Insulin detemir - Biologic Drug Details

Summary for insulin detemir

Tradenames:	1
High Confidence Patents:	14
Applicants:	1
BLAs:	1
Suppliers: see list	2
Recent Clinical Trials:	See clinical trials for insulin detemir

Recent Clinical Trials for insulin detemir

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Novo Nordisk A/S	PHASE4
Novo Nordisk A/S	PHASE1
Loyola University	PHASE3

See all insulin detemir clinical trials

Pharmacology for insulin detemir

Ingredient-type	Insulin
Established Pharmacologic Class	Insulin Analog

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 detemir Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for insulin detemir 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.	LEVEMIR	insulin detemir	Injection	021536	10,220,155	2026-07-17	DrugPatentWatch analysis and company disclosures
Novo Nordisk Inc.	LEVEMIR	insulin detemir	Injection	021536	10,357,616	2037-11-17	DrugPatentWatch analysis and company disclosures
Novo Nordisk Inc.	LEVEMIR	insulin detemir	Injection	021536	10,376,652	2037-02-24	DrugPatentWatch analysis and company disclosures
Novo Nordisk Inc.	LEVEMIR	insulin detemir	Injection	021536	11,097,063	2039-01-17	DrugPatentWatch analysis and company disclosures
Novo Nordisk Inc.	LEVEMIR	insulin detemir	Injection	021536	11,311,679	2039-06-25	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for insulin detemir 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.	LEVEMIR	insulin detemir	Injection	021536	10,016,338	2036-12-20	Patent claims search
Novo Nordisk Inc.	LEVEMIR	insulin detemir	Injection	021536	10,241,117	2038-04-27	Patent claims search
Novo Nordisk Inc.	LEVEMIR	insulin detemir	Injection	021536	10,251,957	2032-06-01	Patent claims search
Novo Nordisk Inc.	LEVEMIR	insulin detemir	Injection	021536	10,265,291	2037-02-13	Patent claims search
Novo Nordisk Inc.	LEVEMIR	insulin detemir	Injection	021536	10,328,157	2037-02-03	Patent claims search

International Patents for insulin detemir

Country	Patent Number	Estimated Expiration
Japan	2009050713
Canada	2584762
Poland	374182
Spain	2163451
Japan	3917333

Supplementary Protection Certificates for insulin detemir

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
SZ 50/1999	Austria		PRODUCT NAME: INSULIN ASPART
0491022-0	Sweden		PRODUCT NAME: N EPSILONB29 MYRISTOYL- ELLER N EPSILONB29 TETRADEKANOYL-DES(B30) HUMANT INSULIN
PA2004005,C0792290	Lithuania		PRODUCT NAME: INSULIN DETEMIR; REGISTRATION NO/DATE: EU/1/04/278/001, EU/1/04/278/002, EU/1/04/278/003, EU/1/04/278/004, EU/1/04/278/005, EU/1/04/278/006, EU/1/04/278/007, EU/1/04/278/008, EU/1/04/278/00 20040601
C990042	Netherlands		PRODUCT NAME: INSULIN ASPART; REGISTRATION NO/DATE: EU/1/99/119/001 - EU/1/99/119/005 19990907
SPC015/2004	Ireland		SPC015/2004, 20060131, EXPIRES: 20181109

Market Dynamics and Financial Trajectory for Insulin Detemir

Last updated: December 15, 2025

Summary

Insulin detemir, a long-acting basal insulin analog, has become a vital therapeutic for managing diabetes mellitus, mainly Type 1 and Type 2. Developed by Novo Nordisk, its market penetration is driven by rising diabetes prevalence, evolving therapeutic guidelines favoring basal insulins, and competitive innovations. This analysis explores the current market landscape, financial trajectories, key competitive factors, regulatory environment, and future growth prospects.

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What Are the Market Fundamentals for Insulin Detemir?

Global Diabetes Epidemic and Market Drivers

Parameter	Details
Global diabetic population (2022)	Approximately 537 million adults; projected to reach 643 million by 2030 [1].
Growth rate	~3.4% annually globally [1].
Regional distribution	Predominantly North America, Europe, Asia-Pacific.
Diagnosis and treatment rate	Underdiagnosed globally; treatment adherence varies.

