RYZODEG 70/30 Drug Profile

Summary for Tradename: RYZODEG 70/30

High Confidence Patents:	9
Applicants:	1
BLAs:	1
Recent Clinical Trials:	See clinical trials for RYZODEG 70/30
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases 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

Recent Litigation for RYZODEG 70/30

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
NOVO NORDISK INC. v. RIO BIOPHARMACEUTICALS, INC.	2024-02-05
Novo Nordisk, Inc. v. Mylan Pharmaceuticals, Inc.	2022-08-08
In Re: Ozempic (Semaglutide) Patent Litigation	2022-08-05

See all RYZODEG 70/30 litigation

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. General 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 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 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	5,866,538	2016-06-20	Company disclosures
Novo Nordisk Inc.	RYZODEG 70/30	insulin degludec and insulin aspart	Injection	203313	6,899,699	2021-01-05	Company disclosures
Novo Nordisk Inc.	RYZODEG 70/30	insulin degludec and insulin aspart	Injection	203313	7,615,532	2023-08-05	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		Patent claims search
Novo Nordisk Inc.	RYZODEG 70/30	insulin degludec and insulin aspart	Injection	203313	9,365,632	2032-10-09	Patent claims search
Novo Nordisk Inc.	RYZODEG 70/30	insulin degludec and insulin aspart	Injection	203313	9,474,688	2031-10-25	Patent claims search

International Patents for RYZODEG 70/30

Country	Patent Number	Estimated Expiration
China	101107031
World Intellectual Property Organization (WIPO)	2005012347
China	101084028

Supplementary Protection Certificates for RYZODEG 70/30

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C20130014 00133	Estonia		PRODUCT NAME: DEGLUDEKINSULIIN/ASPARTINSULIIN;REG NO/DATE: K(2013)368 (LOPLIK) 23.01.2013
92226	Luxembourg		PRODUCT NAME: COMBINATION D'INSULINE DEGLUDEC ET INSULINE ASPARTE SOUS TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE; AUTHORISATION NUMBER AND DATE: EU/1/12/806/001,004,005,007,008 - RYZODEG 20130123
CA 2013 00033	Denmark

RYZODEG 70/30 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for RYZODEG 70/30

Introduction

RYZODEG 70/30, a combination of insulin degludec (ultra-long acting basal insulin) and insulin aspart (rapid acting mealtime insulin), is a significant player in the diabetes management market. This article delves into the market dynamics and financial trajectory of RYZODEG 70/30, providing insights into its current status, future projections, and the competitive landscape.

Mechanism of Action and Clinical Use

RYZODEG 70/30 works by binding specifically to the human insulin receptor, mimicking the pharmacological effects of human insulin. This binding facilitates the uptake of glucose by muscle and fat cells and inhibits glucose output from the liver, thereby lowering blood glucose levels[3].

Market Assessment

The market for RYZODEG 70/30 is assessed across six major markets: Germany, France, Italy, Spain, the United Kingdom, and Japan. Here are some key points:

• Market Size and Forecast: The market size for RYZODEG 70/30 in these regions is projected to grow from 2019 to 2032. Detailed forecasts are provided in the report, showing the market size in each country and the overall 6MM (six major markets) in USD million[1].
• Competitive Landscape: The market is competitive, with both marketed and emerging therapies. RYZODEG 70/30 faces competition from other insulin analogs and novel approaches to diabetes treatment. The launch of late-stage emerging therapies is expected to significantly impact the market[1].

Dosage and Administration

The recommended starting dose of RYZODEG 70/30 for adults with type 1 diabetes is 60-70% of the total daily insulin requirements, administered once daily at mealtime in combination with short-/rapid-acting insulin at the remaining meals. For type 2 diabetes, the starting dose is typically 10 units with meals, followed by individual dosage adjustments[3].

Regulatory and Developmental Activities

RYZODEG 70/30 has undergone various regulatory milestones and developmental activities. The drug has been approved for use in several countries, and ongoing research aims to optimize its use and expand its indications. Regulatory approvals and clinical trials are crucial for its market positioning[1].

Financial Performance

Revenue and Sales Growth

Novo Nordisk, the manufacturer of RYZODEG 70/30, has reported significant sales growth. While the specific financial data for RYZODEG 70/30 is not isolated in the broader financial reports, the overall diabetes care segment has seen substantial growth. For instance, Novo Nordisk's sales in the first nine months of 2024 showed a 24% growth at constant exchange rates, driven partly by their diabetes portfolio[2].

