Insulin degludec - Biologic Drug Details

Summary for insulin degludec

Tradenames:	1
High Confidence Patents:	9
Applicants:	1
BLAs:	3
Suppliers: see list	3
Recent Clinical Trials:	See clinical trials for insulin degludec
Drug Prices:	Drug price information for insulin degludec
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for insulin degludec

Recent Clinical Trials for insulin degludec

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Ministry of Health, Saudi Arabia	Phase 1/Phase 2
Ain Shams University	N/A
Gan and Lee Pharmaceuticals, USA	Phase 2

See all insulin degludec clinical trials

Recent Litigation for insulin degludec

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 insulin degludec litigation

Pharmacology for insulin degludec

Established Pharmacologic Class	Insulin Analog
Chemical Structure	Insulin

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 Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for insulin degludec 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.	TRESIBA	insulin degludec	Injection	203314	10,220,155	2026-07-17	Company disclosures
Novo Nordisk Inc.	TRESIBA	insulin degludec	Injection	203314	10,357,616	2037-11-17	Company disclosures
Novo Nordisk Inc.	TRESIBA	insulin degludec	Injection	203314	10,376,652	2037-02-24	Company disclosures
Novo Nordisk Inc.	TRESIBA	insulin degludec	Injection	203314	11,097,063	2039-01-17	Company disclosures

3) Low Certainty: US Patents for insulin degludec 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.	TRESIBA	insulin degludec	Injection	203314	10,137,172	2033-04-30	Patent claims search
Novo Nordisk Inc.	TRESIBA	insulin degludec	Injection	203314	10,335,464	2040-04-01	Patent claims search
Novo Nordisk Inc.	TRESIBA	insulin degludec	Injection	203314	10,369,114	2033-03-14	Patent claims search
Novo Nordisk Inc.	TRESIBA	insulin degludec	Injection	203314	10,493,125	2035-12-09	Patent claims search

International Patents for insulin degludec

Country	Patent Number	Estimated Expiration
Denmark	1819382
Russian Federation	2401133
South Korea	20120026629
World Intellectual Property Organization (WIPO)	2007017052

Supplementary Protection Certificates for insulin degludec

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
13C0035	France		PRODUCT NAME: INSULINE DEGLUDEC; REGISTRATION NO/DATE: EU/1/12/807/001 20130121
122013000061	Germany		PRODUCT NAME: INSULIN DEGLUDEC IN ALLEN DURCH DAS BASISPATENT GESCHUETZTEN FORMEN; REGISTRATION NO/DATE: EU/1/12/807/001 EU/1/12/807/004-005 EU/1/12/807/007-009 EU/1/12/807/012-013 EU/1/12/807/015 20130121
2013/34	Ireland		PRODUCT: INSULIN DEGLUDEC IN ALL ITS FORMS AS THEY ARE PROTECTED BY THE BASIC PATENTS; REGISTRATION NO/DATE: IRELAND EU/1/12/807-001, 004, 005, 007-009, 012, 013 AND 015 / 21/01/2013
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

Market Dynamics and Financial Trajectory for Insulin Degludec

Introduction

Insulin degludec, marketed under the brand name Tresiba, is a long-acting basal insulin analog developed by Novo Nordisk. It has been gaining significant attention in the diabetes treatment market due to its unique pharmacological profile and cost-effectiveness. Here, we delve into the market dynamics and financial trajectory of insulin degludec.

Market Growth and Demand

The global long-acting insulin market, which includes insulin degludec, is projected to grow at a CAGR of 9.4% from 2021 to 2031, driven primarily by the rising prevalence of diabetes, an increasing geriatric population, and advancements in research and development[4].

Cost-Effectiveness

Insulin degludec has been consistently shown to be a cost-effective option in various studies. A health economic analysis based on the SWITCH 1 and 2 trials demonstrated that insulin degludec is less expensive and more effective than insulin glargine U100, particularly in reducing the risk of hypoglycemic episodes. For patients with type 1 diabetes, this translated into an annual cost saving of £12.83 per patient, along with a quality-adjusted life year (QALY) gain of 0.0208[2].

In Italy, a long-term economic model showed that switching to insulin degludec from other basal insulins resulted in significant cost savings and improved health outcomes. The total incremental cost for degludec was €-6,310 and €-2,682 for patients with type 1 and type 2 diabetes, respectively, indicating that degludec was dominant in terms of both cost and health benefits[1].

