NOVOLOG MIX 70 Drug Profile

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 NOVOLOG MIX 70 Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for NOVOLOG MIX 70 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
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 NOVOLOG MIX 70 Derived from Patent Text Search

No patents found based on company disclosures

International Patents for NOVOLOG MIX 70

Country	Patent Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	9748414
Russian Federation	2091088
Czech Republic	2002927
Japan	4490496
Germany	60043595

Supplementary Protection Certificates for NOVOLOG MIX 70

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
40/2005	Austria		PRODUCT NAME: NOVOMIX 50 - SUSPENSION, ENTHALTEND LOESLICHES INSULIN ASPART UND PROTAMINKRISTALLISIERTES INSULIN ASPART IM VERHAELTNIS 50:50; REGISTRATION NO/DATE: EU/1/00/142/011 - EU/1/00/142/016 20051005

NOVOLOG MIX 70 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for NovoLog Mix 70/30

Introduction to NovoLog Mix 70/30

NovoLog Mix 70/30, a pre-mix insulin developed by Novo Nordisk, is a crucial medication for individuals living with diabetes. This insulin combines 70% insulin aspart protamine and 30% insulin aspart, providing both basal and bolus insulin coverage. Here, we will delve into the market dynamics and financial trajectory of NovoLog Mix 70/30, especially in light of recent significant price reductions.

Market Context and Competitors

The insulin market is highly competitive, with major players including Novo Nordisk, Eli Lilly, and Sanofi. Recently, there has been a shift in market dynamics due to increasing pressure to reduce insulin prices. In March 2023, Novo Nordisk announced a 75% price cut for several of its insulin products, including NovoLog Mix 70/30, effective January 1, 2024. This move follows similar actions by Eli Lilly, which reduced its insulin prices by 70% and expanded its Insulin Value Program[4].

Price Reductions and Impact

New Pricing Structure

As of January 1, 2024, the list price of NovoLog Mix 70/30 will be significantly reduced. The new prices will be $72.34 for a vial and $139.71 for the FlexPen, representing a 75% reduction from the current list prices[4].

Patient Affordability

This price cut is aimed at reducing the financial burden on patients living with diabetes. Novo Nordisk has emphasized its commitment to patient affordability, recognizing the difficulties many patients face in paying for healthcare, including insulin[1][3][4].

Market Dynamics

The price reduction is part of a broader strategy to transform the complex pricing system and foster better pricing predictability. This move is also influenced by evolving policy changes and stakeholder interests. By reducing prices, Novo Nordisk aims to balance patient affordability with market dynamics and policy shifts[1][3].

Financial Trajectory

Revenue Impact

While the price reduction will likely decrease the revenue generated from NovoLog Mix 70/30 in the short term, Novo Nordisk's overall financial performance is expected to remain robust. The company has seen strong growth in recent years, driven by demand for its market-leading GLP-1 therapies and other products[5].

Sales and Market Share

Despite the price cuts, Novo Nordisk's market share is expected to remain strong due to its extensive product portfolio and continued innovation. The company has been investing heavily in research and development, including pipeline projects such as once-weekly insulin icodec and the novel combination drug candidate CagriSema[5].

Financial Performance

In the fiscal year 2023, Novo Nordisk reported significant financial growth, with net sales increasing by 31% to DKK 232.3 billion. The operating profit also saw a substantial increase of 37% to DKK 102.6 billion. These figures indicate the company's financial stability and capacity to absorb the impact of price reductions while continuing to invest in research and development[2].

Strategic Aspirations and Future Outlook

Innovation and Pipeline

Novo Nordisk is committed to innovation, with several pipeline projects that could significantly impact the diabetes and obesity treatment landscapes. The development of insulin icodec, potentially the world’s first once-weekly basal insulin, and the novel combination therapy CagriSema, are examples of the company's forward-looking strategy[2].

Sustainability and Social Responsibility

The company is also focused on sustainability and social responsibility. Novo Nordisk has reduced its CO2 equivalent emissions by 34% since 2019 and is supporting its suppliers in transitioning to 100% renewable power. These initiatives align with the company's long-term perspective and commitment to creating a sustainable business model[2].

Access and Affordability Initiatives

Patient Support Programs

Novo Nordisk has been actively involved in various access and affordability initiatives. The company has reached over 6.7 million vulnerable patients with its insulin medicines and aims to continue reducing the burden of out-of-pocket costs for patients living with diabetes[2].

Unbranded Biologics

In addition to reducing the prices of branded insulins, Novo Nordisk is also lowering the prices of unbranded biologics to match the reduced prices of their respective branded counterparts. This ensures that patients have access to affordable insulin options regardless of the brand[1][3][4].

Key Takeaways

• Price Reduction: NovoLog Mix 70/30 will see a 75% price reduction effective January 1, 2024.
• Market Dynamics: The move is part of a broader strategy to balance patient affordability, market dynamics, and policy changes.
• Financial Stability: Despite price cuts, Novo Nordisk's financial performance is expected to remain strong due to its diverse product portfolio and continued innovation.
• Innovation: The company is investing heavily in research and development, including pipeline projects like insulin icodec and CagriSema.
• Sustainability: Novo Nordisk is committed to sustainability and social responsibility, reducing emissions and supporting renewable power transitions.

FAQs

Q: What is the new price of NovoLog Mix 70/30 after the reduction? A: The new prices will be $72.34 for a vial and $139.71 for the FlexPen, representing a 75% reduction from the current list prices[4].

Q: Why is Novo Nordisk reducing the price of its insulin products? A: Novo Nordisk is reducing prices to make insulin more affordable for patients, balance market dynamics, and respond to evolving policy changes[1][3].

Q: How will the price reduction affect Novo Nordisk's financial performance? A: While the price reduction may decrease short-term revenue from NovoLog Mix 70/30, Novo Nordisk's overall financial performance is expected to remain robust due to its diverse product portfolio and continued innovation[2].

Q: What other initiatives is Novo Nordisk undertaking to support patient affordability? A: Novo Nordisk is involved in various access and affordability initiatives, including reducing the prices of unbranded biologics and supporting vulnerable patients with its insulin medicines[2].

Q: What are some of the pipeline projects that Novo Nordisk is currently developing? A: Novo Nordisk is developing several pipeline projects, including insulin icodec, potentially the world’s first once-weekly basal insulin, and the novel combination therapy CagriSema for both diabetes and obesity[2].

Sources

1. Novo Nordisk Press Release: "Novo Nordisk to lower U.S. prices of several pre-filled insulin pens and vials up to 75% for people living with diabetes in January 2024" - PR Newswire.
2. Novo Nordisk Annual Report 2023: Novo Nordisk Annual Report 2023 - Novo Nordisk.
3. Medical Economics: "Novo Nordisk announces insulin price cut for 2024" - Medical Economics.
4. Managed Healthcare Executive: "Novo Nordisk Cuts Price on Several Insulin Products by 75%" - Managed Healthcare Executive.
5. Novo Nordisk Annual Report 2022: Novo Nordisk Annual Report 2022 - Novo Nordisk.