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. 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 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 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		2016-06-20	Company disclosures
Novo Nordisk Inc.	RYZODEG 70/30	insulin degludec and insulin aspart	Injection	203313		2021-01-05	Company disclosures
Novo Nordisk Inc.	RYZODEG 70/30	insulin degludec and insulin aspart	Injection	203313		2023-08-05	Company disclosures
Novo Nordisk Inc.	RYZODEG 70/30	insulin degludec and insulin aspart	Injection	203313		2024-10-21	Company disclosures
Novo Nordisk Inc.	RYZODEG 70/30	insulin degludec and insulin aspart	Injection	203313		2021-01-05	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		2028-08-11	Patent claims search
Novo Nordisk Inc.	RYZODEG 70/30	insulin degludec and insulin aspart	Injection	203313		2032-10-09	Patent claims search
Novo Nordisk Inc.	RYZODEG 70/30	insulin degludec and insulin aspart	Injection	203313		2031-10-25	Patent claims search

International Patents for insulin degludec and insulin aspart

Country	Patent Number	Estimated Expiration
Australia	2006207744
Denmark	2275439
Poland	1843809
Poland	1909870
Poland	189964

Supplementary Protection Certificates for insulin degludec and insulin aspart

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
31/2013	Austria		PRODUCT NAME: INSULIN DEGLUDEC UND BELIEBIGE ZN2+-KOMPLEXE DAVON; REGISTRATION NO/DATE: EU/1/12/807/001, EU/1/12/807/004, EU/1/12/807/005, EU/1/12/807/007, EU/1/12/807/008, EU/1/12/807/009, EU/1/12/807/012, EU/1/12/807/013, EU/1/12/807/015 (MITTEILUNG) 20130123
122013000062	Germany		PRODUCT NAME: KOMBINATION VON INSULIN DEGLUDEC UND INSULIN ASPART IN ALLEN DURCH DAS BASISPATENT GESCHUETZTEN FORMEN; REGISTRATION NO/DATE: EU/1/12/806/001 EU/1/12/806/004-005 EU/1/12/806/007-008 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
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
SPC/GB13/037	United Kingdom		PRODUCT NAME: INSULIN DEGLUDEC, OR PHARMACEUTICALLY ACCEPTABLE SOLVATES, HYDRATES, COMPLEXES, OR SALTS THEREOF; REGISTERED: UK EU/1/12/807/001 20130123; UK EU/1/12/807/004 20130123; UK EU/1/12/807/005 20130123; UK EU/1/12/807/007 20130123; UK EU/1/12/807/008 20130123; UK EU/1/12/807/009 20130123; UK EU/1/12/807/012 20130123; UK EU/1/12/807/013 20130123; UK EU/1/12/807/015 20130123

Market Dynamics and Financial Trajectory for Insulin Degludec and Insulin Aspart

Introduction

Insulin degludec and insulin aspart, particularly in their co-formulation known as IDegAsp, have been significant players in the diabetes management market. This article delves into the market dynamics, financial trajectory, and clinical implications of these insulin products.

Clinical Profile of Insulin Degludec and Insulin Aspart

Mechanism of Action

Insulin degludec is a long-acting basal insulin analog with a flat pharmacokinetic profile, providing a stable and long-lasting glucose-lowering effect. Insulin aspart is a rapid-acting insulin analog. The co-formulation, IDegAsp, combines 70% insulin degludec and 30% insulin aspart in a single injection, offering both prandial and basal glycemic coverage[5].

Clinical Benefits

IDegAsp has been shown to reduce the risk of hypoglycemia, a critical safety concern in diabetes management. Clinical trials and real-world studies have demonstrated that IDegAsp maintains glycemic control while minimizing the risk of nocturnal severe hypoglycemic episodes[5][2].

Pediatric Use

Studies have also explored the use of insulin degludec and IDegAsp in pediatric patients. These studies indicate that these insulins can achieve glycemic control with smaller total daily insulin doses, although they highlight the need for pediatric-specific dosing considerations to mitigate the risk of hypoglycemia[1].

Market Dynamics

Pricing Trends

The insulin market has seen significant pricing fluctuations. From 2012 to 2015, the net prices of long-acting insulin products, including insulin degludec (Tresiba), increased substantially. However, the introduction of biosimilar insulins like Basaglar (bioequivalent to Lantus) and the entry of new products led to a decrease in net prices from 2015 onwards[4].

Recent Price Adjustments

Novo Nordisk, the manufacturer of insulin degludec and IDegAsp, has recently announced significant price reductions for several of its insulin products. Effective January 1, 2024, the list prices of these insulins will be reduced by up to 75%, including a 65% reduction for Tresiba (insulin degludec) and similar reductions for other products like NovoLog (insulin aspart)[3].

