Insulin glargine - Biologic Drug Details

Summary for insulin glargine

Tradenames:	4
High Confidence Patents:	3
Applicants:	4
BLAs:	7
Suppliers: see list	6
Recent Clinical Trials:	See clinical trials for insulin glargine
Drug Prices:	Drug price information for insulin glargine
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for insulin glargine

Recent Clinical Trials for insulin glargine

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Diabetes & Endocrinology Foundation	N/A
King Faisal Specialist Hospital & Research Center	N/A
Aarhus University Hospital, Department of Nephrology	Phase 4

See all insulin glargine clinical trials

Recent Litigation for insulin glargine

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
Geoscope Technologies Pte. Ltd. v. Google LLC	2023-10-02
Astellas Pharma Inc. v. Lupin Ltd.	2023-07-28
ACQIS LLC v. Hon Hai Precision Industry Co., Ltd.	2023-04-10

See all insulin glargine litigation

Pharmacology for insulin glargine

Established Pharmacologic Class	Insulin Analog
Chemical Structure	Insulin

Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

1. Brand-side disclosures in response to biosimilar applications

These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

2. General brand-side disclosures

These patents were identified from searching drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

3. Patents from broad patent text search

For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for insulin glargine Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for insulin glargine Derived from Company Disclosures

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Sanofi-aventis U.s. Llc	LANTUS	insulin glargine	Injection	021081	5,370,629	2012-02-21	Company disclosures
Sanofi-aventis U.s. Llc	LANTUS	insulin glargine	Injection	021081	5,509,905	2013-04-23	Company disclosures
Sanofi-aventis U.s. Llc	LANTUS	insulin glargine	Injection	021081	5,656,722	2014-08-12	Company disclosures

3) Low Certainty: US Patents for insulin glargine Derived from Patent Text Search

These patents were obtained by searching patent claims

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Sanofi-aventis U.s. Llc	LANTUS	insulin glargine	Injection	021081	10,004,686	2025-05-23	Patent claims search
Sanofi-aventis U.s. Llc	LANTUS	insulin glargine	Injection	021081	10,016,338	2033-03-11	Patent claims search
Sanofi-aventis U.s. Llc	LANTUS	insulin glargine	Injection	021081	10,029,011	2029-11-13	Patent claims search
Sanofi-aventis U.s. Llc	LANTUS	insulin glargine	Injection	021081	10,092,513	2033-04-03	Patent claims search

International Patents for insulin glargine

Country	Patent Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	9316740
Austria	E93868
Canada	2108692
Norway	2001023

Supplementary Protection Certificates for insulin glargine

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
00C0023	France		PRODUCT NAME: INSULIN GLARGINE; NAT. REGISTRATION NO/DATE: EU/0/00/134/001 20000609; FIRST REGISTRATION: EU/1/00/134/001 20000609
C300019	Netherlands		PRODUCT NAME: INSULINE GLARGINE,DESGEWENST IN DE VORM VAN EEN FYSIOLOGISCH GESCHIKT ZOUT; REGISTRATION NO/DATE: EU/1/00/134/001 - 007 20000609
2017/022	Ireland		PRODUCT NAME: A COMPOSITION COMPRISING INSULIN GLARGINE, OR A PHARMACOLOGICALLY TOLERABLE SAFT THEREOF, AND LIXISENATIDE, OR A PHARMACOLOGICALLY TOLERABLE SALT THEREOF.; REGISTRATION NO/DATE: EU/1/16/1157 20170111
34/2000	Austria		PRODUCT NAME: LANTUS - INSULIN GLARGIN; REGISTRATION NO/DATE: EU/1/00/134/001 - EU/1/00/134/007 20000609

Insulin Glargine Market Dynamics and Financial Trajectory

Market Size and Growth Projections

The insulin glargine market is poised for significant growth over the coming years. As of 2024, the market size is estimated to be around USD 1.54 billion and is expected to grow at a Compound Annual Growth Rate (CAGR) of 6.28% to reach USD 2.09 billion by 2029[1].

On a broader scale, the global insulin glargine market is valued at USD 5.45 billion in 2024 and is projected to reach USD 8.43 billion by 2031, with a CAGR of 6.4% during this period[3].

Drivers of Market Growth

Several factors are driving the growth of the insulin glargine market:

Rising Prevalence of Diabetes

The increasing prevalence of diabetes, particularly Type 1 and Type 2, is a major driver. People with diabetes require continuous management, often involving multiple daily injections of insulin or insulin pump therapy, which fuels the demand for insulin glargine[1].

Technological Advancements

Advancements in drug delivery devices such as wearable and smart insulin pens and pumps are enhancing the usability and efficacy of insulin glargine, contributing to market growth[3].

Introduction of Biosimilars

The entry of biosimilar insulin glargine products, such as Basaglar and Semglee, has increased competition and reduced prices, making insulin glargine more accessible to a wider population[2][5].

