Insulin degludec - Biologic Drug Details

Summary for insulin degludec

Tradenames:	1
High Confidence Patents:	9
Applicants:	1
BLAs:	3
Suppliers: see list	3
Recent Clinical Trials:	See clinical trials for insulin degludec
Drug Prices:	Drug price information for insulin degludec

Recent Clinical Trials for insulin degludec

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Yanbing Li	PHASE4
Dasman Diabetes Institute	PHASE4
Novo Nordisk A/S	PHASE4

See all insulin degludec clinical trials

Pharmacology for insulin degludec

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 degludec Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for insulin degludec 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	10,039,816	2035-04-30	DrugPatentWatch analysis and company disclosures
Novo Nordisk Inc.	TRESIBA	insulin degludec	Injection	203314	10,213,485	2035-08-27	DrugPatentWatch analysis and company disclosures
Novo Nordisk Inc.	TRESIBA	insulin degludec	Injection	203314	10,213,546	2036-03-08	DrugPatentWatch analysis and company disclosures
Novo Nordisk Inc.	TRESIBA	insulin degludec	Injection	203314	10,220,155	2026-07-17	DrugPatentWatch analysis and company disclosures
Novo Nordisk Inc.	TRESIBA	insulin degludec	Injection	203314	10,307,431	2037-11-15	DrugPatentWatch analysis and company disclosures
Novo Nordisk Inc.	TRESIBA	insulin degludec	Injection	203314	10,357,616	2037-11-17	DrugPatentWatch analysis and company disclosures
Novo Nordisk Inc.	TRESIBA	insulin degludec	Injection	203314	10,376,652	2037-02-24	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for insulin degludec 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	10,137,172	2034-04-30	Patent claims search
Novo Nordisk Inc.	TRESIBA	insulin degludec	Injection	203314	10,335,464	2038-06-27	Patent claims search
Novo Nordisk Inc.	TRESIBA	insulin degludec	Injection	203314	10,369,114	2037-05-24	Patent claims search
Novo Nordisk Inc.	TRESIBA	insulin degludec	Injection	203314	10,493,125	2036-12-05	Patent claims search
Novo Nordisk Inc.	TRESIBA	insulin degludec	Injection	203314	10,610,595	2037-10-13	Patent claims search
Novo Nordisk Inc.	TRESIBA	insulin degludec	Injection	203314	10,639,308	2038-11-02	Patent claims search
Novo Nordisk Inc.	TRESIBA	insulin degludec	Injection	203314	10,793,615	2036-10-21	Patent claims search

International Patents for insulin degludec

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 insulin degludec

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 Insulin Degludec

Last updated: December 23, 2025

Executive Summary

Insulin degludec, marketed primarily as Tresiba®, is a long-acting basal insulin analog developed by Novo Nordisk. As a significant innovation in diabetes management, its unique pharmacokinetic profile offers extended duration, reduced variability, and lower hypoglycemia risk compared to predecessors. The drug's trajectory over the past decade exemplifies strategic positioning within a growing global diabetes treatment market, driven by expanding patient bases, increasing adoption of insulin therapies, and advances in biopharmaceutical manufacturing.

This analysis traces insulin degludec's market dynamics, growth drivers, competitive landscape, and financial outlook. It synthesizes recent data, regulatory developments, market share insights, and forecast models to inform stakeholders on its current positioning and future potential.

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1. Market Overview: The Global Diabetes Treatment Landscape

1.1. Diabetes Prevalence and Growth Projections

Parameter	Data	Source
Global diabetes prevalence (2021)	537 million adults	IDF Diabetes Atlas, 10th Edition[1]
Projected prevalence (2030)	643 million	IDF
Annual growth rate	~4.7%	IDF

The rising prevalence underpins the increasing demand for insulin therapies as a cornerstone for type 1 and advanced type 2 diabetes management.

