Insulin aspart protamine and insulin aspart - Biologic Drug Details

Summary for insulin aspart protamine and insulin aspart

Tradenames:	2
High Confidence Patents:	13
Applicants:	1
BLAs:	2
Suppliers: see list	4

Pharmacology for insulin aspart protamine and insulin aspart

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 aspart protamine and insulin aspart Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for insulin aspart protamine 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.	NOVOLOG MIX 70/30	insulin aspart protamine and insulin aspart	Injectable Suspension	021172		2013-08-20	Company disclosures
Novo Nordisk Inc.	NOVOLOG MIX 70/30	insulin aspart protamine and insulin aspart	Injectable Suspension	021172		2014-04-08	Company disclosures
Novo Nordisk Inc.	NOVOLOG MIX 70/30	insulin aspart protamine and insulin aspart	Injectable Suspension	021172		2014-12-02	Company disclosures
Novo Nordisk Inc.	NOVOLOG MIX 70/30	insulin aspart protamine and insulin aspart	Injectable Suspension	021172		2013-06-21	Company disclosures

3) Low Certainty: US Patents for insulin aspart protamine 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

International Patents for insulin aspart protamine and insulin aspart

Country	Patent Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	9748414
Russian Federation	2091088
China	1183975
Japan	2837956

Supplementary Protection Certificates for insulin aspart protamine and insulin aspart

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
10199011	Germany		PRODUCT NAME: KRISTALLE, ENTHALTEND ASP B28 HUMAN-INSULIN UND PROTAMIN; REGISTRATION NO/DATE: EU/1/00/142/001-008 20000801
41/2005	Austria		PRODUCT NAME: NOVOMIX 70 - SUSPENSION, ENTHALTEND LOESLICHES INSULIN ASPART UND PROTAMINKRISTALLISIERTES INSULIN ASPART IM VERHAELTNIS 70:30; REGISTRATION NO/DATE: EU/1/00/142/017 - EU/1/00/142/022 20051005
CA 2005 00046	Denmark		PRODUCT NAME: OPLOSELIGT INSULIN ASPART / PROTAMINKRYSTALLERET INSULIN ASPART 100E/ML I FORHOLDET 50/50
C00214826/01	Switzerland		FORMER REPRESENTATIVE: E. BLUM AND CO. PATENTANWAELTE, CH

Insulin aspart protamine and insulin aspart Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Insulin Aspart Protamine and Insulin Aspart

Introduction

Insulin aspart protamine and insulin aspart, commonly known by the brand name NovoLog Mix 70/30, are crucial biologic drugs used in the management of type 1 and type 2 diabetes. The market for these insulins is dynamic, influenced by various factors including regulatory changes, competitive pricing, and advancements in biosimilar technology.

Market Size and Growth

The global insulin market, which includes insulin aspart and its formulations, is substantial and growing. As of 2024, the human insulin drugs market is estimated to be around USD 27.96 billion and is projected to reach USD 33.81 billion by 2029, growing at a CAGR of 3.87% during this period[4].

Key Players and Market Concentration

The insulin market is highly concentrated, with a few major players dominating the landscape. Novo Nordisk, Eli Lilly, and Sanofi are among the key companies operating in this market. These companies have significant influence over pricing and market dynamics due to their extensive product portfolios and strong market presence[4].

Pricing and Affordability

Pricing has been a critical issue in the insulin market, with many patients facing high out-of-pocket costs. Recently, there has been a significant shift towards more affordable pricing. Novo Nordisk announced plans to cut the prices of its insulin products, including NovoLog Mix 70/30, by up to 75% starting in January 2024. This move follows similar price reductions by Eli Lilly, which slashed its insulin prices by 70% and implemented a $35 monthly out-of-pocket cost cap[1].

Impact of Price Reductions

The price cuts by major manufacturers are expected to significantly impact the market. For instance, Novo Nordisk's insulin aspart injection, which currently has a list price of approximately $600 for a 5-pack of injection pens, will be reduced to $139.71. This reduction will make insulin more affordable for millions of patients, particularly in the United States where over 8 million individuals rely on insulin[1].

Biosimilar Competition

The introduction of biosimilars is another key factor influencing the market dynamics of insulin aspart and its formulations. Biosimilars, such as those approved by the FDA for long-acting insulins, are expected to increase competition and drive down prices. For example, the approval of biosimilar long-acting insulins like Rezvolgar by Eli Lilly is expected to reduce costs and enhance patient affordability[4].

