NOVOLOG MIX 70/30 Drug Profile

Summary for Tradename: NOVOLOG MIX 70/30

High Confidence Patents:	17
Applicants:	1
BLAs:	1
Recent Clinical Trials:	See clinical trials for NOVOLOG MIX 70/30

Recent Clinical Trials for NOVOLOG MIX 70/30

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Xentria, Inc.	PHASE1
Amphastar Pharmaceuticals, Inc.	Phase 2/Phase 3
The Cleveland Clinic	Phase 4

See all NOVOLOG MIX 70/30 clinical trials

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. DrugPatentWatch analysis and company disclosures

These patents were identified from searching various sources, including 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 DrugPatentWatch Analysis and 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	5,547,930	2013-09-28	DrugPatentWatch analysis and company disclosures
Novo Nordisk Inc.	NOVOLOG MIX 70/30	insulin aspart protamine and insulin aspart	Injectable Suspension	021172	5,618,913	2006-08-29	DrugPatentWatch analysis and company disclosures
Novo Nordisk Inc.	NOVOLOG MIX 70/30	insulin aspart protamine and insulin aspart	Injectable Suspension	021172	5,693,027	2014-09-26	DrugPatentWatch analysis and company disclosures
Novo Nordisk Inc.	NOVOLOG MIX 70/30	insulin aspart protamine and insulin aspart	Injectable Suspension	021172	5,834,422	2016-12-11	DrugPatentWatch analysis and company disclosures
Novo Nordisk Inc.	NOVOLOG MIX 70/30	insulin aspart protamine and insulin aspart	Injectable Suspension	021172	5,840,680	2016-12-11	DrugPatentWatch analysis and company disclosures
Novo Nordisk Inc.	NOVOLOG MIX 70/30	insulin aspart protamine and insulin aspart	Injectable Suspension	021172	5,866,538	2017-06-20	DrugPatentWatch analysis and 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)	9500550
Japan	4472522
Netherlands	300212
Ukraine	56256
Poland	374182
Denmark	0499613

Supplementary Protection Certificates for NOVOLOG MIX 70/30

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C00214826/01	Switzerland		FORMER REPRESENTATIVE: E. BLUM AND CO. PATENTANWAELTE, CH
C990042	Netherlands		PRODUCT NAME: INSULIN ASPART; REGISTRATION NO/DATE: EU/1/99/119/001 - EU/1/99/119/005 19990907
99C0044	Belgium		PRODUCT NAME: INSULIN-ASPART; NAT. REGISTRATION NO/DATE: EU/1/99/119/001 19990907; FIRST REGISTRATION: CH 55045 01 19990615
SPC/GB99/045	United Kingdom		SPC/GB99/045: 20060829, EXPIRES: 20110828
SZ 40/2005	Austria		PRODUCT NAME: NOVOMIX 50 - SUSPENSION, ENTHALTEND LÖSLICHES INSULIN ASPART UND PROTAMINKRISTALLISIERTES INSULIN ASPART IM VERHÄLTNIS 50:50
SZ 41/2005	Austria		PRODUCT NAME: NOVOMIX 70 - SUSPENSION, ENTHALTEND LÖSLICHES INSULIN ASPART UND PROTAMINKRISTALLISIERTES INSULIN ASPART IM VERHÄLTNIS 70:30

Market Dynamics and Financial Trajectory for NOVOLOG MIX 70/30

Last updated: September 23, 2025

Introduction

NOVOLOG MIX 70/30 is a premixed insulin formulation combining 70% rapid-acting insulin aspart and 30% insulin aspart protamine. Manufactured by Novo Nordisk, it addresses a critical segment in diabetes management—patients requiring flexible, mealtime insulin coverage. As the global diabetes epidemic persists, understanding the evolving market landscape and financial future of NOVOLOG MIX 70/30 offers essential insights for stakeholders. This analysis examines market forces, regulatory influences, competitive positioning, and revenue projections shaping NOVOLOG MIX 70/30’s trajectory.

Global Market Landscape for Insulin and Premixed Formulations

Rising Diabetes Prevalence

The International Diabetes Federation (IDF) reports over 537 million adults worldwide lived with diabetes in 2021, projected to reach 643 million by 2030 (IDF, 2021). The surge predominantly affects middle- and low-income regions, driving increased demand for insulin therapies, including premixed formulations that simplify dosing regimens.

Preference for Premixed Insulins

Premixed insulins like NOVOLOG MIX 70/30 offer convenient dosing by combining rapid-acting and intermediate components in a single injection, appealing to patients seeking simplicity without frequent titration. Their usage accounts for approximately 20-25% of basal-bolus insulin prescriptions globally (IMS Health, 2020), with a growing trend owing to patient compliance considerations.

Market Share Trends

The global insulin market is projected to reach $37.3 billion by 2027, growing at a CAGR of 8% (Fortune Business Insights, 2022). Premixed insulin's segment is expected to maintain steady growth, driven by its acceptance in both developed and developing markets. Novo Nordisk holds an estimated 40-45% market share within premixed insulins, bolstered by its broad portfolio and brand recognition.

Market Dynamics Influencing NOVOLOG MIX 70/30

Regulatory Environment

Regulatory pathways are increasingly stringent, especially regarding biosimilar entrants aiming to displace branded insulins. However, NOVOLOG MIX 70/30 benefits from regulatory exclusivities and established approvals in major markets like the U.S., EU, and Japan. The FDA’s recent re-evaluation of insulin biosimilars underscores the importance of maintaining R&D investments to uphold market access.

