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Last Updated: February 10, 2025

NOVOLOG MIX 50/50 Drug Profile


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Recent Clinical Trials for NOVOLOG MIX 50/50

Identify potential brand extensions & biosimilar entrants

SponsorPhase
Amphastar Pharmaceuticals, Inc.Phase 2/Phase 3
The Cleveland ClinicPhase 4
Boston Medical CenterPhase 3

See all NOVOLOG MIX 50/50 clinical trials

Recent Litigation for NOVOLOG MIX 50/50

Identify key patents and potential future biosimilar entrants

District Court Litigation
Case NameDate
NOVO NORDISK INC. v. RIO BIOPHARMACEUTICALS, INC.2024-01-19
NOVO NORDISK INC. v. DR. REDDY'S LABORATORIES, LTD.2023-11-08
Novo Nordisk Inc. v. Mylan Institutional LLC2019-08-22

See all NOVOLOG MIX 50/50 litigation

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
  2. 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.

  3. General brand-side disclosures
  4. 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.

  5. Patents from broad patent text search
  6. 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 50/50 Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for NOVOLOG MIX 50/50 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 50/50 insulin aspart protamine and insulin aspart Injectable Suspension 021810 ⤷  Free Trial 2013-08-20 Company disclosures
Novo Nordisk Inc. NOVOLOG MIX 50/50 insulin aspart protamine and insulin aspart Injectable Suspension 021810 ⤷  Free Trial 2014-04-08 Company disclosures
Novo Nordisk Inc. NOVOLOG MIX 50/50 insulin aspart protamine and insulin aspart Injectable Suspension 021810 ⤷  Free Trial 2014-12-02 Company disclosures
Novo Nordisk Inc. NOVOLOG MIX 50/50 insulin aspart protamine and insulin aspart Injectable Suspension 021810 ⤷  Free Trial 2013-06-21 Company disclosures
Novo Nordisk Inc. NOVOLOG MIX 50/50 insulin aspart protamine and insulin aspart Injectable Suspension 021810 ⤷  Free Trial 2013-06-21 Company disclosures
>Applicant >Tradename >Biologic Ingredient >Dosage Form >BLA >Patent No. >Estimated Patent Expiration >Source

3) Low Certainty: US Patents for NOVOLOG MIX 50/50 Derived from Patent Text Search

No patents found based on company disclosures

Supplementary Protection Certificates for NOVOLOG MIX 50/50

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
41/2005 Austria ⤷  Free Trial 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 00047 Denmark ⤷  Free Trial PRODUCT NAME: INSULIN ASPART, PROTAMINKRYSTALLISERET
C00214826/01 Switzerland ⤷  Free Trial FORMER REPRESENTATIVE: E. BLUM AND CO. PATENTANWAELTE, CH
132000900885237 Italy ⤷  Free Trial AUTHORISATION NUMBER(S) AND DATE(S): (VEDI NOTE), 20000801;- - -, 20181206
SZ 40/2005 Austria ⤷  Free Trial PRODUCT NAME: NOVOMIX 50 - SUSPENSION, ENTHALTEND LĂ–SLICHES INSULIN ASPART UND PROTAMINKRISTALLISIERTES INSULIN ASPART IM VERHĂ„LTNIS 50:50
>Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Market Dynamics and Financial Trajectory for NovoLog Mix 50/50

Introduction to NovoLog Mix 50/50

NovoLog Mix 50/50, a pre-mixed insulin product from Novo Nordisk, is a crucial medication for managing diabetes. It combines 50% insulin aspart and 50% insulin aspart protamine, providing both rapid and long-acting insulin effects. Understanding the market dynamics and financial trajectory of this product is essential for stakeholders, including patients, healthcare providers, and investors.

Market Context and Competitors

The insulin market is highly competitive, with major players like Novo Nordisk, Eli Lilly, and Sanofi. Recent years have seen significant changes in pricing strategies due to increased stakeholder pressure and regulatory scrutiny.

  • Pricing Adjustments: In March 2023, Novo Nordisk announced a reduction in the U.S. list prices of several insulin products, including NovoLog Mix 50/50, by up to 75%. This move followed similar price cuts by Eli Lilly, highlighting the industry's response to public and governmental pressure to make insulin more affordable[1][4].

Pricing and Cost Implications

New Pricing Structure

As of January 1, 2024, the list price for NovoLog Mix 50/50 will be significantly reduced. The new prices will be $72.34 for a vial and $139.71 for a FlexPen, representing a 75% reduction from the current prices. This adjustment aims to reduce the financial burden on patients and align with the company's commitment to making healthcare more accessible[1].