Cost-Effectiveness of Biosimilars

Studies have shown that biosimilars can be cost-effective alternatives to branded insulins. For instance, treatment with biosimilar recombinant human insulin and insulin NPH could cost less than $72 per patient per year, and biosimilars of insulin analogues like insulin aspart could be manufactured for prices of $133 per patient per year or less[3].

Regulatory Environment

The regulatory environment plays a crucial role in shaping the market for insulin aspart and its formulations. Recent FDA approvals for unbranded biologic insulins, such as Novo Nordisk's Degludec, and biosimilars like Rezvolgar, indicate a supportive regulatory framework that encourages competition and innovation[4].

Patient Compliance and Treatment Adherence

Long-acting and premixed insulins like NovoLog Mix 70/30 are designed to improve patient compliance. These insulins offer a consistent baseline insulin level over an extended period, reducing the frequency of injections and making it easier for patients to adhere to their treatment regimens. This aspect is expected to drive segmental growth as more patients opt for these convenient and effective treatment options[4].

Regional Market Dynamics

The insulin market varies significantly by region. North America holds the largest share of the market due to the high prevalence of diabetes and the presence of major pharmaceutical companies. The Asia Pacific region, however, is expected to be the fastest-growing market, driven by an increasing diabetic population and growing government initiatives to manage diabetes[4].

Financial Trajectory

The financial trajectory for insulin aspart and its formulations is influenced by several factors, including pricing strategies, biosimilar competition, and regulatory changes.

Revenue Impact

The recent price cuts announced by Novo Nordisk and Eli Lilly are expected to impact the revenue of these companies in the short term. However, these moves are also likely to increase patient access and potentially expand the market size by making insulin more affordable for a larger population[1].

Cost-Effectiveness and Long-Term Savings

Studies have shown that switching to more cost-effective insulins, such as biosimilars, can lead to significant long-term savings. For example, a cost-effectiveness analysis of biphasic insulin aspart (BIAsp 30) indicated that while it may increase lifetime direct medical costs, it also improves life expectancy and quality-adjusted life expectancy, making it a cost-effective option in the long run[2].

Conclusion

The market for insulin aspart protamine and insulin aspart is undergoing significant changes driven by pricing strategies, biosimilar competition, and regulatory approvals. The recent price reductions by major manufacturers are expected to make insulin more affordable, increasing patient access and potentially expanding the market. The introduction of biosimilars will continue to play a crucial role in driving down costs and enhancing competition.

Key Takeaways

• Pricing Reductions: Major manufacturers like Novo Nordisk and Eli Lilly have announced significant price cuts for their insulin products.
• Biosimilar Competition: The introduction of biosimilars is expected to increase competition and reduce costs.
• Regulatory Environment: FDA approvals for unbranded biologic insulins and biosimilars support a competitive market.
• Patient Compliance: Long-acting and premixed insulins improve patient compliance and treatment adherence.
• Regional Dynamics: North America holds the largest market share, while the Asia Pacific region is expected to be the fastest-growing.

FAQs

What are the recent price reductions announced by Novo Nordisk for its insulin products?

Novo Nordisk announced plans to cut the prices of its insulin products, including NovoLog Mix 70/30, by up to 75% starting in January 2024[1].

How do biosimilars impact the cost of insulin aspart and its formulations?

Biosimilars can be manufactured at significantly lower costs, with estimated prices ranging from $48 to $133 per patient per year, depending on the type of insulin analogue[3].

What is the current market size of the human insulin drugs market?

The human insulin drugs market is estimated to be around USD 27.96 billion in 2024[4].

Which region is expected to be the fastest-growing market for insulin?

The Asia Pacific region is expected to be the fastest-growing market for insulin during the forecast period (2024-2029)[4].

How do long-acting insulins like NovoLog Mix 70/30 improve patient compliance?

Long-acting insulins like NovoLog Mix 70/30 offer a consistent baseline insulin level over an extended period, reducing the frequency of injections and making it easier for patients to adhere to their treatment regimens[4].

Sources

1. Novo Nordisk To Cut Insulin Prices Up To 75% - Drug Topics
2. Cost-effectiveness of switching to biphasic insulin aspart - PubMed
3. Production costs and potential prices for biosimilars of human insulin - BMJ Global Health
4. Insulin Market - Size, Share, Growth & Trends - Mordor Intelligence
5. Insulin Therapy Components - American Academy of Family Physicians