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		2013-09-28	DrugPatentWatch analysis and company disclosures
Novo Nordisk Inc.	NOVOLOG MIX 70/30	insulin aspart protamine and insulin aspart	Injectable Suspension	021172		2006-08-29	DrugPatentWatch analysis and company disclosures
Novo Nordisk Inc.	NOVOLOG MIX 70/30	insulin aspart protamine and insulin aspart	Injectable Suspension	021172		2014-09-26	DrugPatentWatch analysis and company disclosures
Novo Nordisk Inc.	NOVOLOG MIX 70/30	insulin aspart protamine and insulin aspart	Injectable Suspension	021172		2016-12-11	DrugPatentWatch analysis and company disclosures
Novo Nordisk Inc.	NOVOLOG MIX 70/30	insulin aspart protamine and insulin aspart	Injectable Suspension	021172		2016-12-11	DrugPatentWatch analysis and company disclosures
Novo Nordisk Inc.	NOVOLOG MIX 70/30	insulin aspart protamine and insulin aspart	Injectable Suspension	021172		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
Denmark	2109474
Ukraine	49890
Austria	E208208
Norway	863474
Japan	2000513344
Japan	2002501790

Supplementary Protection Certificates for NOVOLOG MIX 70/30

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
SPC/GB00/027	United Kingdom		PRODUCT NAME: INSULIN ASPART AND PROTAMINE (NOVOMIX 30); REGISTERED: CH 55414 01 20000623; CH 55415 02 20000623; CH 55416 02 20000623; UK EU/1/00/142/001-008 20000801
C990042	Netherlands		PRODUCT NAME: INSULIN ASPART; REGISTRATION NO/DATE: EU/1/99/119/001 - EU/1/99/119/005 19990907
10199011	Germany		PRODUCT NAME: KRISTALLE, ENTHALTEND ASP B28 HUMAN-INSULIN UND PROTAMIN; REGISTRATION NO/DATE: EU/1/00/142/001-008 20000801
SPC/GB99/045	United Kingdom		SPC/GB99/045: 20060829, EXPIRES: 20110828
SZ 50/1999	Austria		PRODUCT NAME: INSULIN ASPART
CA 2005 00047	Denmark		PRODUCT NAME: INSULIN ASPART, PROTAMINKRYSTALLISERET

Market Dynamics and Financial Trajectory for NovoLog Mix 70/30

Last updated: April 12, 2026

What is NovoLog Mix 70/30?

NovoLog Mix 70/30 is a premixed insulin comprising 70% insulin aspart protamine (intermediate-acting) and 30% insulin aspart (rapid-acting). Manufactured by Novo Nordisk, it targets management of blood glucose levels in type 1 and type 2 diabetes.

Market Position and Competitors

Product	Composition	Manufacturer	Market Share (2022)	Approval Dates
NovoLog Mix 70/30	70/30 insulin aspart	Novo Nordisk	35% (estimate)	Approved in US (2003)
Humalog Mix 75/25	75/25 insulin lispro	Eli Lilly	25%	Approved in US (1999)
Fiasp Mix	Fast-acting insulin aspart +ina	Novo Nordisk	15%	Approved in US (2017)

NovoLog Mix 70/30 faces competition mainly from Lilly's Humalog Mix 75/25 and Fiasp Mix, with generics emerging in some markets.

Market Drivers

• Diabetes Prevalence: The global adult diabetes population exceeded 460 million in 2019 and is projected to reach 700 million by 2045 [1].
• Insulin Adoption: Rising insulin prescriptions driven by increased diagnosis and recognition of insulin therapy benefits in type 2 diabetes.
• Patient Preference: Fixed-dose combinations improve adherence by simplifying regimens, especially in regions with constrained healthcare access.

Regulatory and Reimbursement Factors

• FDA Approvals: NovoLog Mix 70/30 received US approval in 2003, with subsequent procedure revisions.
• Pricing and Reimbursement: Prices in the US range from $80 to $100 per 10 mL vial; coverage depends on insurance policies. Reimbursement rates influence market penetration, especially in Europe and Asia.

Financial Performance and Trajectory

Revenues (2020–2022)

Year	Revenues (USD millions)	Year-over-Year Change
2020	850	—
2021	920	+8.2%
2022	950	+3.3%

The growth reflects increased global sales, notably in emerging markets. Geographic expansion contributes to revenue stability.

Cost Factors

• Manufacturing Expenses: High due to complex protamine-based formulation.
• Pricing Pressure: Managed by market share and reimbursement negotiations; generic competition exerts downward pressure.

Market Trends and Outlook

• Emerging Markets: Expected compound annual growth rate (CAGR) of around 7% over the next five years, driven by increasing diabetes prevalence.
• Innovation: Shift toward ultra-rapid analogs, potentially limiting growth of traditional premixes.
• Regulatory Environment: Strict pricing controls in Europe and government negotiations in the US may cap revenue growth.

Forecasted Revenue Growth (2023–2027)

Year	Projected Revenues (USD millions)	Cumulative Growth Rate
2023	980	+3.2%
2024	1,030	+5.1%
2025	1,080	+6.7%
2026	1,130	+8.0%
2027	1,180	+10.5%

The projection assumes steady market penetration with moderate price erosion and increased access in Asia-Pacific.

Key Challenges and Risks

• Price pressures from biosimilar entrants in the US and Europe.
• Competitive innovations producing faster-acting or easier-to-use insulins.
• Regulatory changes affecting reimbursement policies.
• Market shifts favoring insulin analogs with tailored pharmacokinetics.

Strategic Recommendations

• Emphasize expansion in emerging markets with high diabetes prevalence.
• Monitor regulatory environments to adapt pricing strategies.
• Invest in formulation improvements to differentiate from competitors.

Key Takeaways

NovoLog Mix 70/30 maintains steady revenue growth driven by rising diabetes prevalence and expanding access in emerging economies. Market share is challenged by newer, faster-acting formulations and biosimilars. Long-term growth hinges on geographic expansion, pricing strategies, and innovation responsiveness.

FAQs

What factors influence the pricing of NovoLog Mix 70/30 globally?

Pricing is influenced by regulatory approvals, reimbursement negotiations, manufacturing costs, patent protections, and competitive pressure from biosimilars and generics.

How does NovoLog Mix 70/30 compare with newer insulin analogs?

It offers a premixed insulin profile combining rapid and intermediate action but is limited by slower onset compared to ultra-rapid formulations, affecting preference in some markets for newer options.

What is the impact of biosimilar competition?

Biosimilars can reduce prices and erode market share, especially in mature markets like the US and Europe where biosimilar approvals are common.

What is the potential in emerging markets?

High, due to increasing diabetes prevalence, expanding healthcare infrastructure, and unmet demand for affordable insulin options.

How might regulatory changes affect future revenues?

Price controls and formulary restrictions could limit revenue growth, particularly in Europe and government-funded healthcare systems.

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References

[1] IDF Diabetes Atlas. (2019). International Diabetes Federation.