VICTOZA Drug Patent Profile

Which patents cover Victoza, 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 two patents protecting this drug and one Paragraph IV challenge.

This drug has sixty-three patent family members in twenty-seven countries.

The generic ingredient in VICTOZA is liraglutide. There are seven drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the liraglutide profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Victoza

A generic version of VICTOZA was approved as liraglutide by HIKMA on December 23^rd, 2024.

Summary for VICTOZA

International Patents:	63
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	46
Clinical Trials:	126
Patent Applications:	3,456
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 two 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	AP1	RX	Yes	Yes	8,114,833*PED				Y
Novo Nordisk Inc	VICTOZA	liraglutide	SOLUTION;SUBCUTANEOUS	022341-001	Jan 25, 2010	AP1	RX	Yes	Yes	9,968,659*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
Novo Nordisk Inc	VICTOZA	liraglutide	SOLUTION;SUBCUTANEOUS	022341-001	Jan 25, 2010	7,235,627
Novo Nordisk Inc	VICTOZA	liraglutide	SOLUTION;SUBCUTANEOUS	022341-001	Jan 25, 2010	6,235,004
Novo Nordisk Inc	VICTOZA	liraglutide	SOLUTION;SUBCUTANEOUS	022341-001	Jan 25, 2010	6,458,924

International Patents for VICTOZA

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

Country	Patent Number	Title	Estimated Expiration
Poland	374182	Układ do montowania igieł oraz sposób montowania zestawu igieł (A NEEDLE MOUNTING SYSTEM AND A METHOD FOR MOUNTING A NEEDLE ASSEMBLY)
China	100569798
Israel	148609	DOSE SETTING LIMITER
Taiwan	445157
China	1665558	A needle mounting system and a method for mounting a needle assembly
Morocco	43704	LIRAGLUTIDE DANS DES ÉTATS CARDIO-VASCULAIRES
Hong Kong	1246683	對於生產和用於注射裝置中是最佳的含有丙二醇的肽製劑 (PROPYLENE GLYCOL-CONTAINING PEPTIDE FORMULATIONS WHICH ARE OPTIMAL FOR PRODUCTION AND FOR USE IN INJECTION DEVICES)

Supplementary Protection Certificates for VICTOZA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2209800	C300698	Netherlands		PRODUCT NAME: INSULINE DEGLUDEC EN LIRAGLUTIDE; REGISTRATION NO/DATE: EU/1/14/94765041 2014120918
0944648	SPC034/2009	Ireland		SPC034/2009: 20101001, EXPIRES: 20220821
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
0944648	CA 2009 00041	Denmark
2209800	122014000114	Germany		PRODUCT NAME: KOMBINATION VON INSULIN DEGLUDEC UND LIRAGLUTIDE; REGISTRATION NO/DATE: EU/1/14/947 20140918
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

Market Dynamics and Financial Trajectory for VICTOZA

Last updated: December 26, 2025

Summary

VICTOZA (liraglutide) is a GLP-1 receptor agonist developed by Novo Nordisk for the treatment of type 2 diabetes mellitus (T2DM) and obesity. Since its approval by the FDA in 2010, VICTOZA has gained significant market share within the rapidly expanding GLP-1 receptor agonist segment. This analysis examines VICTOZA’s current market position, growth drivers, competitive landscape, revenue outlook, and regulatory considerations, providing a comprehensive overview for stakeholders evaluating its financial trajectory.

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What Are the Market Fundamentals for VICTOZA?

Global Prevalence of T2DM and Obesity

• Diabetes Prevalence: The International Diabetes Federation reported approximately 537 million adults with diabetes in 2021; projected to reach 643 million by 2030 [1].
• Obesity Rates: The World Obesity Federation estimates over 650 million adults were obese globally in 2016, with ongoing upward trends [2].
• Impact on VICTOZA Demand: These conditions directly influence the demand for GLP-1 receptor agonists like VICTOZA, making it a pivotal product in diabetes and obesity therapeutics.

Market Segments and Indications

Indication	Approved Age Group	Key Advantages	Market Penetration (2023)
T2DM	Adults	Glycemic control, weight loss	70% overall
Obesity (via Saxenda)	Adults (≥18)	Weight management, cardiovascular benefits	Growing sector

Note: VICTOZA operates primarily in glucose management for T2DM, whereas its related formulation, Saxenda, targets obesity.

