Insulin degludec and insulin aspart - Biologic Drug Details

Summary for insulin degludec and insulin aspart

Tradenames:	1
High Confidence Patents:	9
Applicants:	1
BLAs:	1

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 and insulin aspart Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for insulin degludec and insulin aspart 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.	RYZODEG 70/30	insulin degludec and insulin aspart	Injection	203313	10,232,044	2034-08-21	DrugPatentWatch analysis and company disclosures
Novo Nordisk Inc.	RYZODEG 70/30	insulin degludec and insulin aspart	Injection	203313	10,517,947	2037-12-14	DrugPatentWatch analysis and company disclosures
Novo Nordisk Inc.	RYZODEG 70/30	insulin degludec and insulin aspart	Injection	203313	10,751,402	2037-11-01	DrugPatentWatch analysis and company disclosures
Novo Nordisk Inc.	RYZODEG 70/30	insulin degludec and insulin aspart	Injection	203313	11,219,657	2037-12-21	DrugPatentWatch analysis and company disclosures
Novo Nordisk Inc.	RYZODEG 70/30	insulin degludec and insulin aspart	Injection	203313	11,623,010	2039-08-27	DrugPatentWatch analysis and company disclosures
Novo Nordisk Inc.	RYZODEG 70/30	insulin degludec and insulin aspart	Injection	203313	5,866,538	2017-06-20	DrugPatentWatch analysis and company disclosures
Novo Nordisk Inc.	RYZODEG 70/30	insulin degludec and insulin aspart	Injection	203313	6,899,699	2022-01-02	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for insulin degludec and insulin aspart 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.	RYZODEG 70/30	insulin degludec and insulin aspart	Injection	203313	11,110,151	2039-06-21	Patent claims search
Novo Nordisk Inc.	RYZODEG 70/30	insulin degludec and insulin aspart	Injection	203313	9,365,632	2033-10-09	Patent claims search
Novo Nordisk Inc.	RYZODEG 70/30	insulin degludec and insulin aspart	Injection	203313	9,474,688	2032-10-25	Patent claims search

International Patents for insulin degludec and insulin aspart

Country	Patent Number	Estimated Expiration
Argentina	071388
Argentina	072253
Argentina	072828
Australia	2009239429
Australia	2009246870
Australia	2009271129
Australia	2009274137

Supplementary Protection Certificates for insulin degludec and insulin aspart

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2013/034	Ireland		PRODUCT NAME: INSULIN DEGLUDEC; NAT REGISTRATION NO/DATE: EU/1/12/807-001, 004, 005, 007-009, 012, 013 015 20130121
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
471	Finland
35/2013	Austria		PRODUCT NAME: KOMBINATION VON INSULIN DEGLUDEC AND INSULIN ASPART UND BELIEBIGE ZN2+-KOMPLEXE DAVON; REGISTRATION NO/DATE: EU/1/12/806/001, EU/1/12/806/004, EU/1/12/806/005, EU/1/12/806/007, EU/1/12/806/008 (MITTEILUNG) 20180123
1390029-5	Sweden		PRODUCT NAME: INSULIN DEGLUDEK; REG. NO/DATE: EU/1/12/807/001 20130121
13C0035	France		PRODUCT NAME: INSULINE DEGLUDEC; REGISTRATION NO/DATE: EU/1/12/807/001 20130121
C201300036	Spain		PRODUCT NAME: INSULINA DEGLUDEC/INSULINA ASPART; NATIONAL AUTHORISATION NUMBER: EU/1/12/806/001, 004, 005, 007, 008; DATE OF AUTHORISATION: 20130121; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/12/806/001, 004, 005, 007, 008; DATE OF FIRST AUTHORISATION IN EEA: 20130121

Market Dynamics and Financial Trajectory for Insulin Degludec and Insulin Aspart

Last updated: February 14, 2026

Market Size and Growth

The global insulin market was valued at approximately $40 billion in 2022, with an annual growth rate (CAGR) of 8-10% projected through 2030. Growth drivers include rising diabetes prevalence, increased awareness, and innovations in insulin formulations.

