LIRAGLUTIDE - Generic Drug Details

What are the generic sources for liraglutide and what is the scope of patent protection?

Liraglutide is the generic ingredient in three branded drugs marketed by Hikma, Lupin Ltd, Nanjing King Friend, Teva Pharms, Novo, and Novo Nordisk Inc, and is included in six NDAs. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

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

There are seven drug master file entries for liraglutide. Eight suppliers are listed for this compound.

Summary for LIRAGLUTIDE

International Patents:	63
US Patents:	2
Tradenames:	3
Applicants:	6
NDAs:	6
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	8
Clinical Trials:	452
Patent Applications:	6,609
Drug Prices:	Drug price trends for LIRAGLUTIDE
What excipients (inactive ingredients) are in LIRAGLUTIDE?	LIRAGLUTIDE excipients list
DailyMed Link:	LIRAGLUTIDE at DailyMed

See drug prices for LIRAGLUTIDE

Recent Clinical Trials for LIRAGLUTIDE

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

Sponsor	Phase
Karolinska Institutet	NA
Evira AB	NA
Insel Gruppe AG, University Hospital Bern	NA

See all LIRAGLUTIDE clinical trials

Pharmacology for LIRAGLUTIDE

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

Anatomical Therapeutic Chemical (ATC) Classes for LIRAGLUTIDE

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 LIRAGLUTIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
SAXENDA	Injection	liraglutide	18 mg/3 mL prefilled syringe	206321	1	2021-08-16
VICTOZA	Injection	liraglutide	18 mg/3 mL prefilled syringe	022341	1	2016-12-12

US Patents and Regulatory Information for LIRAGLUTIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novo	SAXENDA	liraglutide	SOLUTION;SUBCUTANEOUS	206321-001	Dec 23, 2014	AP2	RX	Yes	Yes	9,968,659*PED				Y
Lupin Ltd	LIRAGLUTIDE	liraglutide	SOLUTION;SUBCUTANEOUS	215421-001	Jul 22, 2025	AP1	RX	No	No
Nanjing King Friend	LIRAGLUTIDE	liraglutide	SOLUTION;SUBCUTANEOUS	218115-001	Apr 2, 2025	AP1	RX	No	No
Hikma	LIRAGLUTIDE	liraglutide	SOLUTION;SUBCUTANEOUS	215503-001	Dec 23, 2024	AP1	RX	No	No
Teva Pharms	LIRAGLUTIDE	liraglutide	SOLUTION;SUBCUTANEOUS	214568-001	Aug 27, 2025	AP2	RX	No	No
Novo Nordisk Inc	VICTOZA	liraglutide	SOLUTION;SUBCUTANEOUS	022341-001	Jan 25, 2010	AP1	RX	Yes	Yes	9,968,659*PED				Y
Novo Nordisk Inc	VICTOZA	liraglutide	SOLUTION;SUBCUTANEOUS	022341-001	Jan 25, 2010	AP1	RX	Yes	Yes	8,114,833*PED				Y

Expired US Patents for LIRAGLUTIDE

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	SAXENDA	liraglutide	SOLUTION;SUBCUTANEOUS	206321-001	Dec 23, 2014	11,446,443
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
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	RE41956*PED

International Patents for LIRAGLUTIDE

Country	Patent Number	Title	Estimated Expiration
Denmark	3423082
China	102784386	Propylene glycol-containing peptide formulations which are optimal for production and for use in injection devices
Hungary	E038395
Canada	3013532	LIRAGLUTIDE UTILISE DANS LE TRAITEMENT DE MALADIES CARDIOVASCULAIRES (LIRAGLUTIDE IN CARDIOVASCULAR CONDITIONS)
Spain	2893755
Portugal	1687019
Australia	2017225841	Liraglutide in cardiovascular conditions

Supplementary Protection Certificates for LIRAGLUTIDE

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
0944648	09C0054	France		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
2209800	132014902311502	Italy		PRODUCT NAME: INSULINA DEGLUDEC/LIRAGLUTIDE(XULTOPHY); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/947, 20140918
2209800	C300698	Netherlands		PRODUCT NAME: INSULINE DEGLUDEC EN LIRAGLUTIDE; REGISTRATION NO/DATE: EU/1/14/94765041 2014120918
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
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

Market Dynamics and Financial Trajectory for Liraglutide

Last updated: November 17, 2025

---

Introduction

Liraglutide, marketed under brand names such as Victoza and Saxenda, is a once-daily injectable glucagon-like peptide-1 (GLP-1) receptor agonist developed by Novo Nordisk. It is approved for managing type 2 diabetes mellitus (T2DM) and obesity. With its expanding therapeutic indications, evolving regulatory landscape, and a competitive pharmaceutical environment, understanding the market dynamics and financial trajectory of liraglutide offers insights into its commercial potential and strategic positioning.

---

Market Overview

Therapeutic Indications and Growing Demand

Liraglutide primarily targets two indications:

• Type 2 Diabetes Mellitus: Approved globally for glycemic control, liraglutide has become an integral component of T2DM management. Its efficacy in reducing HbA1c levels and weight loss benefits have differentiated it in a crowded market dominated by other GLP-1 receptor agonists.

• Obesity Management: Marketed as Saxenda, liraglutide gained FDA approval for chronic weight management in obese or overweight adults with comorbidities in 2014. The global obesity epidemic has fueled demand, positioning liraglutide as a key pharmacological tool for weight control.