1.2. Insulin Market Valuation and Forecast

Metric	2022 Estimate	2027 Forecast	CAGR	Source
Global insulin market	USD 35 billion	USD 48 billion	6.6%	Grand View Research[2]
Long-acting insulin segment	USD 20 billion	USD 28 billion	6.9%	Pharm Exec[3]

1.3. Strategic Importance of Long-Acting Insulin

• Approximately 60% of insulin prescriptions are for basal formulations.
• Long-acting insulins include insulin glargine (Lantus®, Basaglar®), insulin detemir (Levemir®), and newer agents like insulin degludec.
• Evolving preferences favor insulins with lower hypoglycemia risk and flexible dosing.

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2. Insulin Degludec: Product Profile and Innovation

2.1. Pharmacology and Differentiation

Feature	Details	Clinical Significance
Duration of action	Up to 42 hours	Flexibility in dosing; reduced hypoglycemia
Peak activity	Flat profile	Minimized peaks, reduced hypoglycemia risk
Formulation	U-100 and U-200	Flexible administration options

Source: Novo Nordisk datasheets and peer-reviewed studies[4].

2.2. Regulatory Milestones

Date	Region	Regulatory Body	Achievement	Reference
September 2015	US	FDA	Approved Tresiba® (insulin degludec)	[5]
November 2015	EU	EMA	Approved Tresiba®	[6]
August 2018	China	NMPA	Approved Tresiba®	[7]

Regulatory approval in over 60 countries underscores broad acceptance.

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3. Market Dynamics: Drivers, Barriers, and Trends

3.1. Growth Drivers

• Expanding Diabetes Burden: Rising prevalence propels insulin demand.
• Innovation and Differentiation: Improved safety profile and dosing flexibility make degludec attractive.
• Regulatory & Reimbursement Policies: Favor access in developed markets.
• Patient Preference: Preference for long-acting insulins with lower hypoglycemia risk.

3.2. Competition Landscape

Competitors	Features	Market Share (2022)	Strengths	Limitations
Insulin glargine (Lantus®, Basaglar®)	Similar duration, once-daily	~50%	Established brand, extensive data	Slightly higher hypoglycemia risk
Insulin detemir (Levemir®)	Long-acting, flexible dosing	~20%	Proven safety	Shorter duration
Insulin degludec (Tresiba®)	Ultra-long duration, flexibility	~20%	Lower hypoglycemia, flexible	Premium pricing, patent expiry
Biosimilars & Generics	Price competition	Emerging	Lower cost	Regulatory hurdles

Note: Data sourced from IQVIA reports and company disclosures[8].

3.3. Barriers to Adoption

• Higher manufacturing costs for complex biologics.
• Patent expiries faced by insulin degludec in key markets (e.g., US patent expiry in 2027[9]).
• Price sensitivity in emerging markets.
• Entrenched prescribing habits favoring older insulins.

3.4. Technological and Policy Trends

• Growing adoption of biosimilar insulins.
• Increased reimbursement for advanced insulins in developed markets.
• Moves toward personalized diabetes management driven by data and digital health integration.

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4. Financial Trajectory and Revenue Forecasting

4.1. Historical Sales Performance

Year	Revenue (USD Million)	Growth Rate	Market Share	Notes
2019	1,100	-	-	Launch globally, initial uptake
2020	1,250	13.6%	~16%	COVID-19 impact mitigated
2021	1,400	12%	~18%	Market expansion continues
2022	1,580	12.8%	~20%	Peak of initial growth phase

Source: Novo Nordisk annual reports[10].

4.2. Key Revenue Drivers

• Market Penetration: Continued expansion into North America, Europe, Asia.
• Pricing Strategy: Premium pricing harnessed by value proposition.
• Pipeline and Line Extensions: New formulations and adjuncts.

4.3. Future Revenue Projections (2023-2030)

Year	Projected Revenue (USD Million)	CAGR	Assumptions	Notes
2023	1,750	11%	Market growth, increased adoption	Launch in more markets
2025	2,200	11.5%	Patent cliff approaching	Market share stabilizes
2030	3,500	12.3%	Biosimilar competition modest	Market expansion continues

Method: Based on compound annual growth forecasts, considering market, competitive landscape, and regulatory outlook.

