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Last Updated: April 2, 2025

Liraglutide - Generic Drug Details


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

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

Liraglutide has one hundred and eighty-one patent family members in twenty-nine countries.

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

Summary for liraglutide
International Patents:181
US Patents:19
Tradenames:3
Applicants:3
NDAs:3
Drug Master File Entries: 7
Finished Product Suppliers / Packagers: 5
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
Drug Prices for liraglutide

See drug prices for liraglutide

Recent Clinical Trials for liraglutide

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

SponsorPhase
University of ChicagoEarly Phase 1
Mỹ Đức HospitalPhase 3
Columbia UniversityPhase 4

See all liraglutide clinical trials

Pharmacology for liraglutide
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

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Novo Nordisk Inc VICTOZA liraglutide SOLUTION;SUBCUTANEOUS 022341-001 Jan 25, 2010 AP RX Yes Yes ⤷  Try for Free ⤷  Try for Free Y ⤷  Try for Free
Novo Nordisk Inc VICTOZA liraglutide SOLUTION;SUBCUTANEOUS 022341-001 Jan 25, 2010 AP RX Yes Yes ⤷  Try for Free ⤷  Try for Free Y ⤷  Try for Free
Novo SAXENDA liraglutide SOLUTION;SUBCUTANEOUS 206321-001 Dec 23, 2014 RX Yes Yes ⤷  Try for Free ⤷  Try for Free Y ⤷  Try for Free
Novo SAXENDA liraglutide SOLUTION;SUBCUTANEOUS 206321-001 Dec 23, 2014 RX Yes Yes ⤷  Try for Free ⤷  Try for Free Y ⤷  Try for Free
Novo SAXENDA liraglutide SOLUTION;SUBCUTANEOUS 206321-001 Dec 23, 2014 RX Yes Yes ⤷  Try for Free ⤷  Try for Free Y ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 5 of 5 entries

Expired US Patents for liraglutide

ApplicantTradenameGeneric NameDosageNDAApproval DatePatent No.Patent Expiration
Novo SAXENDA liraglutide SOLUTION;SUBCUTANEOUS 206321-001 Dec 23, 2014 ⤷  Try for Free ⤷  Try for Free
Novo SAXENDA liraglutide SOLUTION;SUBCUTANEOUS 206321-001 Dec 23, 2014 ⤷  Try for Free ⤷  Try for Free
Novo Nordisk Inc VICTOZA liraglutide SOLUTION;SUBCUTANEOUS 022341-001 Jan 25, 2010 ⤷  Try for Free ⤷  Try for Free
Novo Nordisk Inc VICTOZA liraglutide SOLUTION;SUBCUTANEOUS 022341-001 Jan 25, 2010 ⤷  Try for Free ⤷  Try for Free
Novo Nordisk Inc VICTOZA liraglutide SOLUTION;SUBCUTANEOUS 022341-001 Jan 25, 2010 ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>Patent No.>Patent Expiration
Showing 1 to 5 of 5 entries

International Patents for liraglutide

CountryPatent NumberTitleEstimated Expiration
Poland 1909870 ⤷  Try for Free
Russian Federation 2008101973 ⤷  Try for Free
Russian Federation 2389514 МЕХАНИЗМ УСТАНОВКИ ДОЗЫ ДЛЯ ШПРИЦА-РУЧКИ (DOSE SETTING MECHANISM FOR HANDLE SYRINGE) ⤷  Try for Free
South Korea 101243648 ⤷  Try for Free
Spain 2893755 ⤷  Try for Free
>Country>Patent Number>Title>Estimated Expiration
Showing 1 to 5 of 5 entries

Supplementary Protection Certificates for liraglutide

Patent NumberSupplementary Protection CertificateSPC CountrySPC ExpirationSPC Description
0944648 09C0054 France ⤷  Try for Free 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 122014000114 Germany ⤷  Try for Free PRODUCT NAME: KOMBINATION VON INSULIN DEGLUDEC UND LIRAGLUTIDE; REGISTRATION NO/DATE: EU/1/14/947 20140918
2209800 132014902311502 Italy ⤷  Try for Free PRODUCT NAME: INSULINA DEGLUDEC/LIRAGLUTIDE(XULTOPHY); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/947, 20140918
2209800 14C0085 France ⤷  Try for Free PRODUCT NAME: LIRAGLUTIDE ET INSULINE DEGLUDEC; REGISTRATION NO/DATE: EU/1/14/947 20140918
2209800 C300698 Netherlands ⤷  Try for Free PRODUCT NAME: INSULINE DEGLUDEC EN LIRAGLUTIDE; REGISTRATION NO/DATE: EU/1/14/94765041 2014120918
>Patent Number>Supplementary Protection Certificate>SPC Country>SPC Expiration>SPC Description
Showing 1 to 5 of 5 entries

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.

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