TRESIBA Drug Profile

Summary for Tradename: TRESIBA

High Confidence Patents:	53
Applicants:	1
BLAs:	1
Drug Prices:	Drug price information for TRESIBA
Recent Clinical Trials:	See clinical trials for TRESIBA

See drug prices for TRESIBA

Recent Clinical Trials for TRESIBA

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Gan and Lee Pharmaceuticals, USA	PHASE1
Profil Institut fr Stoffwechselforschung GmbH	PHASE1
Novo Nordisk A/S	PHASE1

See all TRESIBA clinical trials

Pharmacology for TRESIBA

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 TRESIBA Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for TRESIBA 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
Novo Nordisk Inc.	TRESIBA	insulin degludec	Injection	203314		2035-04-30	DrugPatentWatch analysis and company disclosures
Novo Nordisk Inc.	TRESIBA	insulin degludec	Injection	203314		2035-08-27	DrugPatentWatch analysis and company disclosures
Novo Nordisk Inc.	TRESIBA	insulin degludec	Injection	203314		2036-03-08	DrugPatentWatch analysis and company disclosures
Novo Nordisk Inc.	TRESIBA	insulin degludec	Injection	203314		2026-07-17	DrugPatentWatch analysis and company disclosures
Novo Nordisk Inc.	TRESIBA	insulin degludec	Injection	203314		2037-11-15	DrugPatentWatch analysis and company disclosures
Novo Nordisk Inc.	TRESIBA	insulin degludec	Injection	203314		2037-11-17	DrugPatentWatch analysis and company disclosures
Novo Nordisk Inc.	TRESIBA	insulin degludec	Injection	203314		2037-02-24	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for TRESIBA 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
Novo Nordisk Inc.	TRESIBA	insulin degludec	Injection	203314		2034-04-30	Patent claims search
Novo Nordisk Inc.	TRESIBA	insulin degludec	Injection	203314		2038-06-27	Patent claims search
Novo Nordisk Inc.	TRESIBA	insulin degludec	Injection	203314		2037-05-24	Patent claims search
Novo Nordisk Inc.	TRESIBA	insulin degludec	Injection	203314		2036-12-05	Patent claims search
Novo Nordisk Inc.	TRESIBA	insulin degludec	Injection	203314		2037-10-13	Patent claims search
Novo Nordisk Inc.	TRESIBA	insulin degludec	Injection	203314		2038-11-02	Patent claims search
Novo Nordisk Inc.	TRESIBA	insulin degludec	Injection	203314		2036-10-21	Patent claims search

International Patents for TRESIBA

Country	Patent Number	Estimated Expiration
European Patent Office	2197524
World Intellectual Property Organization (WIPO)	2011112229
European Patent Office	4056173
Brazil	112016015355
Poland	2726141
Canada	2903769
World Intellectual Property Organization (WIPO)	2009045596

Supplementary Protection Certificates for TRESIBA

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
300596	Netherlands		PRODUCT NAME: INSULINE DEGLUDEC; NATIONAL REGISTRATION NO/DATE: EU/1/12/807/004 20130123; FIRST REGISTRATION: EU EU/1/12/807/001 20130123
C02107069/02	Switzerland		PRODUCT NAME: INSULIN DEGLUDEC + INSULIN ASPART; REGISTRATION NO/DATE: SWISSMEDIC 62648 12.09.2013
C02107069/01	Switzerland		PRODUCT NAME: INSULIN DEGLUDEC; SWISSMEDIC-ZULASSUNG, 62562 12.03.2013
132013902172094	Italy		PRODUCT NAME: INSULINA DEGLUDEC/INSULINA ASPART(RYZODEG); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/12/806/001-004-005-007-008, 20130121
C 2013 022	Romania		PRODUCT NAME: COMBINATIE DE INSULINA DEGLUDEC SI INSULINA ASPART IN TOATEFORMELE SALE ASA CUM SUNT PROTEJATE IN BREVETUL DEBAZA; NATIONAL AUTHORISATION NUMBER: EU/1/12/806/001,EU/1/12/806/004,EU/1/12/806/005,EU/1/12/806/007,00; DATE OF NATIONAL AUTHORISATION: 20130121; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/12/806/001, EU/1/12/806/004, EU/1/12/806/005, EU/1/12/806/007, 00; DATE OF FIRST AUTHORISATION IN EEA: 20130121
13C0035	France		PRODUCT NAME: INSULINE DEGLUDEC; REGISTRATION NO/DATE: EU/1/12/807/001 20130121
300597	Netherlands		PRODUCT NAME: INSULINE DEGLUDEC EN INSULINE ASPART; REGISTRATION NO/DATE: EU/1/12/806/001 20130123

