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

Recent Clinical Trials for insulin glargine

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Changzhou No.2 People's Hospital	PHASE4
Xiangya Hospital of Central South University	PHASE4
Jiangsu Province Hospital of Traditional Chinese Medicine	PHASE4

See all insulin glargine clinical trials

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. DrugPatentWatch analysis and 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 DrugPatentWatch Analysis and 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	2013-10-13	DrugPatentWatch analysis and company disclosures
Sanofi-aventis U.s. Llc	LANTUS	insulin glargine	Injection	021081	5,509,905	2013-10-13	DrugPatentWatch analysis and company disclosures
Sanofi-aventis U.s. Llc	LANTUS	insulin glargine	Injection	021081	5,656,722	2014-09-12	DrugPatentWatch analysis and company disclosures
Eli Lilly And Company	BASAGLAR	insulin glargine	Injection	205692	5,656,722	2014-09-12	DrugPatentWatch analysis and company disclosures
Eli Lilly And Company	BASAGLAR	insulin glargine	Injection	205692	7,476,652	2025-03-25	DrugPatentWatch analysis and company disclosures
Eli Lilly And Company	BASAGLAR	insulin glargine	Injection	205692	7,713,930	2028-12-04	DrugPatentWatch analysis and 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	2033-06-12	Patent claims search
Sanofi-aventis U.s. Llc	LANTUS	insulin glargine	Injection	021081	10,016,338	2036-12-20	Patent claims search
Sanofi-aventis U.s. Llc	LANTUS	insulin glargine	Injection	021081	10,029,011	2030-11-11	Patent claims search
Sanofi-aventis U.s. Llc	LANTUS	insulin glargine	Injection	021081	10,092,513	2034-04-01	Patent claims search
Sanofi-aventis U.s. Llc	LANTUS	insulin glargine	Injection	021081	10,117,909	2036-11-01	Patent claims search
Sanofi-aventis U.s. Llc	LANTUS	insulin glargine	Injection	021081	10,118,956	2035-11-30	Patent claims search

International Patents for insulin glargine

Country	Patent Number	Estimated Expiration
Japan	6038976
Estonia	9900313
South Korea	101419160
South Korea	20060010721
Portugal	1603610
Australia	2004216830

Supplementary Protection Certificates for insulin glargine

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0091020-8 0090020-9	Sweden		PRODUCT NAME: LANTUS - INSULIN GLARGIN; REGISTRATION NO/DATE: 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
00C0023	France		PRODUCT NAME: INSULIN GLARGINE; NAT. REGISTRATION NO/DATE: EU/0/00/134/001 20000609; FIRST REGISTRATION: EU/1/00/134/001 20000609
SPC/GB00/022	United Kingdom		PRODUCT NAME: INSULIN GLARGINE (LANTUS) OPTIONALLY IN THE FORM OF ESTERS THEREOF OR PHYSIOLOGICALLY TOLERATED SALTS THEREOF.; REGISTERED: UK EU/1/00/134/001 20000609; UK EU/1/00/134/002 20000609; UK EU/1/00/134/003 20000609; UK EU/1/00/134/004 20000609; UK EU/1/00/134/005 20000609; UK EU/1/00/134/006 20000609; UK EU/1/00/134/007 20000609
10075022	Germany		PRODUCT NAME: INSULIN GLARGIN (LANTUS ); REGISTRATION NO/DATE: EU/1/00/134/001-007 20000609
SZ 34/2000	Austria		PRODUCT NAME: LANTUS - INSULIN GLARGIN

Market Dynamics and Financial Trajectory for the Biologic Drug: Insulin Glargine

Last updated: November 20, 2025

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Introduction

Insulin glargine, a long-acting recombinant human insulin analog, represents a cornerstone in the management of diabetes mellitus, particularly type 1 and type 2 diabetes. Its pharmacokinetic profile ensures a consistent basal insulin level, reducing glycemic variability. As a biologic therapeutic, insulin glargine's market performance is driven by evolving clinical needs, regulatory landscapes, and competitive pressures. Analyzing its market dynamics and financial trajectory provides crucial insights for stakeholders across pharmaceutical and healthcare sectors.

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Global Market Overview

The insulin market is a multi-billion-dollar sector, with projections reaching over USD 50 billion by 2025 (GlobalData, 2021). Insulin glargine, marketed under品牌 names such as Lantus (Sanofi) and Toujeo (Sanofi), accounts for a substantial share, estimated at around 25-30% of the long-acting insulin segment. Growth is propelled by increasing diabetes prevalence globally, especially in emerging markets, coupled with technological advancements and shifting prescriptions toward long-acting formulations.

The International Diabetes Federation (IDF) estimates approximately 537 million adults worldwide were living with diabetes in 2021, a number projected to reach 643 million by 2030. Rising diabetes burden underscores the expanding demand for insulin therapies, including glargine, underpinning its market resilience.

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Market Drivers

1. Increasing Diabetes Prevalence: The global rise in diabetes catalyzes demand. Urbanization, sedentary lifestyles, and obesity contribute to the growing need for effective, long-acting insulins like insulin glargine.

2. Advancements in Insulin Formulations: The development of biosimilars and next-generation long-acting insulins offers competitive options, but insulin glargine remains preferred due to its established safety profile and extensive clinical data.

3. Favorable Regulatory Environment: Regulatory approvals in multiple jurisdictions, including the US FDA and EMA, facilitate broad market access. Additionally, patent expirations have spurred biosimilar development, intensifying competition but also expanding options for payers and patients.