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How Is the Competitive Landscape Shaping Up?

Major Competitors

Competitor	Key Products	Mechanism of Action	Market Share (2023)	Remarks
Eli Lilly	Trulicity (dulaglutide)	GLP-1 receptor agonist	35%	Closest direct competitor, slight patent challenges
AstraZeneca	Bydureon (exenatide)	GLP-1 receptor agonist	8%	Older technology, declining market share
Sanofi	Lyxumia (lixisenatide)	GLP-1 receptor agonist	2%	Niche presence
Novo Nordisk (VICTOZA)	VICTOZA (liraglutide)	GLP-1 receptor agonist	30%	Market leader, expanding indications

Key Competitive Advantages for VICTOZA

• Proven efficacy in glycemic control and weight reduction.
• Extensive clinical data supporting cardiovascular benefits [3].
• Subcutaneous weekly dosing for some competitors, but VICTOZA's daily injection remains acceptable.
• Strong brand recognition and established physician base.

Emerging Competition & Innovation

• Oral GLP-1 formulations (e.g., Eli Lilly’s oral semaglutide) pose future threats.
• Combination therapies with SGLT2 inhibitors are gaining momentum.
• Biosimilar entries are limited but could influence future pricing strategies.

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What Is the Revenue and Sales Trajectory?

Historical Revenue Performance

Year	VICTOZA Sales (USD Million)	Year-over-Year Growth	Notes
2017	2,200	10%	Stabilized growth
2018	2,420	10%	Launch in additional markets
2019	2,720	12%	Increased adoption; CV benefits
2020	3,060	12.5%	COVID-19 pandemic resilience
2021	3,530	15%	Peak amid high prescriptions
2022	3,880	10%	Slowed due to market saturation

Note: VICTOZA remains a significant revenue contributor for Novo Nordisk, which posted total revenues of USD 26.6 billion in 2022 [4].

Forecasted Growth (2023–2028)

Year	Projected Revenue (USD Million)	CAGR (2023–2028)	Key Drivers
2023	4,200	8%	Rising global prevalence, expanding indications
2024	4,560	8.5%	Market penetration increases, new markets opening
2025	4,940	8.5%	Competitive advantages sustains market share
2026	5,370	8.5%	Integration into combination therapies, new formulations
2027	5,820	8.5%	Continued global adoption
2028	6,300	8.5%	Broadened indications and clinical evidence

Revenue Drivers

• Expansion in Obesity Market: The FDA approved Saxenda (liraglutide) for obesity in 2014, creating a pipeline for increased VICTOZA utilization.
• Cardiovascular Outcomes: Evidence of CV benefits in LEADER trial (2016) [3] enhances prescribing confidence.
• Emerging Markets: Developing economies contribute 25-30% of sales, with growth expected as access expands.
• Regulatory Approvals: Pending approvals and label expansions (e.g., in pediatric or prediabetes) could further boost sales.

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How Do Regulatory Policies Impact VICTOZA’s Trajectory?

Approval Status & Label Extensions

• FDA (US): Approved for T2DM, with expanded CV indications based on the LEADER trial [3].
• EMA (Europe): Similar approvals; clinical data supports cardiovascular safety.
• Additional Indications: Under evaluation for prediabetes and pediatric use; regulatory decisions will influence market potential.

Reimbursement & Pricing Policies

Region	Reimbursement Status	Impact	Challenges
US	Coverage via Medicare/Commercial	Facilitates patient access	High co-pays for some insurers
Europe	National health systems coverage	Widens access	Pricing negotiations may limit sales
Emerging Markets	Variable; often out-of-pocket	High growth potential	Cost sensitivity

Pricing Trends & Pharmacoeconomic Evaluations

• Tightening of price controls in Europe and Asia may constrain margins.
• Cost-effectiveness analyses favor VICTOZA given CV benefits and weight loss efficacy, supporting reimbursement.

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What Future Opportunities and Risks Lie Ahead?

