TOUJEO Drug Profile

Summary for Tradename: TOUJEO

High Confidence Patents:	6
Applicants:	1
BLAs:	1
Drug Prices:	Drug price information for TOUJEO

See drug prices for TOUJEO

Pharmacology for TOUJEO

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 company disclosures

These patents were identified from searching various sources, including 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 TOUJEO Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for TOUJEO 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	TOUJEO	insulin glargine	Injection	206538	7,713,930	2028-12-04	DrugPatentWatch analysis and company disclosures
Sanofi-aventis U.s. Llc	TOUJEO	insulin glargine	Injection	206538	8,637,473	2031-05-03	DrugPatentWatch analysis and company disclosures
Sanofi-aventis U.s. Llc	TOUJEO	insulin glargine	Injection	206538	8,992,492	2031-09-27	DrugPatentWatch analysis and company disclosures
Sanofi-aventis U.s. Llc	TOUJEO	insulin glargine	Injection	206538	9,254,342	2035-03-10	DrugPatentWatch analysis and company disclosures
Sanofi-aventis U.s. Llc	TOUJEO	insulin glargine	Injection	206538	9,522,174	2034-12-09	DrugPatentWatch analysis and company disclosures
Sanofi-aventis U.s. Llc	TOUJEO	insulin glargine	Injection	206538	9,522,175	2034-04-02	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for TOUJEO 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	TOUJEO	insulin glargine	Injection	206538	10,004,686	2033-06-12	Patent claims search
Sanofi-aventis U.s. Llc	TOUJEO	insulin glargine	Injection	206538	10,016,338	2036-12-20	Patent claims search
Sanofi-aventis U.s. Llc	TOUJEO	insulin glargine	Injection	206538	10,092,513	2034-04-01	Patent claims search
Sanofi-aventis U.s. Llc	TOUJEO	insulin glargine	Injection	206538	10,117,909	2036-11-01	Patent claims search
Sanofi-aventis U.s. Llc	TOUJEO	insulin glargine	Injection	206538	10,118,956	2035-11-30	Patent claims search
Sanofi-aventis U.s. Llc	TOUJEO	insulin glargine	Injection	206538	10,155,799	2035-07-16	Patent claims search

International Patents for TOUJEO

Country	Patent Number	Estimated Expiration
New Zealand	336548
World Intellectual Property Organization (WIPO)	2009067268
Russian Federation	2313362
Taiwan	I315201
European Patent Office	2118696
Japan	2012006979

Supplementary Protection Certificates for TOUJEO

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
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
CR 2017 00020	Denmark		PRODUCT NAME: INSULIN GLARGINE/LIXISENATID; REG. NO/DATE: EU/1/16/1157/001-004 20170113
2017030	Norway		PRODUCT NAME: INSULIN GLARGINE/LIXISENATIDE; REG. NO/DATE: EU/1/16/1157 20170125
300883	Netherlands		PRODUCT NAME: INSULIN GLARGINE/LIXISENATIDE; REGISTRATION NO/DATE: EU/1/16/1157 20170113
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

Market Dynamics and Financial Trajectory for TOUJEO: A Comprehensive Analysis

Last updated: September 23, 2025

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Introduction

Toujeo (insulin glargine [100 units/mL]) by Sanofi has established itself as a significant player in the long-acting basal insulin market. Launched to address the needs of patients requiring consistent glycemic control in type 1 and type 2 diabetes, Toujeo's market trajectory is shaped by evolving therapeutic landscapes, competitive forces, and broader healthcare dynamics. This analysis explores the market environment, growth drivers, challenges, and financial prospects of Toujeo within the global biologic drug ecosystem.

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Market Overview and Positioning

Toujeo is a proprietary, concentrated formulation of insulin glargine, intended for subcutaneous administration once daily. Its differentiation centers on delivering equivalent basal insulin efficacy with a smaller injection volume, potentially improving patient adherence. As of 2023, Toujeo primarily competes in the long-acting insulin segment—a lucrative sector estimated to reach approximately USD 14 billion by 2027, with a compound annual growth rate (CAGR) of around 7% [1].

Sanofi's dominance in this segment stems from its early market entry and extensive distribution network. However, intensifying competition from biosimilars, generics, and alternative delivery technologies poses strategic challenges. The positioning of Toujeo as a premium, concentrated insulin aims to carve a niche, supporting its long-term financial viability amidst a rapidly shifting landscape.

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Key Market Drivers

1. Growing Global Diabetes Prevalence

The International Diabetes Federation (IDF) reports over 537 million adults worldwide with diabetes—a figure projected to surpass 700 million by 2045 [2]. The surge in diabetes prevalence directly bolsters demand for insulin therapies, including Toujeo. High-income countries, led by the U.S. and Europe, exhibit stable or declining insulin use growth rates; however, emerging markets such as China and India are experiencing accelerated adoption, incentivized by increased healthcare access and rising awareness.

2. Technological and Formulation Advancements

Toujeo's concentrated formulation reduces injection volume, enhancing patient comfort and compliance—factors critical for long-term adherence. Additionally, Sanofi's integration of digital health tools, such as injection tracking and dose titration apps, aligns with the trend toward personalized medicine, potentially expanding its consumer base.