Market Penetration and Competition

The global diabetes therapeutics market is projected to reach $118 billion by 2027 (Grand View Research, 2022). While insulin maintains a significant market share, GLP-1 receptor agonists like liraglutide are experiencing accelerated growth due to their cardiovascular benefits and favorable side effect profiles.

Competitive landscape includes:

• Other GLP-1 receptor agonists: Semaglutide (Ozempic, Wegovy), dulaglutide, exenatide.
• DPP-4 inhibitors: Sitagliptin, linagliptin.
• SGLT2 inhibitors: Empagliflozin, canagliflozin.

Among these, semaglutide, with once-weekly dosing and superior weight loss efficacy, poses the most significant competitive threat, potentially impacting liraglutide’s market share.

---

Market Dynamics

Regulatory Environment and Label Expansions

Regulatory agencies such as the FDA and EMA have progressively expanded liraglutide's approved indications, broadening its market potential. Notably:

• Approval for obesity management has unlocked a sizable market segment.
• Recent cardiovascular outcome trials (CVOTs) demonstrate liraglutide's benefits in reducing major adverse cardiovascular events (MACE) in T2DM patients, further validating its positioning.

Pricing Strategies and Reimbursement

Liraglutide commands premium pricing due to its documented efficacy and safety profile. Reimbursement decisions from payers significantly influence uptake, especially in mass-market obesity applications. Cost-effectiveness analyses demonstrate positive valuations, supporting formulary inclusion.

Clinical Research and Pipeline Developments

Ongoing research aims to optimize dosing, improve patient adherence, and expand indications. Novo Nordisk’s exploration of fixed-dose combinations with other agents indicates a commitment to enhancing therapeutic profiles and competitive differentiation.

---

Financial Trajectory

Revenue Generation and Growth

• In 2022, Novo Nordisk reported that Victoza revenue from liraglutide was approximately $2 billion, dominated by T2DM sales, with increased contributions from Saxenda for obesity (Novonordisk Annual Report, 2022).
• The obesity segment has shown significant growth, driven by increased prevalence and expanding approval of higher doses.

Market Share and Forecast

Projection models estimate:

• CAGR for liraglutide to hover around 8-10% over the next five years, reflecting steady demand growth.
• Obesity market segment expected to expand at a higher CAGR (~12%) due to rising obesity rates and increased awareness.

However, the imminent entry of once-weekly semaglutide formulations, which have demonstrated superior weight loss, could temper liraglutide’s growth trajectory.

Pricing and Revenue Impact from Competition

Competitive pressures from new formulations threaten premium pricing strategies. However, liraglutide's established safety and efficacy record, combined with long-term CVOT data, support sustained revenue streams, especially in cardiovascular risk mitigation.

---

Emerging Trends and Opportunities

• Digital health integration: Telemedicine and digital adherence tools present avenues for improved patient engagement.
• Combination therapies: Development of fixed-dose combinations (e.g., with insulin) could broaden usage.
• Expanding indications: Potential approval for non-alcoholic steatohepatitis (NASH) and other metabolic disorders.

---

Risks and Challenges

• Market saturation: Growing competition, especially from weekly formulations like semaglutide, may cap growth.
• Pricing pressures: Payer strategies may limit premium pricing.
• Regulatory hurdles: Extended approval processes or label restrictions could impede market expansion.
• Patent expirations: Although patents provide exclusivity, generic or biosimilar entrants may erode revenue.

---

Key Takeaways

• Liraglutide remains a cornerstone in T2DM and obesity management, with a robust and expanding market.
• Competitive landscape shifts, notably the emergence of semaglutide, will influence liraglutide’s market share.
• Regulatory approvals for broader indications and positive CVOT outcomes support sustained demand.
• Strategic positioning, including pricing, pipeline innovation, and digital integration, will determine long-term financial success.
• Healthcare providers and payers will continue to favor therapies with proven efficacy, safety, and cardiovascular benefits, bolstering liraglutide’s market trajectory.

---

FAQs

1. How does liraglutide compare to other GLP-1 receptor agonists?
Liraglutide offers proven efficacy in glycemic control and weight loss, backed by extensive CVOT data. However, newer agents like semaglutide provide once-weekly dosing and may offer superior weight reduction, influencing market preferences.

2. What factors could limit the future growth of liraglutide?
Increased adoption of competing agents, pricing pressures, patent expirations, and regulatory constraints can constrain growth. Additionally, market saturation and changing treatment guidelines may impact demand.

3. What is the outlook for liraglutide’s revenue in the coming years?
While projected to grow at a healthy CAGR of around 8-10%, revenue gains may decelerate due to competition. Continued expansion in obesity and cardiovascular indications will be pivotal.

4. Are there upcoming developments or pipeline drugs related to liraglutide?
Yes, research into combination therapies, new formulations (e.g., once-weekly), and exploring other metabolic indications are underway, which could extend liraglutide’s market relevance.

5. How significant is the FDA’s approval of Saxenda for obesity?
It marked a substantial expansion of liraglutide’s market, addressing a massive global health challenge. The recognition of obesity as a chronic disease has elevated pharmacological interventions like Saxenda, promising sustained revenue growth.

---

Sources

[1] Grand View Research. (2022). Global Diabetes Therapeutics Market Report.
[2] Novo Nordisk Annual Report. (2022).
[3] U.S. Food and Drug Administration. (2014). Approval of Saxenda for Weight Management.
[4] Clinical trials registry. (2022). CVOTs and other ongoing studies on liraglutide.