HUMALOG MIX 50 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 HUMALOG MIX 50 Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for HUMALOG MIX 50 Derived from Company Disclosures

No patents found based on company disclosures

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

No patents found based on company disclosures

HUMALOG MIX 50 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Humalog Mix 50/50

Introduction

Humalog Mix 50/50, a pre-mixed insulin developed by Eli Lilly and Company, is a significant player in the diabetes management market. This article delves into the market dynamics and financial trajectory of this biologic drug, providing insights into its role, competition, and financial performance.

What is Humalog Mix 50/50?

Humalog Mix 50/50 is a combination of 50% insulin lispro protamine suspension and 50% insulin lispro injection (rDNA origin). It is designed to control high blood sugar in patients with diabetes, particularly those who need improved blood sugar control at mealtime and between meals[1].

Market Position and Competition

In the diabetes market, Humalog Mix 50/50 competes primarily with other short-acting and premixed insulins. Eli Lilly's main competitor in the short-acting insulin market is Novo Nordisk's NovoLog. The competition between these two has shifted from sales force efforts to competing on payer access and formulary inclusion[4].

Premixed Insulin Market

The premixed insulin market, where Humalog Mix 50/50 is positioned, is relatively small compared to other insulin categories. However, this market remains crucial as it offers a convenient dosing option for patients who need both rapid and intermediate-acting insulin control[4].

Clinical Benefits and User Preferences

Humalog Mix 50/50 provides several clinical benefits, including rapid onset of action and the convenience of dosing immediately before a meal. This product has been favored by patients due to its ease of use and effective blood sugar control. For instance, a study in Canada showed that patients preferred Humalog Mix 25 (a similar product) over human 30/70 insulin and were willing to pay for it[5].

Financial Performance

Revenue Trends

In recent years, the revenue from Humalog has shown mixed trends. For the fourth quarter of 2022, worldwide Humalog revenue decreased by 9% compared to the same period in 2021, reaching $548.3 million. However, in the U.S., Humalog revenue increased by 8% to $336.0 million during the same period[2].

Contribution to Eli Lilly's Portfolio

Humalog, including its premixed formulations like Humalog Mix 50/50, remains a significant contributor to Eli Lilly's revenue. In 2016, the Humalog portfolio generated over $2.5 billion in sales, highlighting its importance in the company's diabetes treatment offerings[4].

Market Dynamics and Biosimilar Competition

Biologics Market Growth

Biologics, including insulins like Humalog, have become a growing share of the pharmaceutical market. By 2019, biologics represented 42% of the total medicines market, up from 30% in 2014. This growth is driven by their efficacy and the increasing prevalence of chronic diseases like diabetes[3].

Biosimilar Competition

The biologics market is increasingly exposed to biosimilar competition. By the end of 2019, 17% of the biologics market was accessible to biosimilars, with biosimilars achieving a 20% share in those markets. However, insulin products like Humalog Mix 50/50 have been slower to face significant biosimilar competition compared to other biologics[3].

Pricing and Access

Payer Negotiations

The market for insulins, including premixed formulations like Humalog Mix 50/50, is heavily influenced by payer negotiations. The fortunes of these products are often tied to their short-acting insulin counterparts during these negotiations. This dynamic has led to intense competition between Eli Lilly and Novo Nordisk in terms of securing favorable formulary positions and pricing agreements[4].

Future Outlook

Market Growth and Competition

The diabetes market is expected to continue growing, driven by the increasing prevalence of diabetes globally. However, the market will also face increased competition from biosimilars and new therapeutic options. Eli Lilly's ability to maintain market share will depend on its continued innovation, strong payer relationships, and the clinical differentiation of its products[3][4].

Regulatory and Clinical Developments

Eli Lilly continues to invest in research and development, including pipeline advancements in diabetes treatments. The company's recent approvals and regulatory submissions for other diabetes-related products, such as Jardiance and Mounjaro, indicate a strong commitment to the diabetes market and potential future growth opportunities[2].

Key Takeaways

• Market Position: Humalog Mix 50/50 is a significant player in the premixed insulin market, competing primarily with Novo Nordisk's products.
• Financial Performance: Despite some revenue fluctuations, Humalog remains a crucial part of Eli Lilly's portfolio, contributing significantly to the company's revenue.
• Biosimilar Competition: The biologics market, including insulins, is increasingly exposed to biosimilar competition, though insulin products have been slower to face this challenge.
• Payer Dynamics: Payer negotiations and formulary inclusion are critical factors in the market success of Humalog Mix 50/50.
• Future Outlook: The diabetes market is expected to grow, but competition from biosimilars and new therapies will be a key challenge.

FAQs

What is Humalog Mix 50/50 used for?

Humalog Mix 50/50 is used to control high blood sugar in patients with diabetes, providing both rapid and intermediate-acting insulin control.

How does Humalog Mix 50/50 compare to other insulins?

Humalog Mix 50/50 competes primarily with Novo Nordisk's NovoLog in the short-acting insulin market and is favored for its convenience and effective blood sugar control.

What are the financial trends for Humalog Mix 50/50?

In Q4 2022, worldwide Humalog revenue decreased by 9%, but U.S. revenue increased by 8%. The product remains a significant contributor to Eli Lilly's revenue.

Is Humalog Mix 50/50 facing biosimilar competition?

While the biologics market is increasingly exposed to biosimilar competition, insulin products like Humalog Mix 50/50 have been slower to face significant biosimilar competition.

What is the future outlook for Humalog Mix 50/50?

The diabetes market is expected to grow, but Humalog Mix 50/50 will face increased competition from biosimilars and new therapeutic options. Eli Lilly's continued innovation and strong payer relationships will be crucial for maintaining market share.

Sources

1. Lilly Launches Humalog(R) Mix50/50(TM) Insulin in United States. Eli Lilly and Company.
2. Lilly Reports Fourth-Quarter 2022 Financial Results, Core Business. Eli Lilly and Company.
3. Biologics Market Dynamics: Setting the Stage for Biosimilars. Federal Trade Commission.
4. Eli Lilly in the Diabetes Market. Ozmosi Pharmaceutical Data.
5. The economic value of a new insulin preparation, Humalog Mix 25. PubMed.