3. Therapeutic Shifts Toward Basal-Bolus Regimens

The preference for basal-bolus insulin regimes in complex diabetes management sustains the demand for long-acting insulins like Toujeo. Ongoing clinical trials demonstrating non-inferiority or superiority over alternatives provide confidence in its therapeutic positioning.

4. Favorable Reimbursement and Pricing Strategies

Sanofi employs targeted pricing models and secures insurance reimbursement in key markets. While price sensitivity remains a challenge, especially in emerging economies, strategic collaborations are expanding access, thus reinforcing revenue streams.

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Market Challenges and Competitive Landscape

1. Competition from Biosimilar Insulins

Generic and biosimilar formulations of insulin glargine—such as Mylan's Semglee and Novo Nordisk's Basaglar—are entering markets globally. These competitors often undercut pricing, pressuring Toujeo's market share and margins [3].

2. Patent Expiry and Legal Challenges

Despite Sanofi's ongoing patent protections, legal disputes and patent cliffs threaten exclusivity timelines. The expiration of key patents could accelerate biosimilar entry, reducing pricing power.

3. Emergence of Alternative Delivery Technologies

Innovations in insulin delivery—such as inhaled insulins (e.g., Afrezza) and non-invasive patches—potentially diminish reliance on injectable formulations, including Toujeo.

4. Market Saturation and Physician Preferences

While long-acting insulins remain a mainstay, shifting physician preferences toward newer agents with lower hypoglycemia risk or reduced injection frequency could constrain demand.

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Financial Trajectory and Revenue Projections

Historical Performance

Sanofi's diabetes segment, historically a substantial contributor to revenues—accounting for about USD 7.8 billion in 2022—has experienced modest growth, with insulins representing roughly 70% of this segment [4]. Toujeo's contribution, although significant, faces competitive pressures, which have tempered its growth.

Forecasted Growth and Revenue Opportunities

Analysts project a compounded annual growth rate of approximately 4-6% for Toujeo over the next five years, driven by increased adoption in emerging markets and incremental dosing adjustments in established markets. Additionally, Sanofi's strategic expansion into digital health solutions and personalized medicine could bolster subsequent uptake.

Pricing Strategies and Cost Dynamics

Price erosion underpinning biosimilar competition is a key risk factor, with potential reductions of 15-20% over the next three years. Nonetheless, premium formulations like Toujeo may retain value through differentiated benefits, supporting stable pricing. Cost containment initiatives and supply chain efficiencies further influence profit margins.

Impact of Regulatory and Market Access Policies

Strong regulatory pathways and favorable reimbursement in developed markets sustain revenue streams. Conversely, policy shifts towards cost containment—particularly in public healthcare systems—may exert downward pressure on prices and volume.

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Strategic Outlook and Investment Implications

Sanofi’s continual investment in innovative formulations, digital health integration, and global expansion builds a resilient ecosystem for Toujeo. The drug's financial trajectory hinges on its ability to defend against biosimilar erosion, sustain physician and patient preference, and adapt to technological advances.

Investors should monitor policy developments, biosimilar market entries, and emerging therapies that threaten traditional insulin paradigms. Strategic collaborations, patent defenses, and a focus on intensified patient engagement will be pivotal to safeguarding and enhancing Toujeo’s revenue trajectory.

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Key Market Trends Shaping Future Growth

• Digital and connected health solutions: Enhancing adherence and personalized dosing.
• Emerging market expansion: Targeting unmet needs and increasing insurance coverage.
• Biosimilar market entry: Necessitating aggressive pricing and value demonstration.
• Innovative delivery methods: Potentially disrupting injectable insulin markets.
• Regulatory landscape evolution: Facilitating or constraining market access.

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Key Takeaways

• Market expansion potential exists, driven by rising global diabetes prevalence, especially in emerging markets.
• Competitive pressures from biosimilars and new delivery technologies necessitate continuous innovation and strategic differentiation.
• Pricing and reimbursement strategies are critical; health policies favoring cost-efficiency threaten premium pricing models.
• Digital health integration offers avenues for growth, increased adherence, and patient-centric care.
• Patent protections and legal strategies are vital in delaying biosimilar entry, ensuring revenue continuity.

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FAQs

1. How does Toujeo differentiate itself from other long-acting insulins?
Toujeo's concentrated formulation allows for smaller injection volumes, which can enhance patient comfort and adherence. It also offers a distinct pharmacokinetic profile conducive to stable glycemic control.

2. What are the primary risks to Toujeo's market share?
Biosimilar competition, patent expirations, emerging delivery technologies, and shifting physician/patient preferences pose significant threats.

3. How significant is the emerging market in Toujeo's growth prospects?
Very significant. Countries like China and India are experiencing rapid diabetes prevalence increases, with expanding healthcare infrastructure and insurance coverage, presenting substantial growth opportunities.

4. What role do digital health tools play in Toujeo's future?
They facilitate better patient adherence, dose management, and real-time monitoring, strengthening the value proposition and encouraging long-term usage.

5. What strategic actions should Sanofi consider to sustain Toujeo’s financial trajectory?
Investing in innovation, safeguarding patents, expanding access via collaborations, integrating digital health, and differentiating through clinical benefits are essential.

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References

1. Markets and Markets, "Diabetes Care Devices Market," 2022.
2. International Diabetes Federation, "IDF Diabetes Atlas," 10th Edition, 2021.
3. Evaluate Pharma; "Biosimilars in Insulin Market," 2022.
4. Sanofi Annual Report 2022.

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