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 two branded drugs marketed by Novo and Novo Nordisk Inc, and is included in two NDAs. There are twenty patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Liraglutide has two hundred and three patent family members in twenty-nine countries.

There are seven drug master file entries for liraglutide. Three suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for LIRAGLUTIDE

International Patents:	203
US Patents:	20
Tradenames:	2
Applicants:	2
NDAs:	2
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	3
Clinical Trials:	424
Patent Applications:	7,047
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
University of Chicago	Early Phase 1
Mỹ Đức Hospital	Phase 3
Columbia University	Phase 4

See all LIRAGLUTIDE clinical trials

Generic filers with tentative approvals for LIRAGLUTIDE

Applicant	Application No.	Strength	Dosage Form
		18MG/3ML(6MG/ML)	INJECTABLE;INJECTION

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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		RX	Yes	Yes	8,114,833*PED				Y
Novo	SAXENDA	liraglutide	SOLUTION;SUBCUTANEOUS	206321-001	Dec 23, 2014		RX	Yes	Yes	9,132,239*PED				Y
Novo	SAXENDA	liraglutide	SOLUTION;SUBCUTANEOUS	206321-001	Dec 23, 2014		RX	Yes	Yes	10,376,652		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	RE43834
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	7,235,627

International Patents for LIRAGLUTIDE

Country	Patent Number	Title	Estimated Expiration
Russian Federation	2007114760	УСТРОЙСТВО ДЛЯ ИНЪЕКЦИЙ, СНАБЖЕННОЕ ТОРСИОННОЙ ПРУЖИНОЙ И ПОВОРОТНЫМ ИНДИКАТОРОМ
Russian Federation	2009132183	НАЖИМНАЯ КНОПКА ДЛЯ ИНЪЕКЦИОННОГО УСТРОЙСТВА
European Patent Office	2394656	Formulations de peptide contenant du propylèneglycol qui sont optimales pour la production et l'utilisation dans des dispositifs d'injection (Propylene Glycol-containing peptide formulations which are optimal for production and for use in injection devices)

Supplementary Protection Certificates for LIRAGLUTIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2209800	1490067-4	Sweden		PRODUCT NAME: COMBINATION OF INSULIN DEGLUDEC AND LIRAGLUTIDE; REG. NO/DATE: EU/1/14/974 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

LIRAGLUTIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Liraglutide

Introduction to Liraglutide

Liraglutide, a glucagon-like peptide-1 receptor agonist (GLP-1 RA), is a crucial medication in the management of type 2 diabetes and obesity. Marketed under the brand names Victoza and Saxenda, it has gained significant traction due to its efficacy in regulating blood sugar levels, promoting weight loss, and reducing cardiovascular complications.

Market Size and Forecast

The liraglutide market is poised for substantial growth. As of 2023, the market size was valued at USD 8.24 billion and is projected to reach USD 15.07 billion by 2030, growing at a Compound Annual Growth Rate (CAGR) of 10.58% during the forecast period 2024-2030[1].

Another forecast indicates that the market size is estimated at USD 3.40 billion in 2024 and is expected to reach USD 4 billion by 2029, growing at a CAGR of 3.16% during the same period[3].

Key Drivers of Market Growth

Growing Incidence of Type 2 Diabetes and Obesity

The increasing global prevalence of type 2 diabetes and obesity is a major factor driving the demand for liraglutide. As these conditions become more common, the need for effective treatments like liraglutide rises[1].

Growing Awareness of Diabetes Management

There is a growing emphasis on illness prevention and control, leading to increased awareness of the importance of managing diabetes and obesity. This awareness drives patients to seek out appropriate treatment options, including liraglutide[1].

Positive Regulatory Environment

Regulatory bodies worldwide are increasingly approving liraglutide and similar drugs for the treatment of obesity and diabetes. This positive regulatory environment promotes market expansion and accelerates market access[1].

Technological Developments

Ongoing research and development in the pharmaceutical industry result in improved drug formulations and delivery systems for liraglutide. These advancements enhance the safety and efficacy of the medication, promoting its adoption[1].

Growing Healthcare Spending

Increased healthcare spending globally has made medical services and prescription drugs more accessible. This enhanced affordability is expected to grow the market for liraglutide as more patients can include it in their treatment regimens[1].

Increasing Emphasis on Lifestyle Therapies

Dietary and physical activity interventions are gaining more attention as methods to manage diabetes and obesity. Liraglutide, often used as an adjunct to these therapies, benefits from this trend[1].

Extension of Indications

The expansion of indications for liraglutide, including its use in reducing the risk of heart-related complications in patients with established cardiovascular conditions, further supports market growth[3].

Challenges and Pitfalls

Regulatory Obstacles

The liraglutide market may face significant challenges in obtaining regulatory licenses and complying with other regulatory obligations. Changes in regulations, particularly those related to drugs, can impact the manufacture, sale, and distribution of liraglutide products[1].

