NOVOLOG MIX 70/30 Drug Profile

Summary for Tradename: NOVOLOG MIX 70/30

High Confidence Patents:	12
Applicants:	1
BLAs:	1
Recent Clinical Trials:	See clinical trials for NOVOLOG MIX 70/30
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for NOVOLOG MIX 70/30

Recent Clinical Trials for NOVOLOG MIX 70/30

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Amphastar Pharmaceuticals, Inc.	Phase 2/Phase 3
The Cleveland Clinic	Phase 4
Boston Medical Center	Phase 3

See all NOVOLOG MIX 70/30 clinical trials

Recent Litigation for NOVOLOG MIX 70/30

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
NOVO NORDISK INC. v. RIO BIOPHARMACEUTICALS, INC.	2024-01-19
NOVO NORDISK INC. v. DR. REDDY'S LABORATORIES, LTD.	2023-11-08
SANOFI-AVENTIS U.S. LLC v. MYLAN N.V.	2017-10-24

See all NOVOLOG MIX 70/30 litigation

Pharmacology for NOVOLOG MIX 70/30

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 NOVOLOG MIX 70/30 Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for NOVOLOG MIX 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.	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
Novo Nordisk Inc.	NOVOLOG MIX 70/30	insulin aspart protamine and insulin aspart	Injectable Suspension	021172		2016-06-20	Company disclosures
Novo Nordisk Inc.	NOVOLOG MIX 70/30	insulin aspart protamine and insulin aspart	Injectable Suspension	021172		2018-01-30	Company disclosures

3) Low Certainty: US Patents for NOVOLOG MIX 70/30 Derived from Patent Text Search

No patents found based on company disclosures

International Patents for NOVOLOG MIX 70/30

Country	Patent Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	9748414
Russian Federation	2091088
Czech Republic	2002927
Japan	4490496
Germany	60043595
Japan	2837956
European Patent Office	1570876

Supplementary Protection Certificates for NOVOLOG MIX 70/30

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
SPC/GB99/045	United Kingdom		SPC/GB99/045: 20060829, EXPIRES: 20110828
CA 2005 00047	Denmark		PRODUCT NAME: INSULIN ASPART, PROTAMINKRYSTALLISERET

NOVOLOG MIX 70/30 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for NovoLog Mix 70/30

Introduction

NovoLog Mix 70/30, a pre-mix insulin product developed by Novo Nordisk, has been a crucial component in the management of diabetes. Recent announcements by Novo Nordisk regarding significant price reductions have marked a significant shift in the market dynamics for this and other insulin products.

Historical Context and Market Position

NovoLog Mix 70/30 is part of Novo Nordisk's portfolio of modern insulins, which have consistently performed well in the market. The company's strong sales growth, particularly in the first half of 2012, was driven by its modern insulins and other products like Victoza (liraglutide), a GLP-1 agonist[5].

Recent Price Reductions

In a move to address patient affordability and market dynamics, Novo Nordisk announced a substantial reduction in the list prices of several insulin products, including NovoLog Mix 70/30. Starting January 1, 2024, the list price of NovoLog Mix 70/30 will be reduced by 75% compared to the current price. This means the new prices will be $72.34 for the vial and $139.71 for the FlexPen[1][3][4].

Impact on Patient Affordability

The price reduction is aimed at reducing the burden of out-of-pocket costs for patients living with diabetes. Novo Nordisk recognizes the difficulties many patients face in affording healthcare, including insulin, and is committed to making these essential medications more accessible. This move aligns with the company's goal of transforming the complex pricing system and fostering better pricing predictability[1][3][4].

Market Dynamics

The decision to lower prices follows similar actions by other major pharmaceutical companies, such as Eli Lilly, which recently reduced its insulin prices by 70% and expanded its Insulin Value Program. This competitive landscape suggests a shift towards greater patient affordability and potentially increased market share for companies that prioritize accessibility[4].