Key Players and Market Share

The insulin glargine market is dominated by several key players:

• Sanofi Aventis: Known for its product Lantus, which has maintained a significant market share despite competition from biosimilars[2][5].
• Novo Nordisk AS: A major player with a strong presence in the global insulin market.
• Eli Lilly and Company: Manufacturer of Basaglar, a biosimilar insulin glargine that has gained substantial market share[1][4].
• Biocon: Another significant player in the biosimilar insulin glargine market[1][4].

Regional Market Dynamics

North America

North America holds the largest market share in the insulin glargine market, driven by a large diabetic population in the U.S. and the presence of major insulin manufacturers like Sanofi, Eli Lilly, and Novo Nordisk[1][3].

Asia Pacific

The Asia Pacific region, particularly countries like China and India, is expected to be the fastest-growing market. Factors such as rapid urbanization, rising income levels, and improving healthcare access are contributing to this growth[3].

Price Dynamics

The pricing of insulin glargine has seen significant changes in recent years:

Price Increases and Decreases

Prior to 2015, the list price of Lantus, the only insulin glargine product on the market, increased steadily. However, following the FDA approval of Basaglar, the average net price of all insulin glargine products declined from 2015 to 2020[2].

Impact of Biosimilars

The introduction of biosimilars like Basaglar and Semglee has led to a decline in net prices. For instance, the net price of Lantus declined by 5.2% per 100 IU per quarter after the approval of Basaglar[2].

Recent Price Adjustments

In 2023, Sanofi announced a 78% price reduction for Lantus and a $35 cap on out-of-pocket costs for patients with commercial insurance, further impacting market dynamics[5].

Challenges and Limitations

Despite the growth, the market faces several challenges:

High Cost of Insulin

The high cost of insulin glargine, particularly branded products like Lantus, remains a significant barrier. For example, Lantus can cost around $274 per month, making it inaccessible to many patients[3].

Payer Controls

Payer controls, such as prior authorization and step therapy, are limiting the uptake of biosimilar insulin glargine products like Semglee, despite patient demand[5].

Stringent Regulations

Stringent regulations for the approval of insulin products can slightly hamper market growth during the forecast years[3].

Market Opportunities

Increasing Awareness

There is an increasing awareness among people about diabetes management, which is driving the demand for effective treatments like insulin glargine[3].

Expanding Access

Expanding access to insulin therapies in emerging markets is another significant opportunity. Regional trade agreements and improving healthcare access are facilitating greater market penetration in Asia Pacific nations[3].

Technological Innovations

Technological advancements in drug delivery devices are a key driver of the market:

Wearable and Smart Insulin Devices

Innovations in wearable and smart insulin pens and pumps are enhancing patient compliance and the overall efficacy of insulin glargine therapy[3].

Illustrative Statistics

• Market Size: Expected to reach USD 2.09 billion by 2029 from USD 1.54 billion in 2024[1].
• CAGR: 6.28% from 2024 to 2029[1].
• Biosimilar Impact: Basaglar accounted for up to 42.2% of sales by Q2 of 2020, while Lantus maintained 46.2%[2].
• Price Reduction: Sanofi's 78% price reduction for Lantus and the introduction of a $35 cap on out-of-pocket costs[5].

Quotes from Industry Experts

"The approval of Basaglar was followed by a substantial change in the trajectory of net prices for insulin glargine products." - Researchers in JAMA Internal Medicine[2].

Highlight and Citation

"The introduction of biosimilar insulin glargine products has led to a decline in net prices. For instance, the net price of Lantus declined by 5.2% per 100 IU per quarter after the approval of Basaglar." - JAMA Internal Medicine[2].

Key Takeaways

• The insulin glargine market is expected to grow significantly, driven by the rising prevalence of diabetes and technological advancements.
• The introduction of biosimilar products has reduced prices and increased accessibility.
• North America dominates the market, but the Asia Pacific region is expected to be the fastest-growing.
• High costs and payer controls remain significant challenges.
• Technological innovations in drug delivery devices are enhancing market growth.

FAQs

Q: What is the current size of the insulin glargine market? A: The insulin glargine market size is estimated to be USD 1.54 billion in 2024[1].

Q: Who are the key players in the insulin glargine market? A: Key players include Sanofi Aventis, Novo Nordisk AS, Biocon, Eli Lilly and Company, and Julphar[1].

Q: How has the introduction of biosimilars affected the market? A: The introduction of biosimilars like Basaglar and Semglee has led to a decline in net prices and increased competition in the market[2][5].

Q: What are the major challenges facing the insulin glargine market? A: High costs, payer controls, and stringent regulations are significant challenges[3][5].

Q: Which region is expected to be the fastest-growing market for insulin glargine? A: The Asia Pacific region, particularly countries like China and India, is expected to be the fastest-growing market[3].

Cited Sources

1. Mordor Intelligence: Insulin Glargine Market - Size & Share - Mordor Intelligence.
2. Center for Biosimilars: Average Net Price for Insulin Glargine Declined After Basaglar Won FDA Approval.
3. Coherent Market Insights: Insulin Glargine Market Size & Share Analysis - Growth Trends.
4. Kings Research: Insulin Glargine Market Size & Share, Global Report [2031].
5. AJMC: Payer Controls Limiting Semglee Uptake Despite Patient Demand.