RYZODEG 70/30 Drug Profile

Summary for Tradename: RYZODEG 70/30

High Confidence Patents:	21
Applicants:	1
BLAs:	1
Recent Clinical Trials:	See clinical trials for RYZODEG 70/30

Recent Clinical Trials for RYZODEG 70/30

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Sunshine Lake Pharma Co., Ltd.	Phase 3
Huashan Hospital	Phase 3
Second Affiliated Hospital, School of Medicine, Zhejiang University	N/A

See all RYZODEG 70/30 clinical trials

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 RYZODEG 70/30 Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for RYZODEG 70/30 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

3) Low Certainty: US Patents for RYZODEG 70/30 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 RYZODEG 70/30

Country	Patent Number	Estimated Expiration
France	13C0035
United Kingdom	2461186
Australia	2005298946
South Korea	100451778

Supplementary Protection Certificates for RYZODEG 70/30

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
300597	Netherlands		PRODUCT NAME: INSULINE DEGLUDEC EN INSULINE ASPART; REGISTRATION NO/DATE: EU/1/12/806/001 20130123
C201300035	Spain		PRODUCT NAME: INSULINA DEGLUDEC; NATIONAL AUTHORISATION NUMBER: EU/1/12/807/001, 004, 005, 007-009, 012, 013, 015; DATE OF AUTHORISATION: 20130121; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/12/807/001, 004, 005, 007-009, 012, 013, 015; DATE OF FIRST AUTHORISATION IN EEA: 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
C 2013 019	Romania		PRODUCT NAME: INSULINA DEGLUDECIN TOATE FORMELE SALE ASA CUM SUNT PROTEJATE IN BREVETUL DEBAZA; NATI: 20130121 ONAL AUTHORISATION NUMBER: EU/1/12/807/001; DATE OF NATIONAL AUTHORISATION: 20130121; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/12/807/001; DATE OF FIRST AUTHORISATION IN EEA

Market Dynamics and Financial Trajectory for RYZODEG 70/30

Last updated: September 23, 2025

Introduction

RYZODEG 70/30, a biosimilar combination insulin co-developed by Novo Nordisk, represents a significant advancement in diabetes management. This premixed biologic combines insulin degludec and insulin aspart, addressing the needs of patients requiring both basal and prandial insulin. As the landscape of insulin therapy evolves, understanding the market dynamics and financial outlook for RYZODEG 70/30 offers critical insights for stakeholders, including manufacturers, investors, and healthcare providers.

Market Context and Competitive Landscape

Diabetes, particularly type 2, remains a globally pervasive chronic condition, with the International Diabetes Federation estimating approximately 537 million adults affected worldwide as of 2021[1]. Insulin therapy remains central in managing advanced diabetes cases, with the global insulin market projected to expand at a CAGR of 8.8% through 2028[2].

The introduction of biosimilars like RYZODEG 70/30 is driven by the need to reduce healthcare costs and improve patient access. Biosimilars have gained momentum due to patent expirations of brand-name insulins such as Novo Nordisk’s Tresiba and Lilly’s Humalog. RYZODEG 70/30 positions itself uniquely as a combination product, competiting against both intrapartum basal insulins and premixed analogs like Novo Nordisk’s Novolog Mix 70/30.

Key competitors include:

• Tresiba (insulin degludec): Long-acting insulin with established market share.
• Fiasp (insulin aspart): Rapid-acting insulin.
• Novolog Mix 70/30: Premixed insulin analogs with a significant market foothold.
• Emerging biosimilars: Several biosimilar insulins are in development, which could impact market share.

Market Dynamics

Regulatory Environment

Regulatory pathways for biosimilars have become streamlined, especially within the European Union and the United States, facilitating quicker market access. The FDA approved the first biosimilar insulin in 2015, and multiple subsequent approvals have reduced overall barriers, lowering entry costs and increasing competition[3].

Pricing and Reimbursement

Pricing strategies for RYZODEG 70/30 are central to its market penetration. Biosimilars typically enter the market at 15-30% lower prices than innovator products[4]. Reimbursement policies in key markets such as the US, EU, and Japan heavily influence adoption rates. Countries prioritizing affordability and access tend to favor biosymilars, expanding the potential consumer base.

Physician and Patient Adoption

Physician confidence in prescribing biosimilars hinges on data demonstrating comparable efficacy and safety. Introduction of clinical evidence supporting RYZODEG’s biosimilarity can accelerate prescribing behaviors. Patient acceptance is similarly influenced by education, with adherence often improving when costs are lowered.

Market Penetration and Adoption Strategies

Manufacturers employ strategies like collaborative agreements with payers and healthcare providers, as well as patient education programs, to facilitate RYZODEG 70/30’s uptake. Additionally, formulary placements and inclusion in treatment guidelines significantly influence market share.