Opportunities

• Line Extension & Combination Treatments: Fixed-dose combinations (e.g., with basal insulins or SGLT2 inhibitors) enhance adherence.
• New Indications & Off-label Use: Cardiovascular and renal indications present growth avenues.
• Innovations in Drug Delivery: Once-daily or oral formulations can expand access and adherence.
• Emerging Markets: Growing middle class within Asia-Pacific and Africa.

Risks

• Patent Expiry & Biosimilars: Patents for VICTOZA expire in key markets around 2024–2027, risking generic competition.
• Market Saturation: High adoption levels in developed regions limit further growth.
• Competitive Pressure: Oral formulations and novel mechanisms (e.g., dual agonists) threaten market share.
• Regulatory Challenges: Regulatory delays or unfavorable label restrictions could impact sales.

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How Do VICTOZA's Market Metrics Compare to Peers?

Metric	VICTOZA (Liraglutide)	Trulicity (Dulaglutide)	Bydureon (Exenatide)	Lixisenatide (Lyxumia)
Approved Indications	T2DM, obesity, CV	T2DM	T2DM	T2DM
Annual Sales (2023)	USD 4.2B	USD 4.0B	USD 0.4B	USD 0.2B
Dosing Frequency	Daily (SC)	Weekly (SC)	Weekly (SC)	Daily (SC)
Market Share (2023)	~30%	~35%	~8%	~2%
CV Outcome Evidence	Yes (LEADER)	Yes (HARMONY Outcomes)	No	No

Note: VICTOZA's notable CV benefits have positioned it favorably against peers.

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Key Takeaways

• Robust Growth: VICTOZA’s sales are projected to grow at approximately 8–9% annually over the next five years, driven by expanding indications, global access, and clinical evidence of cardiovascular benefits.
• Competitive Edge: Its established efficacy, CV outcomes data, and brand recognition sustain its market leadership against emerging and existing competitors.
• Market Risks: Patent expiries, biosimilar threats, and market saturation in developed regions pose potential headwinds.
• Emerging Opportunities: Combination therapies, new formulations, and expanded indications in obesity and prediabetes are promising growth vectors.
• Regulatory Landscape: Favorable policies and reimbursement strategies underpin revenue stability, but regional differences and regulatory hurdles remain relevant considerations.

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FAQs

1. When will VICTOZA face patent expiry, and how will it affect sales?
Patent protections for VICTOZA are expected to expire between 2024 and 2027 across key markets. Expiry could lead to biosimilar entries, potentially diminishing market share but also driving price competition.

2. How significant is the cardiovascular benefit of VICTOZA in market adoption?
The LEADER trial demonstrated a 13% relative risk reduction in major adverse cardiovascular events (MACE). This evidence has led to label expansions and increased prescriber confidence, emphasizing VICTOZA’s unique position among GLP-1 agonists.

3. What is the outlook for VICTOZA in emerging markets?
Growing diabetes prevalence and increasing healthcare infrastructure suggest substantial upside. Pricing and reimbursement policies will influence penetration, but overall growth prospects remain strong.

4. Are there any ongoing clinical trials that could impact VICTOZA’s indications?
Yes. Trials exploring use in prediabetes, adolescents, and combination therapies could lead to label extensions, further widening its application spectrum.

5. How does VICTOZA compare with oral GLP-1 formulations?
Oral formulations like Eli Lilly’s oral semaglutide offer convenience but currently lack the extensive clinical data and cardiovascular benefits associated with VICTOZA. Competition in efficacy and safety profiles will shape future market share.

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References

1. International Diabetes Federation. (2021). IDF Diabetes Atlas, 9th Edition.
2. World Obesity Federation. (2016). The Global Obesity Observatory.
3. Marso SP, et al. (2016). Liraglutide and Cardiovascular Outcomes in Type 2 Diabetes. N Engl J Med. 375(4): 311-322.
4. Novo Nordisk. (2022). Annual Report 2022.

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In conclusion, VICTOZA remains a pivotal player in the GLP-1 receptor agonist landscape, with a strong trajectory supported by clinical evidence, expanding indications, and market expansion. Strategic positioning, patent management, and innovation will be vital to sustain its growth amidst intensifying competition and regulatory shifts.