ADMELOG Drug Profile

Summary for Tradename: ADMELOG

High Confidence Patents:	0
Applicants:	1
BLAs:	1
Drug Prices:	Drug price information for ADMELOG
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ADMELOG

See drug prices for ADMELOG

Recent Litigation for ADMELOG

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals, LLC	2021-11-10
Jazz Pharmaceuticals, Inc. v. Avadel CNS Pharmaceuticals, LLC	2021-05-12
Par Pharmaceutical, Inc. v. Eagle Pharmaceuticals, Inc.	2018-05-31

See all ADMELOG litigation

Pharmacology for ADMELOG

Ingredient-type	Insulin
Established Pharmacologic Class	Insulin Analog

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 ADMELOG Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for ADMELOG Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for ADMELOG 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
Sanofi-aventis U.s. Llc	ADMELOG	insulin lispro	Injection	209196	10,004,686	2025-05-23	Patent claims search
Sanofi-aventis U.s. Llc	ADMELOG	insulin lispro	Injection	209196	10,124,040	2034-08-26	Patent claims search
Sanofi-aventis U.s. Llc	ADMELOG	insulin lispro	Injection	209196	10,155,799	2034-07-21	Patent claims search
Sanofi-aventis U.s. Llc	ADMELOG	insulin lispro	Injection	209196	10,172,922	2034-05-08	Patent claims search
Sanofi-aventis U.s. Llc	ADMELOG	insulin lispro	Injection	209196	10,182,561	2024-12-29	Patent claims search
Sanofi-aventis U.s. Llc	ADMELOG	insulin lispro	Injection	209196	10,265,291	2035-07-15	Patent claims search

ADMELOG Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory of Biologic Drugs: A Focus on Admelog

Introduction

Biologic drugs have become a significant segment of the pharmaceutical market, characterized by high growth rates and substantial market share. One such biologic drug is Admelog, an insulin lispro product that has entered the competitive insulin market. This article will delve into the market dynamics and financial trajectory of biologic drugs, with a specific focus on Admelog.

Biologics Market Overview

Biologics are complex, large-molecule drugs that have seen rapid growth over the past decade. In Canada, for instance, biologic sales tripled between 2009 and 2018, reaching $7.7 billion in 2018[1].

Market Share and Growth

Biologics now represent a substantial portion of the pharmaceutical market. In the U.S., biologics account for 42% of the total medicines market, up from 30% in 2014. This growth is driven by the high demand for these drugs and their prolonged market exclusivity compared to small molecules[4].

Admelog: An Insulin Lispro Biosimilar

Admelog, developed by Sanofi, is a biosimilar to Eli Lilly's Humalog, a widely used insulin lispro product. It was approved in December 2017 and entered the market in 2018.

Market Entry and Pricing

Upon its introduction, Admelog had a list price 37% lower than Humalog, but its net price was slightly higher. For example, in 2019, Admelog's list price was $20.39 per 100 units, compared to Humalog's $32.18, but the net price for Admelog was $12.54 versus $10.44 for Humalog[2].

Impact on Insulin Market

The entry of Admelog and other biosimilars has influenced the insulin market dynamics. The net prices of short-acting insulin products, including Admelog, decreased from 2018 to 2019 following their introduction. This trend indicates that biosimilars can lead to lower net prices for payers, although the list prices may not reflect this reduction due to commercial discounts[2].

Financial Performance and Revenue

Revenue Trends

The financial performance of biologic drugs like Admelog is closely tied to their market uptake and pricing strategies. For Admelog, the lower list price compared to Humalog was intended to capture market share. However, the actual revenue impact depends on various factors, including commercial discounts and market competition.

Commercial Discounts

Commercial discounts play a crucial role in the net pricing of biologic drugs. For insulin products, including Admelog, these discounts have increased significantly over the years. From 2012 to 2019, commercial discounts for short-acting insulin products rose from 37.9% to 66.1%, affecting the net revenue realized by manufacturers[2].

Market Dynamics and Competition

Biosimilar Uptake

Despite the potential for cost savings, the uptake of biosimilars in Canada and other countries has been slower than anticipated. In Canada, biosimilar sales accounted for only 1.9% of the $7.7 billion biologic market in 2018. This slow uptake is attributed to various factors, including market exclusivity, patent litigation, and lack of physician and patient awareness[1].

International Comparisons

Internationally, the market dynamics for biologics vary. While some countries have seen significant biosimilar uptake, others, like Canada, have lagged behind. The success of biosimilars is highly dependent on regulatory policies, reimbursement strategies, and market competition[1].

Financial Trajectory of Biologic Companies

ADMA Biologics Example

Companies like ADMA Biologics, which focus on manufacturing, marketing, and developing specialty biologics, provide insights into the financial trajectory of biologic drug manufacturers. ADMA Biologics reported a 78% year-over-year increase in total revenue to $119.8 million in the third quarter of 2024, driven by increased sales of their immunoglobulin products and third-party plasma sales[3].

Revenue Growth and Profitability

The financial success of biologic companies is often tied to the performance of their key products. For ADMA Biologics, the higher-margin product ASCENIV accounted for over 50% of the company's revenue, driving significant margin expansion and earnings growth. This example illustrates how successful biologic products can propel a company's financial trajectory[3].

Key Takeaways

• Biologics Market Growth: Biologics have become a dominant segment of the pharmaceutical market, with significant growth over the past decade.
• Admelog Market Entry: Admelog, as a biosimilar to Humalog, entered the market with a lower list price but higher net price, influencing the insulin market dynamics.
• Commercial Discounts: Commercial discounts significantly impact the net pricing and revenue of biologic drugs like Admelog.
• Biosimilar Uptake: The uptake of biosimilars remains slow in some markets due to various barriers, including market exclusivity and lack of awareness.
• Financial Performance: The financial success of biologic companies is driven by the performance of their key products and strategic market positioning.

FAQs

What is Admelog?

Admelog is a biosimilar to Eli Lilly's Humalog, an insulin lispro product used for managing diabetes.

How has Admelog impacted the insulin market?

Admelog's entry into the market has led to a decrease in the net prices of short-acting insulin products, although its list price is lower but net price slightly higher than Humalog.

What role do commercial discounts play in biologic drug pricing?

Commercial discounts significantly reduce the net prices faced by payers, affecting the revenue realized by manufacturers. For Admelog and other insulin products, these discounts have increased substantially over the years.

Why is the uptake of biosimilars slow in some markets?

The slow uptake of biosimilars is attributed to factors such as market exclusivity, patent litigation, and lack of physician and patient awareness.

How do biologic companies like ADMA Biologics achieve financial success?

Biologic companies achieve financial success through the strong performance of their key products, strategic market positioning, and efficient manufacturing processes, as seen in ADMA Biologics' revenue growth driven by ASCENIV.

Sources

1. Biologics in Canada. Part 1: Market Trends, Canada.ca
2. Estimated Changes in Insulin Prices and Discounts After Entry of Biosimilars, JAMA Health Forum
3. ADMA Biologics Announces Third Quarter 2024 Financial Results, ADMA Biologics
4. Biologics Market Dynamics: Setting the Stage for Biosimilars, Federal Trade Commission