Key Market Drivers:

• Increasing diabetes prevalence.
• Shift towards basal insulins for convenience and glycemic control.
• Better patient compliance with long-acting insulins.
• Evolving clinical guidelines favoring basal insulin analogs over human insulins.

Market Impact of Rising Diabetes:

• The global insulin market was valued at approximately $25 billion in 2022, with basal insulins accounting for nearly 70% [2].
• Insulin detemir holds a significant share within long-acting insulins.

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What Is the Competitive Landscape for Insulin Detemir?

Manufacturer	Product Name	Market Share (2022)	Key Competitors
Novo Nordisk	Levemir (insulin detemir)	40%	Eli Lilly, Sanofi, Biocon, Humulin
Eli Lilly	Basaglar (biosimilar insulin glargine)	15%	Novo Nordisk, Sanofi
Sanofi	Lantus (insulin glargine)	25%	Novo Nordisk, Lilly
Others	Biosimilar and generic insulins	20%	Various local players

Patent and Biosimilar Dynamics

• The original patent for insulin detemir expired around 2017-2018 globally, sparking biosimilar entry.
• Novo Nordisk maintains a strong position via patent protections on device formulations and delivery mechanisms.
• Biosimilars, primarily from Lilly (Basaglar) and emerging entrants from China and India, pose competitive challenges.

Pricing Strategies

Factor	Details
Originator Price (US, 2023)	~$300–$400 per month (depending on dosage & insurer)
Biosimilar Price Discount	15–30% relative to originator
Reimbursement and Coverage	Varies by region; insurers prefer long-acting insulins due to better adherence and glycemic control.

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What Are the Financial Trajectories for Insulin Detemir?

Revenue and Sales Trends

Year	Global Sales (USD Billion)	Growth Rate	Notes
2018	~$2.3	N/A	Peak prior to biosimilar competition
2020	~$2.1	-8.7%	Due to biosimilar entry and pricing pressures
2022	~$2.4	+14.3%	Stabilization, market expansion
2025 (Forecast)	~$3.0	8-12% CAGR	Driven by increased diabetes prevalence and biosimilar adoption

Revenue Segmentation

• North America: ~50%
• Europe: ~25%
• Asia-Pacific: ~15%
• Rest of World: ~10%

Profitability Outlook

• Margins have decreased slightly, reflecting competitive pressure.
• Cost optimization and biosimilar sourcing are critical to maintaining profitability.
• Investment in formulation improvements and delivery devices offers growth avenues.

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What Are the Regulatory and Policy Influences?

Regulatory Milestones

• FDA Approval (2009): For insulin detemir, establishing a clear pathway for biosimilars.
• EMA Approvals: Similar timelines with guidelines encouraging biosimilar adoption.
• Biosimilar Pathways: Stringent demonstrating of biosimilarity, interchangeability criteria, and naming conventions.

Pricing and Reimbursement Policies

• Countries like the US, EU, and Japan have implemented policies favoring biosimilar use to lower healthcare costs.
• Incentivized substitution in some regions post-approval to improve affordability.

Impact of Healthcare Policies

Policy	Effect on Insulin Detemir
Cost-saving measures	Accelerates biosimilar adoption, pressure on originator pricing.
Value-based reimbursement models	Push for demonstrating device and formulation advantages.
Patent litigations and settlements	Delay or enable biosimilar market entry.

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What Is the Future Outlook for Insulin Detemir?

Growth Opportunities

• Emerging Markets: Rapid growth driven by increasing diabetes rates and expanding healthcare infrastructure.
• Biosimilar Penetration: Greater biosimilar availability could reduce costs and expand access.
• Innovation in Delivery Devices: Smart pens, connected devices, and patch formulations could augment market share.
• Therapeutic Advances: Comparisons with newer ultra-long-acting insulins (e.g., insulin degludec) may influence prescribing.

