Title	Estimated Expiration
Taiwan	445157
Cyprus	1119723
Japan	2007513084

Supplementary Protection Certificates for VICTOZA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2209800	132014902311502	Italy		PRODUCT NAME: INSULINA DEGLUDEC/LIRAGLUTIDE(XULTOPHY); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/947, 20140918
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	122014000114	Germany		PRODUCT NAME: KOMBINATION VON INSULIN DEGLUDEC UND LIRAGLUTIDE; REGISTRATION NO/DATE: EU/1/14/947 20140918

VICTOZA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Victoza (Liraglutide)

Introduction

Victoza, also known as liraglutide, is a medication developed by Novo Nordisk, primarily used to manage blood sugar levels in patients with type 2 diabetes. It also has applications in reducing the risk of major adverse cardiovascular events. Here, we delve into the market dynamics and financial trajectory of Victoza.

Market Position and Growth

Current Market Standing

Victoza is a key player in the diabetes treatment market. It is expected to register one of the highest growth rates among diabetes medications, with a forecasted growth rate of over 4.21% over the forecast period[1].

Usage and Indications

Victoza is used in conjunction with diet and exercise to control blood sugar levels in adults and children 10 years of age and older with type 2 diabetes. It is also indicated to reduce the risk of heart attacks, strokes, or mortality in adults with type 2 diabetes and established cardiovascular disease[1].

Financial Performance

Revenue and Sales

Novo Nordisk's financial reports indicate significant revenue growth driven by Victoza. In 2023, the company reported net sales of DKK 232.261 billion, with a substantial portion attributed to its diabetes and obesity treatments, including Victoza[5].

Price Increases and Revenue Impact

From 2011 to 2017, Novo Nordisk increased the net price of Victoza by more than 32%, contributing to revenue growth. Despite this, the majority of Victoza's revenue growth came from increased prescribing volume rather than price hikes. The price increases added approximately $1.9 billion to the drug's revenue over a decade[4].

Research and Development (R&D) Impact

R&D Spending

The revenue generated from Victoza has contributed to Novo Nordisk's R&D spending. However, an analysis suggests that if the price of Victoza had remained flat since 2011, the impact on R&D spending would have been negligible, resulting in only 0.03 fewer drugs developed. This indicates that profit growth from price hikes on established drugs like Victoza does not significantly drive innovation in new drug development[4].

R&D Costs

In 2023, Novo Nordisk's R&D costs increased to DKK 32.443 billion, reflecting the company's commitment to developing new treatments. This expenditure is crucial for maintaining a robust pipeline of innovative diabetes and obesity treatments[5].

Market Dynamics and Trends

Competitive Landscape

The diabetes treatment market is highly competitive, with other major players including treatments like Ozempic (semaglutide) from the same company. The market is seeing a shift with new therapies and increased focus on cardiovascular outcomes, which is a key area where Victoza has shown significant benefits[4].

Patient and Payer Dynamics

There is a growing trend of patients paying out-of-pocket for obesity medications, including those related to Victoza. In Europe, for example, 80% of Wegovy (another Novo Nordisk product) sales were paid for out-of-pocket, indicating a willingness among patients to invest in their health[3].

Regulatory and Cost-Effectiveness Considerations

For wider and more equitable access to treatments like Victoza, positive cardiovascular outcomes data and cost-effectiveness assessments by health technology assessment (HTA) bodies are crucial. These factors influence drug prices and reimbursement policies, impacting the financial trajectory of the drug[3].

Future Outlook

Sales and Profit Projections

Novo Nordisk projects strong sales and operating profit growth for 2024, with sales expected to grow by 18-26% at constant exchange rates (CER) and operating profit by 21-29% at CER. This growth is driven by the continued success of its diabetes and obesity treatments, including Victoza[5].

Strategic Aspirations

The company is focused on reaching more patients, expanding its pipeline, and increasing production capacity. These strategic aspirations are expected to further solidify Victoza's position in the market and drive future financial performance[5].

Key Takeaways

• Growth Rate: Victoza is expected to register a high growth rate of over 4.21% in the forecast period.
• Revenue Contribution: Significant revenue growth for Novo Nordisk is attributed to Victoza and other diabetes treatments.
• R&D Impact: Price increases on Victoza have a negligible impact on R&D spending and new drug development.
• Market Trends: Growing patient willingness to pay out-of-pocket for obesity and diabetes treatments.
• Future Outlook: Strong sales and profit growth projected for 2024, driven by continued success of diabetes and obesity treatments.

FAQs

What is Victoza used for?

Victoza (liraglutide) is used to control blood sugar levels in adults and children 10 years of age and older with type 2 diabetes, and to reduce the risk of heart attacks, strokes, or mortality in adults with type 2 diabetes and established cardiovascular disease[1].

How has the price of Victoza impacted its revenue?

The price of Victoza was increased by more than 32% from 2011 to 2017, contributing approximately $1.9 billion to its revenue over the decade. However, most of the revenue growth came from increased prescribing volume rather than price hikes[4].

What is the impact of Victoza's revenue on Novo Nordisk's R&D spending?

The revenue generated from Victoza's price increases has a negligible impact on Novo Nordisk's R&D spending, resulting in only 0.03 fewer drugs developed if prices had remained flat[4].

How does the market dynamics affect Victoza's financial trajectory?

The market dynamics, including patient willingness to pay out-of-pocket and the need for positive cardiovascular outcomes data, influence the financial trajectory of Victoza. These factors impact drug prices and reimbursement policies, affecting the drug's overall financial performance[3].

What are Novo Nordisk's projections for 2024?

Novo Nordisk projects sales growth of 18-26% at CER and operating profit growth of 21-29% at CER for 2024, driven by the continued success of its diabetes and obesity treatments, including Victoza[5].

Sources

1. Mordor Intelligence - Liraglutide Market Trends
2. Novo Nordisk - Financial report for the period 1 January 2021 to 31 December 2021
3. IQVIA - 2024: The obesity market's inflection point?
4. FREOPP - The Impact of Novo Nordisk's Price Increases for Victoza
5. Novo Nordisk - Financial report for the period 1 January 2023 to 31 December 2023