Financial Trajectory

Novo Nordisk's financial performance has been robust, with significant growth in sales and net income over recent years. The company's sales grew by 31.3% in 2023, reaching DKK 232.261 billion, and its operating profit increased by 37.1% to DKK 102.574 billion. The reduction in insulin prices, while potentially impacting short-term revenue, is part of a long-term strategy that balances patient affordability with market dynamics and evolving policy changes[2].

Financial Highlights

• Sales Growth: Novo Nordisk has seen consistent sales growth, with a 31.3% increase in 2023 compared to the previous year[2].
• Operating Profit: The company's operating profit grew by 37.1% in 2023, reflecting strong financial performance despite the planned price reductions[2].
• Free Cash Flow: Novo Nordisk generated DKK 68.326 billion in free cash flow in 2023, enabling attractive capital allocation to shareholders[2].

Product Pipeline and Innovation

Novo Nordisk continues to invest heavily in research and development, with a focus on innovative products. For example, the company is developing insulin icodec, potentially the world’s first once-weekly basal insulin, and has advanced novel combination therapies like CagriSema into phase 3 development for type 2 diabetes and obesity[2].

Stakeholder Response

The price reduction announcement has been well-received by stakeholders, including patients, healthcare providers, and policymakers. Steve Albers, senior vice president of Market Access & Public Affairs at Novo Nordisk, emphasized the company's commitment to patient affordability and its efforts to develop a sustainable path forward in the evolving healthcare landscape[1][3].

Competitive Landscape

The insulin market is highly competitive, with several major players. Novo Nordisk's move to reduce prices is seen as a strategic step to maintain market share and enhance patient access. This competitive pressure is likely to continue, with other companies potentially following suit to remain competitive[4].

Regulatory and Policy Environment

The pricing strategy is also influenced by evolving policy changes. Regulatory pressures and public scrutiny have driven pharmaceutical companies to reconsider their pricing models. Novo Nordisk's actions reflect an adaptation to these changes, aiming to balance patient needs with business sustainability[1][3].

Conclusion

NovoLog Mix 70/30's market dynamics and financial trajectory are significantly influenced by Novo Nordisk's recent price reduction announcement. This move is part of a broader strategy to enhance patient affordability, navigate competitive market pressures, and adapt to evolving regulatory and policy environments. While the short-term financial impact may be notable, the long-term benefits in terms of market share, patient trust, and regulatory compliance are likely to be substantial.

Key Takeaways

• Price Reduction: NovoLog Mix 70/30 prices will be reduced by 75% starting January 1, 2024.
• Patient Affordability: The reduction aims to make insulin more accessible to patients.
• Market Dynamics: The move follows similar actions by other pharmaceutical companies and reflects competitive market pressures.
• Financial Performance: Novo Nordisk's financial trajectory remains strong despite the planned price reductions.
• Innovation: The company continues to invest in innovative products and therapies.

FAQs

1. Why is Novo Nordisk reducing the price of NovoLog Mix 70/30? Novo Nordisk is reducing the price to make insulin more affordable for patients and to address the complex pricing system in the healthcare market.

2. What are the new prices for NovoLog Mix 70/30? The new prices will be $72.34 for the vial and $139.71 for the FlexPen, representing a 75% reduction from the current prices.

3. How does this price reduction affect Novo Nordisk's financial performance? While the price reduction may impact short-term revenue, it is part of a long-term strategy to balance patient affordability with market dynamics and evolving policy changes.

4. What other insulin products are affected by the price reduction? The price reduction applies to several insulin products, including Levemir, Novolin, NovoLog, and their respective unbranded biologics.

5. How does this move impact the competitive landscape in the insulin market? The move is likely to increase competitive pressure on other pharmaceutical companies to reduce their insulin prices, enhancing patient access and potentially altering market share dynamics.

Sources

1. Novo Nordisk to lower U.S. prices of several pre-filled insulin pens ... - PR Newswire
2. Novo Nordisk Annual Report 2023 - Novo Nordisk
3. Novo Nordisk announces insulin price cut for 2024 - Medical Economics
4. Novo Nordisk Cuts Price on Several Insulin Products by 75% - Managed Healthcare Executive
5. Victoza Spearheads Strong Performance for Novo Nordisk in H1 - S&P Global Market Intelligence