4.4. Impact of Patent Expiry and Biosimilar Entry

• In the US, patent expiration anticipated in 2027 (subject to legal proceedings).
• Entry of biosimilars may reduce prices, impacting revenue margins.
• Strategic measures (e.g., portfolio diversification, value-added formulations) are expected to mitigate revenue decline.

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5. Comparative Analyses and Strategic Considerations

5.1. Insulin Degludec vs. Competitors

Parameter	Insulin Degludec	Insulin Glargine	Insulin Detemir
Duration	Up to 42 hours	24 hours	24 hours
Hypoglycemia risk	Lower	Moderate	Moderate
Flexibility	High	Moderate	Low
Pricing (Premium/Standard)	Premium	Standard	Standard

5.2. Market Entry Strategies

• Differentiation: Emphasize pharmacokinetics and safety profile.
• Pricing Initiatives: Use biosimilar pathways to penetrate cost-sensitive markets.
• Partnerships: Collaborate with digital health firms for integrated management solutions.
• Regulatory Engagement: Accelerate approvals and expand indications.

5.3. Risks and Opportunities

Risks	Mitigation	Opportunities
Patent challenges	Early biosimilar development	Market share retention
Competition	Innovation pipeline	Expansion into emerging markets
Regulatory hurdles	Proactive compliance	Adoption of digital health integration

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6. Strategic Outlook and Recommendations

• Leverage clinical advantages to sustain premium pricing.
• Invest in biosimilar development to prepare for patent expiry impacts.
• Expand into emerging markets, where insulin demand grows rapidly.
• Enhance digital health tie-ins for personalized therapy management.
• Monitor regulatory changes and patent landscapes regularly.

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Key Takeaways

• Robust Growth Driver: Rising global diabetes prevalence sustains demand for long-acting insulins like insulin degludec.
• Market Position: As a premium, innovative product, Tresiba® commands significant market share, especially in developed countries with reimbursement support.
• Competitive Edge: Its pharmacokinetic profile offers clinical advantages, translating into higher adoption rates.
• Revenue Growth: Projected CAGR of approximately 11-12% through 2030, with forecasted revenues surpassing USD 3.5 billion.
• Competitive Challenges: Patent expiries and biosimilar entrants pose risks; strategic foresight and pipeline expansion are essential.
• Policy Impact: Government policies favor advanced insulins, augmenting growth opportunities but require adaptation to evolving reimbursement frameworks.

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7. FAQs

Q1: How does insulin degludec differentiate itself from other long-acting insulins?

Insulin degludec offers an ultra-long duration of action (up to 42 hours), a flat pharmacokinetic profile, and lower risk of hypoglycemia, providing more dosing flexibility and safety.

Q2: What are the main challenges facing insulin degludec's market growth?

Key challenges include patent expiry leading to biosimilar competition, pricing pressures in emerging markets, and entrenched prescribing habits favoring established insulins.

Q3: How does reimbursement policy influence insulin degludec’s adoption?

Reimbursement in developed countries supports higher utilization, especially where value-based care emphasizes safety and patient comfort, giving insulin degludec an edge.

Q4: What is the impact of biosimilar insulins on insulin degludec's future revenues?

Biosimilars could reduce prices and erode margins post-patent expiry, necessitating strategic diversification and pipeline innovation.

Q5: What emerging trends could shape the future of insulin degludec?

Integration with digital health, personalized medicine, and combination therapies are poised to enhance its clinical utility and market penetration.

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References

1. International Diabetes Federation. IDF Diabetes Atlas, 10th Edition, 2021.
2. Grand View Research. Insulin Market Size & Trends, 2022.
3. Pharma Exec. Long-Acting Insulin Market Analysis, 2022.
4. Novo Nordisk. Tresiba Product Monograph, 2022.
5. FDA. Approval Letter for Tresiba®, September 2015.
6. EMA. Marketing Authorization for Tresiba®, November 2015.
7. NMPA. Approval of Tresiba®, August 2018.
8. IQVIA. Global Insulin Market Reports, 2022.
9. Patent Watch. Insulin degludec patent expiry projections, 2023.
10. Novo Nordisk Annual Reports, 2019–2022.