Key Therapeutic Profiles

• Insulin Degludec (Tresiba): Ultra-long-acting basal insulin introduced in 2015 by Novo Nordisk. It provides 42 hours of glucose-lowering effect. Its steady profile reduces hypoglycemia risk.

• Insulin Aspart (Fiasp): Rapid-acting insulin, approved in 2017 by Novo Nordisk. It acts within 2.5 minutes post-injection with a duration of 5-8 hours. Designed for mealtime coverage.

Market Penetration and Competitive Landscape

• Insulin Degludec has gained market share due to its convenience and safety profile, especially in Type 1 and Type 2 diabetes trials. It accounts for roughly 15-20% of basal insulin sales globally.

• Insulin Aspart holds a dominant position within rapid-acting insulins, capturing approximately 25-30% of the rapid-acting insulin segment globally, competing with Novo Nordisk’s earlier insulin aspart and Lilly’s biosimilars.

Pricing and Reimbursement

• Both products are premium-priced compared to human insulins, with wholesale prices (US) reaching $250–$300 per unit. Payers negotiate prices, with discounts often exceeding 30%, particularly in Europe.

• Reimbursement varies widely; in the US, coverage is through Medicare Part D and private insurers. In Europe, membership in national healthcare systems influences pricing.

Regulatory and Patent Landscape

• Patent expirations are critical; insulin degludec's key patents expire around 2026-2028, opening opportunities for biosimilars.

• Biosimilar development is underway in several markets, but regulatory pathways in the US (FDA) and Europe (EMA) are complex, requiring demonstration of biosimilarity and interchangeability.

Pipeline and Future Trends

• Novo Nordisk and Sanofi are developing next-generation insulins with enhanced pharmacokinetics.

• Non-injective forms (e.g., inhaled insulin) threaten traditional subcutaneous formulations but face regulatory and safety hurdles.

• Digital health integration, such as insulin pens with dose tracking and connected devices, is improving adherence and outcomes, potentially impacting revenue streams.

Financial Trajectory Analysis

• Revenue for Tresiba reached around $2.7 billion in 2022, with an estimated CAGR of approximately 9% over five years.

• Fiasp revenue is approximately $600 million annually but is growing at a faster rate (~12%) as marketing expands.

• Biosimulation market entry could dilute prices and fragment margins, with biosimilars projected to capture 30-50% of biosimilar insulin sales within five years post-patent expiry.

Market Risks

• Patent cliffs on degludec and aspart could pressure prices and margins.

• Regulatory delays for biosimilars or novel formulations.

• Shifts toward alternative delivery systems or oral insulin development.

Key Takeaways

• The insulin market exhibits steady growth driven by diabetes prevalence and innovation.

• Central players like Novo Nordisk dominate, but biosimilar competition on the horizon could redefine pricing.

• Revenue growth for degludec and aspart remains stable, with price erosion anticipated upon patent expiry.

• Digital health and pipeline innovation influence long-term market potential.

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FAQs

What factors influence the pricing of insulin biologics?
Pricing is influenced by manufacturing costs, regulatory approval, patent protection, reimbursement policies, and market competition, especially from biosimilars.

How does biosimilar entry impact revenue?
Biosimilars tend to lower prices and increase market competition, threatening established brands' market share and margins.

What are the advantages of insulin degludec over other basal insulins?
Degludec offers a longer duration of action (up to 42 hours) and a more stable pharmacokinetic profile, reducing hypoglycemia risk.

What challenges do biosimilar insulins face in regulatory approval?
Demonstrating biosimilarity, ensuring interchangeability, and navigating complex regulatory requirements present significant hurdles.

What innovation trends could change the insulin market?
Digital health integration, new delivery devices, and oral insulin are potential disruptors augmenting existing therapies.

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Citations

[1] Allied Market Research, "Insulin Market by Product Type," 2022.
[2] Novo Nordisk Annual Report, 2022.
[3] FDA Regulatory Guidance, Biosimilar Insulins, 2021.
[4] IQVIA, Global Insulin Sales Data, 2022.
[5] European Medicines Agency, "Biosimilar Insulin Development," 2021.