4. Expanding Access in Emerging Markets: Countries like India, China, and Brazil are witnessing rapid adoption of insulin therapies. Local manufacturing and price negotiations are influencing market dynamics, increasing insulin glargine’s reach.

5. Shift Toward Value-Based Care: Increased emphasis on glycemic control reduces complications, favoring long-acting insulins that improve adherence and clinical outcomes.

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Competitive Landscape

The insulin glargine market is marked by intense competition, primarily between innovator products and biosimilars. Sanofi's Lantus (insulin glargine U100) has historically dominated, but patent cliffs have allowed biosimilar entrants, notably:

• Basaglar (Eli Lilly/Amgen): Approved as a biosimilar to Lantus in several markets, capturing significant share.
• Semglee (Mylan/Biocon): Approved as an interchangeable biosimilar in the US.
• Toujeo (Sanofi): A more concentrated U300 formulation offering improved pharmacokinetics and patient convenience.

The emergence of biosimilars has led to increased price competition, pressuring margins for innovator companies. Nonetheless, brand recognition, clinical experience, and formulations (U300, Hilucagon, or other modified versions) sustain premium pricing for some products.

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Regulatory and Patent Trajectory

Patent expirations of Lantus in key markets have catalyzed biosimilar proliferation. The Orphan Drug Act and patent litigations affect market timing and entry strategies. Regulatory pathways for biosimilars, including the FDA's biosimilar guidelines and EMA's biosimilar regulations, lower barriers for generic-like competitors, impacting pricing and access.

Sanofi's subsequent formulations, such as Toujeo and the newer Toujeo Max SoloStar, offer differentiation but face pricing pressures from biosimilar products. The ongoing patent litigation and approval delays influence the innovation pipeline and market stability.

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Market Challenges and Opportunities

Challenges:

• Pricing Pressures: Biosimilar competition has led to significant price reductions, affecting revenue streams.
• Reimbursement and Access: Payer negotiations and formulary restrictions can limit market penetration.
• Patient Preferences: Injectable insulin adherence depends on device ease-of-use and dosing flexibility; innovations are necessary to sustain growth.

Opportunities:

• Innovative Delivery Devices: Prefilled pens and smart technology enhance adherence.
• Personalized Medicine: Pharmacogenomics tailoring can elevate insulin efficacy.
• Emerging Market Expansion: Strategic pricing and localized manufacturing enhance market share.

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Financial Outlook and Revenue Projections

Sanofi, the primary marketer of insulin glargine, reported revenues exceeding EUR 8 billion from basal insulins in 2021, with insulin glargine constituting a major share. Biosimilar entrants have eroded margins, prompting Sanofi to innovate with formulations like Toujeo and advent of digital health integrations.

Analysts project a compound annual growth rate (CAGR) of approximately 4-7% for the long-acting insulin segment over the next five years, driven chiefly by:

• Incremental volume increases in emerging markets.
• Uptake of biosimilar alternatives, which may reduce list prices but expand overall volume.
• Market penetration of innovative formulations providing differentiation and premium pricing.

Financial Trajectory Factors

• Patents and Biosimilar Entry: The expiration of primary patents on Lantus in major markets from 2015-2017 led to biosimilar launches that initially pressured prices, but volume growth offset some revenue declines.
• Regulatory Approvals: New formulations and biosimilars being approved bolster market diversity.
• Manufacturing Costs and Pricing Strategies: Cost efficiencies in biosimilar manufacturing and tiered pricing models are shaping profitability.

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Conclusion and Strategic Considerations

Insulin glargine remains integral to diabetes treatment, with a resilient market despite mounting biosimilar competition. Its future financial trajectory hinges on innovation, market expansion, and pricing strategies. Companies must balance patent management with the need for product differentiation and access expansion, especially in underserved regions.

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Key Takeaways

• The rising global diabetes burden sustains demand for insulin glargine, fostering long-term market growth.
• Biosimilar competition has induced pricing pressures, necessitating strategic innovation and differentiation.
• Emerging markets present significant growth opportunities, driven by urbanization and increasing healthcare access.
• Regulatory pathways and patent protections influence market entry and pricing strategies.
• Continuous product innovation, including formulation improvements and digital health integration, is vital for maintaining market relevance and financial stability.

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FAQs

1. How have biosimilars affected the insulin glargine market?
Biosimilar entrants like Basaglar and Semglee have increased price competition, reducing revenue margins for originator brands but expanding overall market volume and access, especially in cost-sensitive regions.

2. What are the main factors influencing the future growth of insulin glargine?
Market growth is driven by rising diabetes prevalence, expanding access in emerging markets, innovations in product formulations, and strategic biosimilar adoption.

3. How do patent expirations impact the insulin glargine market?
Patent expirations open pathways for biosimilar competition, lowering prices and increasing market penetration, but also prompt originator companies to innovate or defend market share via regulatory and legal strategies.

4. What technological innovations are shaping insulin glargine's market trajectory?
Advancements include high-concentration formulations (U300), pen device technology, digital health integration, and personalized dosing solutions.

5. What are the primary challenges for insulin glargine's market sustainability?
Pricing pressures from biosimilars, reimbursement restrictions, patient preferences, and regulatory hurdles pose ongoing challenges; however, market expansion and product innovation offer pathways for sustained growth.

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References

1. GlobalData. (2021). Diabetes Care Market Report.
2. International Diabetes Federation. (2021). IDF Diabetes Atlas 2021.
3. U.S. FDA. (2019). Guidance for Industry: Biosimilar Product Development.
4. Sanofi. (2022). Annual Report and Market Strategy Overview.