Comparative Cost Analysis

A study in the UK comparing insulin degludec with insulin detemir (IDet) in children and adolescents with type 1 diabetes found substantial cost savings in favor of degludec. The mean annual cost per patient was £235.16 for degludec versus £382.91 for IDet, resulting in an annual saving of £147.75 per patient. These savings were attributed to reductions in hyperglycemia with ketosis and basal insulin dose[5].

Reduction in Hypoglycemia Costs

One of the key drivers of the cost-effectiveness of insulin degludec is its ability to reduce recurrent and costly episodes of hypoglycemia. Studies have shown that the reduction in hypoglycemic events significantly lowers the overall cost of diabetes management, including costs associated with staff management, glucose strip testing, and treatment of hypoglycemic episodes[2].

Market Competition

The insulin market is currently dominated by a few major players, with Novo Nordisk being one of the key players. However, the regulatory landscape is evolving, with the FDA aiming to increase competition by facilitating the development of biosimilar insulins. This could potentially impact the pricing and market dynamics of branded insulins like degludec in the future[3].

Regional Market Dynamics

The market dynamics for insulin degludec vary by region. In Europe, for example, the drug has been shown to be cost-effective in several countries, including Italy and the UK. In the US, the high cost of analog insulins, including degludec, remains a significant issue, with efforts underway to increase competition and reduce prices[1][2][3].

Distribution Channels

Insulin degludec is distributed through various channels, including hospital pharmacies, retail pharmacies, and mail-order pharmacies. The ease of access through these channels contributes to its market penetration and patient adherence[4].

Future Outlook

Given the growing prevalence of diabetes and the increasing need for cost-effective treatments, insulin degludec is poised for continued growth. The long-acting insulin market, driven by products like degludec, is expected to expand significantly over the next decade. However, the introduction of biosimilar insulins and changes in regulatory policies could influence the market trajectory and pricing strategies for branded insulins[4].

Key Takeaways

• Insulin degludec is a cost-effective long-acting basal insulin analog.
• It reduces the risk of hypoglycemic episodes, leading to significant cost savings.
• Studies in various regions, including Italy and the UK, have demonstrated its dominance over other basal insulins in terms of cost and health benefits.
• The global long-acting insulin market is expected to grow at a CAGR of 9.4% from 2021 to 2031.
• Market competition is expected to increase with the introduction of biosimilar insulins.

FAQs

What is insulin degludec, and how does it differ from other basal insulins?

Insulin degludec is a long-acting basal insulin analog with a unique pharmacological profile that provides a flat and stable glucose-lowering effect over 42 hours. It differs from other basal insulins like insulin glargine U100 and insulin detemir in its duration of action and reduced risk of hypoglycemic episodes.

How cost-effective is insulin degludec compared to other basal insulins?

Insulin degludec has been shown to be cost-effective in several studies. It reduces the frequency of hypoglycemic episodes and associated costs, leading to annual savings compared to other basal insulins like insulin glargine U100 and insulin detemir.

What are the key drivers of the cost-effectiveness of insulin degludec?

The key drivers include the reduction in recurrent and costly episodes of hypoglycemia, lower basal insulin doses, and the associated reduction in costs related to staff management, glucose strip testing, and treatment of hypoglycemic episodes.

How does the market competition affect the pricing of insulin degludec?

The insulin market is currently dominated by a few major players, but the introduction of biosimilar insulins is expected to increase competition and potentially reduce prices. Regulatory changes aimed at facilitating the development of biosimilar insulins could impact the pricing and market dynamics of branded insulins like degludec.

What is the future outlook for the long-acting insulin market, including insulin degludec?

The long-acting insulin market is expected to grow significantly over the next decade, driven by the rising prevalence of diabetes and the need for cost-effective treatments. However, the introduction of biosimilar insulins and changes in regulatory policies could influence the market trajectory and pricing strategies.

How is insulin degludec distributed, and what are the common distribution channels?

Insulin degludec is distributed through various channels, including hospital pharmacies, retail pharmacies, and mail-order pharmacies, ensuring ease of access and contributing to its market penetration and patient adherence.

Sources:

1. Cost-effectiveness of switching to insulin degludec from other basal insulin in Italian patients with type 1 or type 2 diabetes. PubMed.
2. New economic data finds Novo Nordisk's insulin degludec most cost effective diabetic treatment. European Pharmaceutical Review.
3. Transcript Insulin Biosimilars Part 15. FDA.
4. Long-Acting Insulin Market Size, Share & Trends Report. Fact.MR.
5. Cost analysis of insulin degludec in comparison with insulin detemir in children and adolescents with type 1 diabetes in the UK. PubMed.