Market Dynamics and Financial Trajectory for the Biologic Drug: Tresiba

Last updated: September 23, 2025

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Introduction

Tresiba, developed by Novo Nordisk, is a long-acting basal insulin analogue positioned to revolutionize diabetes management. Launched globally, its market dynamics are shaped by evolving healthcare landscapes, technological innovation, regulatory environments, and competitive forces. This analysis examines Tresiba's current market position, growth drivers, challenges, and future financial trajectory to inform stakeholder decisions.

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Product Overview

Tresiba (insulin degludec) was approved by the U.S. Food and Drug Administration (FDA) in September 2015 and by the European Medicines Agency (EMA) earlier, in 2013. It offers an ultra-long duration of action (~42 hours), enabling once-daily dosing with increased flexibility and a reduced risk of hypoglycemia compared to older basal insulins [1].

The product caters predominantly to Type 1 and Type 2 diabetes patients who require basal insulin therapy. Its unique pharmacokinetics aims to improve glycemic control, reduce dosing complexity, and enhance patient adherence—factors that collectively influence its adoption and market penetration.

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Market Dynamics

1. Growth Drivers

• Rising Diabetes Prevalence: The global incidence of diabetes, currently estimated at over 537 million adults, sustains a substantial demand for insulin therapies. The International Diabetes Federation projects this to reach 643 million by 2030, amplifying Tresiba’s market potential [2].

• Preference for Long-Acting Insulin: Clinical guidelines favor basal insulins that minimize hypoglycemic episodes and provide consistent glucose control. Tresiba’s ultra-long duration and flexibility address these needs, encouraging prescriber preference.

• Innovation and Differentiation: Tresiba's pharmacokinetic profile offers a competitive edge over traditional insulins like insulin glargine and detemir. Its potential to reduce hypoglycemia risk and allow flexible dosing enhances its appeal, especially in patient-centric care models.

• Regulatory Approvals and Expanding Indications: Continued approvals, including for use in pediatric populations in some markets, extend Tresiba’s reach, opening avenues for increased sales.

• Manufacturing Efficiency and Market Penetration Strategies: Novo Nordisk’s robust supply chain and targeted marketing foster deeper penetration into developing markets and specialty segments.

2. Market Challenges

• Intense Competition: Tresiba faces competition from biosimilar insulins and other long-acting analogues such as Sanofi’s Toujeo and Lilly’s Basaglar. Although biosimilars have gained a foothold, Tresiba’s differentiated profile maintains its premium positioning.

• Pricing Pressures: Governments and payers across markets pursue cost containment, exerting downward pressure on insulin prices. The affordability challenge impacts margins and sales volume.

• Physician and Patient Acceptance: Despite its benefits, some prescribers and patients remain loyal to established insulins. Adherence issues, misconceptions, and market inertia slow penetration.

• Regulatory and Patent Landscape: Patent expiries, potential biosimilar entries, and evolving regulatory standards influence market exclusivity and pricing strategies.

3. Market Penetration and Adoption Trends

In North America, Tresiba has captured approximately 15%–20% of the long-acting insulin market segment, with growth propelled by increased awareness and insurtech initiatives that promote personalized management [3].

In Europe and Asia-Pacific, adoption varies, influenced by healthcare infrastructure, reimbursement policies, and physician practices. Notably, Japan and China exhibit rapidly expanding markets for basal insulins, driven by rising diabetes prevalence and modernization of healthcare delivery.

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Financial Trajectory Analysis

1. Revenue Trends

Post-launch, Tresiba has demonstrated consistent revenue growth. Novo Nordisk’s 2022 earnings report indicated that Tresiba contributed approximately 25% of the company's global insulin sales, reflecting a steady upward trajectory [4]. This growth is predicated on increased market share in mature markets and burgeoning demand in emerging economies.

2. Revenue Drivers

• Volume Growth: An expanding diabetic population and increased patient adherence contribute to higher demand.

• Market Expansion: Entry into new geographic markets and endorsement by clinical guidelines bolster revenue streams.

• Pricing Strategies: Premium pricing sustains profit margins but is balanced against payer negotiations. Novo Nordisk employs tiered pricing to access emerging markets.