Financial Trajectory and Revenue Forecasts

Market Entry and Initial Revenue

Launch timing and geographic expansion critically shape revenue streams. RYZODEG 70/30 initially targets markets with high insulin utilization and strong biosimilar incentives, such as Europe and select Asian countries. Initial revenue projections are modest but expected to grow sharply as uptake accelerates.

Growth Drivers

• Cost Advantages: Biosimilar pricing reduces patient out-of-pocket expenses.
• Increasing Diabetes Prevalence: Growing global diabetes rates expand available patient populations.
• Product Differentiation: The pharmacokinetic profile of RYZODEG 70/30 offers convenience for patients and clinicians seeking simplified regimens.
• Regulatory Approvals: Approvals extending to more markets catalyze broader access.

Challenges Impacting Financial Performance

• Regulatory Delays: Any setbacks in approvals or manufacturing issues could defer revenue.
• Market Competition: New biosimilars or branded insulins could erode market share.
• Physician and Patient Acceptance: Hesitancy or lack of data confidence could slow adoption.
• Pricing Pressure: Payer negotiations may limit achievable margins.

Long-term Revenue Outlook

Analysts project that RYZODEG 70/30 could capture between 10-20% of the premixed insulin biosimilar market within 5 years of launch, translating to approximately $500 million to $1 billion in annual sales globally, contingent on successful market penetration and reimbursement landscape[5]. These estimates assume aggressive expansion in emerging markets and supportive policies in mature markets.

Market Growth Opportunities

• Emerging Markets: Countries with expanding healthcare coverage and high diabetes prevalence present lucrative opportunities.
• Combination Therapy Integration: RYZODEG 70/30 can serve as part of combination regimens, expanding its use cases.
• Innovative Formulations: Development of related delivery devices and formulations enhances patient adherence and market appeal.
• Digital Health Integration: Combining RYZODEG 70/30 with digital diabetes management tools can improve outcomes and drive market demand.

Risk Factors

• Regulatory Uncertainty: Delays or refusals could hinder market entry.
• Pricing and Reimbursement Constraints: Limited reimbursement could restrict access.
• Market Saturation: Dominance of established insulins and biosimilars could limit growth.
• Clinical Data Evolution: Emerging evidence impacting biosimilar confidence may influence adoption.

Conclusion

RYZODEG 70/30’s market dynamics are shaped by regulatory trends, pricing strategies, clinician and patient acceptance, and competitive pressures. Its financial trajectory hinges on successful market expansion, particularly in emerging markets, alongside effective positioning against existing insulins and biosimilars. Anticipated revenue growth reflects favorable diabetes epidemiology trends and strategic deployment, positioning RYZODEG 70/30 as a promising contributor in the biologic insulin segment.

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Key Takeaways

• RYZODEG 70/30 occupies a strategic position in the evolving biosimilar insulin market, with significant growth potential.
• Market success depends heavily on regulatory approvals, cost reductions, and stakeholder acceptance.
• Competitive pressures and payer policies will influence pricing and adoption rates.
• Long-term revenue prospects are positive, notably with expansion into emerging markets and integration into combination therapies.
• Strategic marketing and education are crucial for maximizing clinical and commercial success.

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FAQs

1. What distinguishes RYZODEG 70/30 from other premixed insulins?
RYZODEG 70/30 combines insulin degludec’s ultra-long action with insulin aspart’s rapid onset, offering a stable, flexible regimen that may reduce injection frequency and improve glucose control compared to traditional premixed insulins.

2. How does the biosimilar status of RYZODEG 70/30 impact its pricing and market access?
As a biosimilar, RYZODEG 70/30 generally enters markets at lower prices than originators, facilitating stronger reimbursement prospects and expanding patient access amid cost pressures.

3. Which markets are most promising for RYZODEG 70/30?
Europe and certain Asian countries, including Japan and South Korea, present immediate opportunities due to established biosimilar pathways and high diabetes prevalence. Emerging markets like India and Latin America are also attractive as healthcare infrastructure improves.

4. What are the main barriers to RYZODEG 70/30’s adoption?
Physician hesitancy due to limited clinical data compared to traditional insulins, reimbursement restrictions, and entrenched preferences for existing brand-name products pose initial barriers.

5. How does RYZODEG 70/30 fit into broader diabetes management strategies?
Its premixed, combined formulation simplifies treatment, potentially improving adherence and glycemic outcomes, making it suitable for patients requiring both basal and prandial insulin coverage.

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References

[1] International Diabetes Federation. "IDF Diabetes Atlas," 2021.
[2] MarketWatch. "Global Insulin Market Forecast," 2023.
[3] U.S. Food and Drug Administration. "Biosimilar Insulins," 2015.
[4] IQVIA. "Biosimilar Market Trends," 2022.
[5] EvaluatePharma. "Biologic and Biosimilar Insulin Outlook," 2023.