Pricing and Reimbursement Landscape

Price pressures are intensifying, especially amid rising healthcare costs and payor pushback against high-cost biologics. Novolog Mix 70/30's affordability and reimbursement status significantly influence its market penetration. In the U.S., Medicaid and private insurers often favor cost-effective biosimilars, constraining revenue growth for branded formulations. Conversely, higher-income regions with comprehensive reimbursement policies offer more robust margins.

Innovations & Competitive Products

The insulin market is witnessing innovations such as ultra-long-acting insulins (e.g., Tresiba), biosimilar insulins, and technological integration (smart pens, pumps). While these advancements enhance diabetes management, they could cannibalize premixed insulin usage by offering personalized, flexible regimens. However, NOVOLOG MIX 70/30's unique formulation remains competitive owing to its established efficacy and patient familiarity.

Patient Demographics and Market Segments

Type 2 diabetes prevalence fuels the demand for premixed insulins. As these patients often require simplified regimens, NOVOLOG MIX 70/30 is positioned as a preferred option in clinics, hospitals, and outpatient care. Additionally, the aging population and urbanization trends in emerging markets expand the usage base.

Financial Trajectory and Revenue Forecasts

Historical Performance

Over the past five years, Novo Nordisk’s insulin portfolio has grown at an average CAGR of 7-8%, with the premixed segment contributing substantially. Product sales of NovoLOG Mix 70/30 have exhibited resilience despite market pressures, with annual revenues surpassing $1.5 billion globally (Novo Nordisk Annual Report, 2022).

Factors Driving Future Revenue

• Market Penetration: Expansion into emerging markets (e.g., China, India) where insulin access is increasing due to government initiatives will bolster volumes.
• Product Differentiation: Its well-established profile and compatibility with existing treatment algorithms support sustained demand.
• Regulatory Approvals: Continuous approval of new formulations and indications can unlock additional markets or patient segments.
• Pricing Strategies: Navigating pricing amid biosimilar competition and reimbursement negotiations is critical for maximizing margins.

Projected Growth

Based on current market trends, Novo Nordisk anticipates a 5-7% annual growth rate for NOVOLOG MIX 70/30 revenues over the next five years. This translates into projected global sales exceeding $2.3 billion by 2028, assuming steady market share retention and market expansion. Price erosion from biosimilars may temper growth, but increased volumes and emerging market penetration are expected to compensate.

Risks and Challenges

• Biosimilar Competition: Entry of biosimilar insulins could undercut pricing, putting pressure on profit margins.
• Regulatory Changes: Stringent approval pathways or reimbursement reforms could delay market access.
• Innovative Therapeutics: Advances like ultra-long-acting insulins and opioid antagonists might shift prescribing behaviors.
• Market Saturation: Higher-income markets nearing saturation may limit further growth unless new indications or formulations are developed.

Market Outlook and Strategic Opportunities

To sustain growth, Novo Nordisk must prioritize strategic initiatives like expanding into underserved geographies, optimizing pricing strategies, and leveraging digital health integrations. Moreover, investing in next-generation premixed or combination insulins could create new revenue streams and safeguard market share.

Key Takeaways

• The global demand for premixed insulins such as NOVOLOG MIX 70/30 remains robust, driven by the rising prevalence of diabetes.
• Market dynamics favor continued growth, though margin pressures from biosimilars and technological shifts pose risks.
• Novo Nordisk’s strong market position and ongoing expansion into emerging markets underpin its revenue trajectory.
• Strategic investments in innovation, access, and digital health are vital for maintaining competitiveness.
• Revenue projections suggest 5-7% annual growth over the next five years, with potential to surpass $2.3 billion globally.

FAQs

1. How does NOVOLOG MIX 70/30 compare to other premixed insulins?
NOVOLOG MIX 70/30 offers rapid-acting insulin aspart combined with insulin aspart protamine, providing rapid onset and intermediate duration. Its efficacy, speed, and compatibility with existing treatment protocols make it competitive against other premixed formulations like Humalog Mix 75/25. However, clinician preference and regional formulary decisions influence choice.

2. What factors are most likely to influence the future sales of NOVOLOG MIX 70/30?
Key factors include emerging biosimilar competition, regulatory approval processes, reimbursement policies, market penetration into emerging economies, and innovation in insulin formulations.

3. Will biosimilars threaten NOVOLOG MIX 70/30’s market share?
Yes. Biosimilars offer cost advantages that can erode profitability and market share. However, branded formulations like NOVOLOG MIX 70/30 benefit from physician familiarity, brand trust, and patent protections in certain regions, providing some insulation.

4. How is digital health impacting the adoption of premixed insulins?
Digital health tools, such as smart pens and insulin pumps, enable more precise dosing and monitoring, promoting personalized therapy. While this may favor flexible insulins over premixed formulations, the simplicity of premixed insulins remains attractive for certain patient segments.

5. What strategic actions should Novo Nordisk pursue to sustain growth?
Focus on expanding into emerging markets, invest in biosimilar competition readiness, innovate within the premixed insulin space, and enhance digital healthcare offerings to improve adherence and outcomes.

Conclusion

NOVOLOG MIX 70/30 occupies a resilient position within the dynamic insulin market landscape. While challenges like biosimilar entry and technological shifts loom, strategic expansion and innovation can sustain its financial trajectory. Stakeholders should monitor regulatory developments, market penetration efforts, and evolving patient needs to capitalize on upcoming opportunities and safeguard long-term profitability.

---

Sources Cited
[1] International Diabetes Federation (IDF). Diabetes Atlas, 2021.
[2] Fortune Business Insights. Global Insulin Market Report, 2022.
[3] IMS Health. Global Trends in Diabetes Pharmacotherapy, 2020.
[4] Novo Nordisk. Annual Report 2022.