3. Future Revenue Forecasts

Analysts project Tresiba’s sales to reach USD 3.5–4.0 billion globally by 2025, driven by:

• Continued adoption in Type 2 diabetes management
• Introduction of fixed-dose combinations and new delivery devices
• Strategic partnerships and licensing arrangements to penetrate low-income markets

Furthermore, the ongoing patent litigations and biosimilar developments could influence market exclusivity, impacting revenue potential.

4. Investment and R&D Outlook

Novo Nordisk’s commitment to innovation suggests ongoing pipeline enhancements for Tresiba, including next-generation formulations and novel delivery systems, potentially expanding its user base and revenue contributions.

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Regulatory and Competitive Landscape

The regulatory environment remains favorable, with continuous updates emphasizing safety and efficacy standards. Patent landscapes, however, pose looming threats: biosimilar competitors in the U.S. and Europe could erode market share post-patent expiry (expected around 2027-2028).

In addition, emergent competitors utilize advanced biosimilar platforms and digital health integrations to gain footholds in the diabetes market.

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Market Opportunities and Risks

• Digital Health Integration: Wearables and smart insulin pens embedded with dose-tracking capabilities present opportunities for Tresiba to enhance adherence and outcomes, potentially translating into increased sales.

• Expanding into Type 1 Diabetes: While predominantly used for Type 2, increasing acceptance among Type 1 patients can further propel growth.

• Risks: Biosimilar entry, pricing pressures, regulatory delays, and patient preference shifts toward oral or non-insulin therapies pose ongoing risks.

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Key Financial Trajectory Summary

Parameter	Current Status	Projected Outlook (2023-2025)
Global Sales	USD 2.5 Billion (2022)	USD 3.5–4.0 Billion
Market Share (Long-acting Insulin)	15-20% (North America)	Incremental growth to 25%
Revenue Growth Rate	8-12% annually	10-15% driven by market expansion
Patent Expiry Impact	Expected in late 2020s	Biosimilar competition influencing margins

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Conclusion

Tresiba’s market dynamics are favorable owing to its differentiated pharmacology and expanding global diabetes burden. Strategic positioning, innovation, and market expansion will underpin its continued financial growth. However, competitive pressures, pricing constraints, and patent expiries necessitate proactive adaptation.

Investors and stakeholders should monitor biosimilar developments, healthcare policy shifts, and technological integrations to sustain profitability and market relevance.

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Key Takeaways

• Robust Growth Driver: Increasing global diabetes prevalence and preference for long-acting, flexible insulin therapies underpin Tresiba's expansion prospects.
• Market Penetration: Emerging markets and digital health tools are key opportunities for increased adoption.
• Competitive Risks: Biosimilar competition and pricing pressures threaten revenue stability post-patent expiry.
• Innovation Focus: Ongoing R&D and device advancements are crucial for maintaining strategic advantage.
• Financial Outlook: Revenue is projected to grow steadily, with potential for acceleration through market expansion and pipeline development.

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FAQs

1. When will Tresiba face biosimilar competition, and how will it affect its market share?
Biosimilar versions are expected around 2027–2028, given patent expiries. Entry of biosimilars could significantly reduce Tresiba’s market share and margins, prompting Novo Nordisk to innovate further and diversify its insulin portfolio.

2. How does Tresiba compare with other long-acting insulins in terms of efficacy and safety?
Tresiba offers a longer, more stable pharmacokinetic profile, reducing hypoglycemia risk and providing dosing flexibility. Clinical studies confirm comparable or superior efficacy with a favorable safety profile relative to competitors [1].

3. What role will digital health play in Tresiba's future market performance?
Digital health tools such as smart insulin pens and continuous glucose monitoring can enhance adherence and real-time management, potentially driving increased Tresiba uptake and user engagement.

4. Are there emerging markets with significant growth potential for Tresiba?
Yes, markets like China and India, experiencing rapid diabetes prevalence growth and evolving healthcare systems, offer considerable expansion prospects through tailored pricing and local partnerships.

5. How does regulatory environment influence Tresiba’s market strategy?
Regulatory approvals determine geographic access; evolving standards, especially regarding biosimilar approval pathways, could impact timing and competitiveness, requiring strategic navigation by Novo Nordisk.

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References

[1] Novo Nordisk. (2015). FDA approves Tresiba for adults with diabetes.
[2] International Diabetes Federation. (2022). Diabetes Atlas.
[3] MarketWatch. (2022). North American long-acting insulin market share analysis.
[4] Novo Nordisk. (2022). Annual Report 2022.

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Note: All data are projections based on current market analyses, regulatory landscapes, and company disclosures as of 2023.