Impact on Patients

The price reduction is expected to significantly benefit patients, especially those without adequate insurance coverage. For instance, patients who previously paid high out-of-pocket costs will now see substantial savings, making the medication more affordable and increasing adherence to treatment plans.

Retail Partnerships

Novo Nordisk has also partnered with retail giants like CVS and Walmart to offer discounted versions of its insulin products, including NovoLog Mix 50/50. These partnerships have further reduced the cost for patients, making the medication more accessible through various retail channels[4].

Financial Performance of Novo Nordisk

Revenue and Sales Growth

Despite the price reductions, Novo Nordisk has experienced robust sales growth. In 2023, the company reported a 31.3% increase in sales growth as reported, and a 35.6% increase in constant exchange rates. This growth is driven by increased volume sales and the introduction of new products[2].

Operating Profit and Margins

Novo Nordisk's operating profit has seen significant growth, with a 37.1% increase in operating profit as reported and a 43.7% increase in constant exchange rates in 2023. The operating margin has remained strong, at 44.2%, indicating the company's ability to maintain profitability despite pricing adjustments[2].

Research and Development

The company continues to invest heavily in research and development, with R&D costs increasing to 14.0% of sales in 2023. This investment is crucial for developing new treatments and maintaining market competitiveness[2].

Competitive Landscape

Eli Lilly and Other Competitors

Eli Lilly, a major competitor, has also reduced its insulin prices by 70% and expanded its Insulin Value Program to cap patient out-of-pocket costs at $35 or less per month. This competitive pricing environment has forced companies to rethink their pricing strategies to remain competitive[1][4].

Biosimilars and Generics

The introduction of biosimilar insulins and generic versions poses a significant threat to the profitability of branded insulins like NovoLog Mix 50/50. However, Novo Nordisk's strategic pricing and partnerships have helped mitigate this impact to some extent[3].

Future Outlook

Volume-Driven Growth

Novo Nordisk's future revenue growth is expected to be driven mainly by increases in volume sales rather than price increases. This strategy aligns with the company's goal of making insulin more accessible while maintaining profitability[3].

New Product Developments

The company is also investing in new product developments, such as the novel combination therapy CagriSema and insulin icodec, which are in phase 3 development. These innovations are expected to contribute to future revenue growth and maintain Novo Nordisk's market position[2].

Regulatory and Public Pressure

Government Initiatives

Government initiatives and public pressure have played a significant role in driving the recent price reductions in the insulin market. Companies are likely to continue facing scrutiny and may need to adapt their pricing strategies further to comply with regulatory demands and public expectations.

"Novo Nordisk recognizes that some patients find it difficult to pay for healthcare, including insulin. As such, the company remains committed to reducing the burden of out-of-pocket costs, helping transform the complex pricing system, and fostering better pricing predictability."[1]

Key Takeaways

  • Pricing Reductions: NovoLog Mix 50/50 will see a 75% reduction in list prices starting January 1, 2024.
  • Financial Performance: Despite price cuts, Novo Nordisk has reported strong sales and operating profit growth.
  • Competitive Landscape: The insulin market is highly competitive, with significant pricing adjustments by major players.
  • Future Outlook: Volume-driven growth and new product developments are expected to drive future revenue.
  • Regulatory Pressure: Companies are adapting to government initiatives and public pressure to make insulin more affordable.

FAQs

What is the new list price for NovoLog Mix 50/50 starting January 1, 2024?

The new list price for NovoLog Mix 50/50 will be $72.34 for a vial and $139.71 for a FlexPen, representing a 75% reduction from the current prices[1].

How does the pricing reduction affect patients?

The price reduction significantly benefits patients by reducing out-of-pocket costs, making the medication more affordable and increasing treatment adherence.

What is the impact of biosimilar insulins on NovoLog Mix 50/50?

Biosimilar insulins pose a competitive threat, but Novo Nordisk's strategic pricing and retail partnerships have helped mitigate this impact to some extent[3].

What are Novo Nordisk's future growth drivers?

Future revenue growth is expected to be driven mainly by increases in volume sales and new product developments such as CagriSema and insulin icodec[2][3].

How has regulatory pressure influenced the insulin market?

Regulatory pressure and public scrutiny have driven significant price reductions in the insulin market, with companies adapting their pricing strategies to comply with these demands[1][4].

Sources

  1. Managed Healthcare Executive: "Novo Nordisk Cuts Price on Several Insulin Products by 75%."
  2. Novo Nordisk Annual Report 2023: "Novo Nordisk Annual Report 2023."
  3. CBS Research Portal: "Valuation of Novo Nordisk A/S."
  4. GoodRx: "How Much Does Insulin Cost? Here's How 32 Brands and Generics Compare."

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