Operating Profit and Margins

The operating profit and margins for Novo Nordisk have been impacted by various factors, including research and development costs and operational leverage. The company's operating profit grew by 22% at constant exchange rates, reflecting the strong sales performance of their diabetes products[2].

Competitive Landscape

The diabetes market is highly competitive, with several marketed and emerging therapies. RYZODEG 70/30 competes with other insulin analogs and combination products. The competitive landscape includes:

• Marketed Therapies: Other insulin products and combination therapies that are currently available in the market.
• Emerging Therapies: New treatments in late-stage development that could challenge RYZODEG 70/30's market position[1].

Future Market Projections

The market for RYZODEG 70/30 is expected to grow due to several factors:

• Increasing Prevalence of Diabetes: The global prevalence of diabetes is rising, driving the demand for effective insulin therapies.
• Healthcare Spending: Incremental healthcare spending across the world is expected to expand the market size for diabetes treatments.
• Research and Development: Ongoing research and development in diabetes care are likely to introduce new therapies and improve existing ones, including RYZODEG 70/30[1].

Challenges and Opportunities

Challenges

• Market Competition: The launch of new and emerging therapies poses a significant challenge to RYZODEG 70/30's market dominance.
• Regulatory Environment: Changes in regulatory frameworks and approval processes can affect the drug's market access and sales.
• Patient Safety and Efficacy: Ensuring patient safety and efficacy remains a critical challenge, particularly in pediatric patients where there is a higher risk of severe hypoglycemia[3].

Opportunities

• Expanding Indications: Potential expansion of indications for RYZODEG 70/30 could increase its market share.
• Global Health Initiatives: Increased focus on global health initiatives and diabetes management programs can drive demand for effective insulin therapies.
• Technological Advancements: Improvements in insulin delivery systems and monitoring technologies can enhance the use and efficacy of RYZODEG 70/30[1].

Regional Insights

The market for RYZODEG 70/30 varies by region:

• EU4 and the UK: These markets are well-established and have a high demand for diabetes treatments.
• Japan: This market also shows significant potential due to its aging population and high prevalence of diabetes.
• Global Trends: The global biological drugs market, which includes insulin analogs, is expected to grow, driven by factors such as demographic trends and advancements in healthcare infrastructure[4].

Key Takeaways

• RYZODEG 70/30 is a combination insulin product with a strong market presence in the diabetes care segment.
• The market for RYZODEG 70/30 is projected to grow from 2019 to 2032, driven by increasing healthcare spending and the rising prevalence of diabetes.
• The competitive landscape is dynamic, with both marketed and emerging therapies posing challenges and opportunities.
• Regulatory and developmental activities are crucial for the drug's continued success.
• Novo Nordisk's financial performance indicates strong sales growth in the diabetes segment, which benefits RYZODEG 70/30.

FAQs

What is RYZODEG 70/30?

RYZODEG 70/30 is a combination insulin product consisting of insulin degludec (ultra-long acting basal insulin) and insulin aspart (rapid acting mealtime insulin), used to improve glycemic control in adults with diabetes mellitus.

How is RYZODEG 70/30 administered?

RYZODEG 70/30 is administered subcutaneously, once or twice daily with the main meal(s), and should not be administered intravenously or intramuscularly.

What are the key markets for RYZODEG 70/30?

The key markets include Germany, France, Italy, Spain, the United Kingdom, and Japan.

What are the challenges faced by RYZODEG 70/30 in the market?

RYZODEG 70/30 faces challenges from market competition, regulatory changes, and ensuring patient safety and efficacy, particularly in pediatric patients.

What are the future projections for the market size of RYZODEG 70/30?

The market size for RYZODEG 70/30 is projected to grow from 2019 to 2032, driven by increasing healthcare spending and the rising prevalence of diabetes.

Sources

1. RYZODEG Drug Insight and Market Forecast - 2032 - ResearchAndMarkets
2. Novo Nordisk Investor Presentation Q3 2024 - Novo Nordisk
3. RYZODEG 70/30 Data Sheet - Novo Nordisk New Zealand
4. Biological Drugs Market: Global Industry Analysis - Maximize Market Research