Challenges

• Market Competition: Insulin glargine and ultra-long-acting insulins offer alternative options.
• Pricing Pressures: Globally, healthcare systems aim to reduce costs.
• Regulatory Barriers: Biosimilar approval and interchangeability issues vary across markets.
• Patient Preferences: Increased preference for simplified regimens and digital health tools.

Projected Market Growth Graph

Illustrative projection of global insulin (including detemir) market value (2022–2030):

Year	Market Value (USD Billion)	Compound Annual Growth Rate (2022–2030)
2022	25	N/A
2025	32–35	~8%
2030	45–50	~10%

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What Is the Impact of Competitive Innovations?

Innovation	Potential Effect	Key Players Involved
Ultra-long-acting insulins	May diminish demand for insulin detemir if preferred for convenience.	Novo Nordisk (insulin degludec), Lilly (insulin glargine U-300)
Insulin pumps and CGMS	Shift focus to device-based therapy; possibly reduce injectable reliance.	Medtronic, Tandem, Abbott
Digital and connected health tools	Enhance adherence, optimize regimens, and improve outcomes.	Various startups and established pharma firms

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Comparison Table: Insulin Detemir vs. Alternatives

Parameter	Insulin Detemir	Insulin Glargine	Ultra-Long-Acting Insulin (Degludec)
Duration of Action	Up to 24 hours	24 hours	>42 hours
Dosing Flexibility	Once or twice daily	Once daily	Once daily
Onset of Action	~1-2 hours	~1 hour	Similar to glargine
Risk of Hypoglycemia	Lower than NPH, comparable to glargine	Similar to detemir	Possibly lower
Price Range (USD/month)	$300–$400	$250–$350	$350–$500

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Key Takeaways

• Growing Diabetes Prevalence: The global rise in diabetes will sustain demand for basal insulins like insulin detemir through 2030.
• Biosimilar Penetration: Post-patent expiration has fostered significant biosimilar competition, pressuring prices but expanding access, especially in emerging markets.
• Market Concentration: Novo Nordisk maintains a dominant share via brand loyalty, device integration, and patent defenses.
• Pricing and Policy Environment: Evolving policies favor biosimilar adoption, with cost-containment measures influencing future revenues.
• Innovation and Digital Health: Advances in delivery systems and personalized medicine present growth avenues, but also challenge the traditional basal insulin market.
• Competitive Landscape: While insulin detemir remains relevant, newer ultra-long-acting insulins and smart delivery devices threaten its market share.

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FAQs

1. How does biosimilar insulin detemir impact the market?
Biosimilar versions from Lilly and others have introduced price competition, leading to decreased prices and expanded market access, particularly in cost-sensitive regions. However, patent litigations and regulatory pathways impact the pace of biosimilar adoption.

2. What factors influence the pricing of insulin detemir globally?
Pricing is affected by patent status, biosimilar entry, healthcare policies, reimbursement frameworks, and negotiated discounts with payers. Developed markets tend to have higher prices, moderated by insurance and government programs.

3. What are the key differentiators of insulin detemir compared to newer insulins?
Detemir's established efficacy, long history of use, and flexible dosing contribute to its ongoing clinical utility. However, ultra-long-acting insulins offer prolonged action and convenience, potentially replacing detemir in certain cases.

4. How do regulations in major markets affect insulin detemir’s market trajectory?
Stringent biosimilar guidelines in the EU, US, and Japan facilitate safe entry but can delay biosimilar approvals and substitutions, influencing market share and pricing strategies.

5. What future growth strategies are essential for manufacturers of insulin detemir?
Focus on expanding access in emerging markets, investing in formulation improvements, enhancing delivery devices, and leveraging digital health platforms will be critical for sustained growth.

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References

[1] International Diabetes Federation. IDF Diabetes Atlas, 2022.
[2] Grand View Research. Insulin Market Analysis, 2022.
[3] Novo Nordisk Annual Report 2022.
[4] US Food & Drug Administration. Biosimilar Approval Pathways, 2021.
[5] European Medicines Agency. Biosimilar Guideline, 2019.