Insulin isophane human - Biologic Drug Details

Summary for insulin isophane human

Tradenames:	2
High Confidence Patents:	2
Applicants:	2
BLAs:	4
Suppliers: see list	3

Pharmacology for insulin isophane human

Established Pharmacologic Class	Insulin
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 insulin isophane human Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for insulin isophane human 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.	NOVOLIN 70/30	insulin isophane human and insulin human	Injection	019991	4,973,318	2008-02-10	Company disclosures
Novo Nordisk Inc.	NOVOLIN 70/30	insulin isophane human and insulin human	Injection	019991	5,462,535		Company disclosures

3) Low Certainty: US Patents for insulin isophane human Derived from Patent Text Search

These patents were obtained by searching patent claims

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Eli Lilly And Company	HUMULIN N	insulin isophane human	Injectable Suspension	018781	10,660,941	2036-02-19	Patent claims search
Novo Nordisk Inc.	NOVOLIN N	insulin isophane human	Injectable Suspension	019959	10,660,941	2036-02-19	Patent claims search
Eli Lilly And Company	HUMULIN 70/30	insulin isophane human and insulin human	Injectable Suspension	019717	10,660,941	2036-02-19	Patent claims search

Insulin isophane human Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Insulin Isophane Human

Introduction

Insulin isophane human, a type of intermediate-acting insulin, plays a crucial role in the management of diabetes. Understanding its market dynamics and financial trajectory is essential for patients, healthcare providers, and pharmaceutical companies.

Global Demand and Prescription Trends

The demand for insulin isophane human is significant, particularly in the United States. According to Statista, in 2022, combinations of human insulin and insulin isophane human were prescribed over 2.2 million times, down from around 2.8 million in the previous year. This trend indicates a substantial market for this type of insulin[1].

Cost and Affordability

One of the critical factors influencing the market dynamics of insulin isophane human is its cost. Human synthetic insulins, including insulin isophane human, are significantly cheaper than analogue insulins. For instance, human insulin can have a retail value as low as $25 per vial, which is up to 10 times less expensive than analogue insulin[2].

Financial Constraints and Insulin Choice

Patients with financial risk factors are more likely to use low-cost human insulins, including insulin isophane human, compared to higher-cost analogue insulins. A study published in the American Journal of Managed Care found that patients with one or more financial risk factors were more likely to use human insulin (88.5% vs 76.7%)[2].

Market Competition and Biosimilars

The entry of biosimilars into the insulin market has significantly impacted the financial trajectory of insulin isophane human. Biosimilars, such as Basaglar (a biosimilar to Lantus), have created competition that drives down prices. A study examining the US sales and net prices of insulin glargine products found that the approval of biosimilars led to a substantial decrease in net prices. For example, the net price per 100 IU of glargine insulin decreased on average by $0.67 per quarter after the biosimilar approval[3].

Impact of Biosimilars on Pricing

Before the approval of biosimilars, list prices for insulin glargine products like Lantus increased significantly. However, after the entry of biosimilars, net prices declined. This trend suggests that competition from biosimilars can lead to more affordable insulin options, including insulin isophane human, although the direct impact on isophane human insulin may vary[3].

Low- and Middle-Income Countries (LMICs)

In LMICs, human insulins, including insulin isophane human, account for a significant portion of the insulin market. According to IQVIA, human insulins account for 58% of the days of therapy for insulins across 32 LMICs. Smaller companies in these regions often offer insulins at lower costs, contributing to a more competitive and affordable market[4].

Insurance and Out-of-Pocket Costs

Insurance coverage and out-of-pocket costs play a crucial role in the financial trajectory of insulin isophane human. Patients with high deductibles or limited prescription coverage may face significant out-of-pocket costs. However, for those with insurance, human insulin may offer lower co-pays compared to analogue insulins, leading to substantial savings[2][5].

Patient Outcomes and Financial Risk

Studies have shown that there are no significant differences in patient outcomes between users of human insulin and analogue insulin, even when accounting for financial risk. This suggests that human insulin, including insulin isophane human, can be an effective and cost-efficient treatment option without compromising patient outcomes[2].

Future Market Trends

The future market for insulin isophane human is likely to be influenced by several factors, including the continued entry of biosimilars, changes in healthcare policies, and the growing demand for affordable diabetes treatments. As the global diabetes prevalence increases, the demand for cost-effective insulins like insulin isophane human is expected to rise.

Key Takeaways

• Cost-Effectiveness: Insulin isophane human is significantly cheaper than analogue insulins, making it a cost-effective option for patients with financial constraints.
• Market Competition: The entry of biosimilars has driven down the prices of insulin products, including insulin isophane human.
• Global Demand: Human insulins, including insulin isophane human, are widely used, especially in LMICs.
• Patient Outcomes: There are no significant differences in patient outcomes between users of human insulin and analogue insulin.
• Insurance and Costs: Insurance coverage and out-of-pocket costs significantly impact the affordability of insulin isophane human.

FAQs

Q: How does the cost of insulin isophane human compare to analogue insulins?

A: Insulin isophane human is significantly cheaper than analogue insulins, with a retail value as low as $25 per vial, compared to up to 10 times more for analogue insulins[2].

Q: What impact do biosimilars have on the pricing of insulin isophane human?

A: The entry of biosimilars has led to a decrease in net prices of insulin products, creating a more competitive market and driving down costs[3].

Q: Are there differences in patient outcomes between users of human insulin and analogue insulin?

A: No, there are no significant differences in patient outcomes between users of human insulin and analogue insulin, even when accounting for financial risk[2].

Q: How does insurance coverage affect the cost of insulin isophane human?

A: Patients with insurance coverage may have lower co-pays for human insulin compared to analogue insulin, leading to substantial savings. However, those with high deductibles or limited coverage may face higher out-of-pocket costs[2][5].

Q: What is the global demand for insulin isophane human?

A: Insulin isophane human is widely used, especially in low- and middle-income countries where human insulins account for 58% of the days of therapy for insulins[4].

Sources

1. Statista: Insulin human combination Rx number U.S. 2014-2022.
2. The American Journal of Managed Care: Low-Cost Insulin for Socially At-Risk Patients.
3. JAMA Internal Medicine: Changes Associated With the Entry of a Biosimilar in the Insulin Market.
4. IQVIA: Understanding Insulin Market Dynamics in Low and Middle Income Countries.
5. American Academy of Family Physicians: Understanding the High Cost of Insulin: What Family Physicians Can Do.