Patent Expiration

Patent protection is crucial in the pharmaceutical sector. The expiration of patents for liraglutide formulations can lead to increased competition from generic copies, affecting the market share and profitability of original manufacturers[1].

Pricing Pressures

Pricing pressures from competitors and healthcare payers can hinder market expansion. The availability of generic or cheaper alternatives to liraglutide can impact pricing strategies and limit potential revenue[1].

Side Effects and Safety Concerns

While liraglutide is generally effective, it can have side effects, including gastrointestinal disorders. These safety concerns need to be addressed to maintain patient trust and compliance[5].

Regional Market Dynamics

North America

The North American region holds a significant share of the liraglutide market, driven by the high prevalence of diabetes and obesity, exacerbated by lifestyle changes and dietary habits. Favorable reimbursement policies and robust healthcare infrastructure in this region also contribute to the market's growth[3][4].

Competitive Landscape

The liraglutide market is characterized by a low market concentration, with Novo Nordisk A/S being a major player. Recent partnerships and strategic agreements, such as Biocon's collaboration with Juno Pharmaceuticals for the Canadian market, highlight ongoing efforts to expand the drug's reach[3].

Impact of COVID-19

The COVID-19 pandemic has had a mixed impact on the liraglutide market. On one hand, the pandemic highlighted the importance of managing chronic conditions like diabetes and obesity, which are comorbidities associated with severe COVID-19 outcomes. GLP-1 RAs like liraglutide were found to be beneficial in improving COVID-19 outcomes due to their anti-inflammatory properties[3].

On the other hand, the shift towards telehealth services and remote consultations during the pandemic facilitated easier access to healthcare professionals and medication prescriptions, contributing to sustained demand for liraglutide[4].

Efficacy and Clinical Outcomes

Studies have shown that liraglutide is effective in weight loss and improving glycemic control. For instance, a cohort study found that patients treated with liraglutide experienced a mean percentage body weight change of -2.2% over one year, with factors like persistent medication coverage and higher dosages positively associated with greater weight reduction[2].

Another study highlighted that liraglutide (3.0 mg) resulted in significant weight loss compared to placebo, with 25.2% of patients achieving a weight loss of more than 10% over 56 weeks[5].

Conclusion

The liraglutide market is on a trajectory of steady growth, driven by increasing prevalence of type 2 diabetes and obesity, positive regulatory environments, technological advancements, and growing healthcare spending. While the market faces challenges such as regulatory obstacles, patent expirations, and pricing pressures, its overall outlook remains positive.

Key Takeaways

• Market Growth: The liraglutide market is expected to grow significantly, with a projected value of USD 15.07 billion by 2030.
• Key Drivers: Growing incidence of type 2 diabetes and obesity, increasing awareness of disease management, positive regulatory environment, and technological developments.
• Regional Focus: North America holds a significant share of the market due to high prevalence of diabetes and obesity.
• Challenges: Regulatory obstacles, patent expirations, pricing pressures, and side effects.
• Efficacy: Liraglutide is effective in weight loss and improving glycemic control, with significant clinical outcomes observed in various studies.

FAQs

Q: What is the current market size of liraglutide and its projected growth?

A: The liraglutide market size was valued at USD 8.24 billion in 2023 and is projected to reach USD 15.07 billion by 2030, growing at a CAGR of 10.58% during the forecast period 2024-2030[1].

Q: What are the primary drivers of the liraglutide market growth?

A: The primary drivers include the growing incidence of type 2 diabetes and obesity, increasing awareness of disease management, positive regulatory environment, technological developments, and growing healthcare spending[1].

Q: Which region holds the largest share of the liraglutide market?

A: The North American region holds a significant share of the liraglutide market due to the high prevalence of diabetes and obesity, favorable reimbursement policies, and robust healthcare infrastructure[3][4].

Q: What are the major challenges facing the liraglutide market?

A: The major challenges include regulatory obstacles, patent expirations, pricing pressures, and side effects and safety concerns[1].

Q: How effective is liraglutide in weight loss and glycemic control?

A: Liraglutide has been shown to be effective in weight loss and improving glycemic control, with significant clinical outcomes observed in various studies, including a mean percentage body weight change of -2.2% over one year and weight loss of more than 10% in 25.2% of patients over 56 weeks[2][5].

Sources

1. Verified Market Research: Liraglutide Market Size, Forecast.
2. JAMA Network: One-Year Weight Reduction With Semaglutide or Liraglutide in Patients With Obesity.
3. Mordor Intelligence: Liraglutide Market Size (2024 - 2029).
4. Global Market Insights: Liraglutide and Semaglutide Market Share Report, 2023-2032.
5. JAMA: Efficacy of Liraglutide for Weight Loss Among Patients With Type 2 Diabetes.