Market Share and Competition

The introduction of biosimilars and new insulin products has altered the market share dynamics. For instance, the entry of Admelog (insulin lispro) and Fiasp (fast-acting insulin aspart) has influenced the market share of incumbent insulins. However, IDegAsp remains a competitive option due to its unique co-formulation and clinical benefits[4].

Financial Trajectory

Budget Impact Analysis

A budget impact analysis conducted in the Saudi healthcare system revealed that switching from BIAsp30 to IDegAsp could result in significant cost savings over a five-year period. The analysis estimated a reduction in total cumulative costs, primarily driven by the decrease in hypoglycemia events and associated management costs. This translates to cost savings of around $13 million over five years[2].

Cost Components

The financial trajectory of IDegAsp is influenced by several cost components:

• Insulin Acquisition Costs: While the acquisition cost of IDegAsp is higher than some other insulins, the overall cost is offset by the reduction in hypoglycemia-related costs.
• Hypoglycemia Management: The lower risk of hypoglycemia with IDegAsp reduces the costs associated with managing and monitoring hypoglycemic events.
• Healthcare System Savings: The overall impact on the healthcare system includes savings from reduced hospitalizations, emergency visits, and other healthcare resources related to hypoglycemia management[2].

Economic Evidence and Decision-Making

Clinical and Economic Considerations

The decision to prescribe IDegAsp or other insulins is based on both clinical and economic evidence. Guidelines recommend comparing new insulins with standard insulins rather than placebos or non-insulin agents. This approach helps in assessing the long-term clinical and economic consequences of using these insulins[2].

Sensitivity Analysis

Deterministic sensitivity analysis (DSA) has shown that the budget impact model is highly sensitive to parameters such as acquisition cost, average daily dose, and the incidence of non-severe hypoglycemia. These analyses help in understanding the robustness of the cost savings associated with IDegAsp[2].

Patient and Healthcare System Impact

Quality of Life

The use of IDegAsp can significantly improve the quality of life for patients with diabetes by reducing the risk of hypoglycemia and simplifying insulin regimens. This co-formulation eliminates the need for multiple injections and reduces the complexity of insulin management[5].

Healthcare Resource Utilization

By reducing hypoglycemia events, IDegAsp can lower the utilization of healthcare resources such as emergency services, hospitalizations, and outpatient visits. This not only saves costs but also enhances patient safety and outcomes[2].

Conclusion

Insulin degludec and insulin aspart, particularly in the co-formulation IDegAsp, offer significant clinical and economic benefits in the management of diabetes. The recent price reductions by Novo Nordisk are expected to make these insulins more accessible, further enhancing their market dynamics. The financial trajectory of IDegAsp is characterized by cost savings driven by reduced hypoglycemia events and associated management costs, making it a valuable option for both patients and healthcare systems.

Key Takeaways

• Clinical Benefits: IDegAsp reduces the risk of hypoglycemia and maintains glycemic control with a simpler insulin regimen.
• Pricing Trends: Recent price reductions by Novo Nordisk make IDegAsp more affordable.
• Cost Savings: Switching to IDegAsp can result in significant cost savings due to reduced hypoglycemia events.
• Market Dynamics: The introduction of biosimilars and new products influences market share, but IDegAsp remains competitive.
• Patient Impact: IDegAsp improves quality of life by simplifying insulin management and reducing hypoglycemia risk.

FAQs

Q: What is the co-formulation of insulin degludec and insulin aspart?

A: The co-formulation, known as IDegAsp, combines 70% insulin degludec and 30% insulin aspart in a single injection.

Q: How does IDegAsp impact hypoglycemia risk?

A: IDegAsp reduces the risk of hypoglycemia compared to other insulin regimens, which is a significant clinical benefit.

Q: What are the recent price adjustments for insulin degludec and insulin aspart?

A: Novo Nordisk has reduced the list prices of these insulins by up to 75%, effective January 1, 2024.

Q: How does IDegAsp affect healthcare costs?

A: IDegAsp can result in cost savings by reducing the incidence of hypoglycemia and associated management costs.

Q: Is IDegAsp suitable for pediatric patients?

A: Yes, but pediatric-specific dosing considerations are necessary to mitigate the risk of hypoglycemia.

Sources

1. FDA: Insulin Degludec Insulin Aspart Clinical Prea (2) - FDA
2. ISPOR: Budget Impact Analysis of IDegAsp for the Management of ... - ISPOR
3. Managed Healthcare Executive: Novo Nordisk Cuts Price on Several Insulin Products by 75%
4. JAMA Health Forum: Estimated Changes in Insulin Prices and Discounts After Entry of ...
5. Frontiers in Clinical Diabetes and Healthcare: Intensification of Insulin Treatment With Insulin Degludec/Aspart in ...