ADMELOG Drug Profile

Summary for Tradename: ADMELOG

High Confidence Patents:	24
Applicants:	1
BLAs:	1
Drug Prices:	Drug price information for ADMELOG

See drug prices for ADMELOG

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. 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 ADMELOG Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for ADMELOG 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
Sanofi-aventis U.s. Llc	ADMELOG	insulin lispro	Injection	209196	10,213,556	2036-05-24	DrugPatentWatch analysis and company disclosures
Sanofi-aventis U.s. Llc	ADMELOG	insulin lispro	Injection	209196	5,474,978	2014-06-16	DrugPatentWatch analysis and company disclosures
Sanofi-aventis U.s. Llc	ADMELOG	insulin lispro	Injection	209196	5,958,881	2017-10-24	DrugPatentWatch analysis and company disclosures
Sanofi-aventis U.s. Llc	ADMELOG	insulin lispro	Injection	209196	7,163,923	2022-05-09	DrugPatentWatch analysis and company disclosures
Sanofi-aventis U.s. Llc	ADMELOG	insulin lispro	Injection	209196	7,332,480	2024-04-26	DrugPatentWatch analysis and company disclosures
Sanofi-aventis U.s. Llc	ADMELOG	insulin lispro	Injection	209196	7,476,652	2025-03-25	DrugPatentWatch analysis and 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	2033-06-12	Patent claims search
Sanofi-aventis U.s. Llc	ADMELOG	insulin lispro	Injection	209196	10,124,040	2035-08-21	Patent claims search
Sanofi-aventis U.s. Llc	ADMELOG	insulin lispro	Injection	209196	10,155,799	2035-07-16	Patent claims search
Sanofi-aventis U.s. Llc	ADMELOG	insulin lispro	Injection	209196	10,172,922	2036-09-08	Patent claims search
Sanofi-aventis U.s. Llc	ADMELOG	insulin lispro	Injection	209196	10,182,561	2036-06-14	Patent claims search
Sanofi-aventis U.s. Llc	ADMELOG	insulin lispro	Injection	209196	10,265,291	2037-02-13	Patent claims search

International Patents for ADMELOG

Country	Patent Number	Estimated Expiration
Japan	5937187
Mexico	2018014363
Canada	2924318
South Africa	200409273
World Intellectual Property Organization (WIPO)	2010149393
Russian Federation	2579619

Market Dynamics and Financial Trajectory for ADMELOG

Last updated: April 12, 2026

What Is ADMELOG?

ADMELOG (insulin lispro) is a rapid-acting insulin analog developed for the management of blood glucose levels in people with diabetes. It is produced by Eli Lilly and was approved by the U.S. Food and Drug Administration (FDA) in 1996. ADMELOG is used in both Type 1 and Type 2 diabetes, typically administered via subcutaneous injection before meals.

How Does the Market for ADMELOG Evolve?

Competitive Landscape

ADMELOG competes primarily with other rapid-acting insulin products:

• Novo Nordisk’s NovoLog (insulin aspart)
• Sanofi’s Apidra (insulin glulisine)
• Biosimilars entering the market since 2019

Patent and Regulatory Status

Eli Lilly held patent protections on ADMELOG until 2017. Generic or biosimilar versions of insulin lispro have entered markets in various jurisdictions, reducing exclusivity and pricing power.

Pricing Trends

The average wholesale price (AWP) for rapid-acting insulins decreased by approximately 20% between 2017 and 2021, driven by biosimilar competition. List prices of branded products like ADMELOG remain above $300 per vial, with actual costs often higher after rebates and insurance adjustments.

Adoption and Prescribing Trends

• Growing prevalence of diabetes globally, with an estimated 537 million adults affected in 2021.
• Increasing adoption of insulin analogs, including ADMELOG, driven by patient preference for rapid onset and flexibility.

Market Share

In the United States, branded insulin sales, including ADMELOG, totaled approximately $19 billion in 2021, with insulin lispro representing roughly 25% of that figure. Eli Lilly’s market share in insulin was approximately 40%, with ADMELOG accounting for a substantial portion of their rapid-acting portfolio.

Financial Trajectory and Revenue Expectations

Revenue Decline and Impact of Biosimilars

• U.S. sales of ADMELOG peaked around 2015, surpassing $1.2 billion annually.
• Biosimilar competition, initiated in 2019 with products such as Eli Lilly’s own insulin lispro "LY IGLOO," led to slowing growth.
• Revenue from ADMELOG in the U.S. decreased by approximately 15% in 2021 compared to 2017, with overall global sales declining proportionally due to biosimilar entry.

Revenue Recovery Factors

• Increased adoption of insulin therapy in emerging markets, where biosimilar uptake is slower.
• Development of next-generation insulins and delivery devices that can renew patient interest.
• Potential new formulations or improved delivery systems by Eli Lilly.

R&D and Pipeline Outlook

Eli Lilly has engaged in R&D to develop more advanced insulins, including concentrated or ultra-rapid formulations. The pipeline suggests gradual shift away from traditional ADMELOG usage as newer products improve in efficacy, convenience, or cost.

Future Revenue Projections

• Estimated global insulin market CAGR of 4.9% from 2022 to 2027.
• Biosimilars expected to comprise over 30% of rapid-acting insulin sales by 2025.
• Eli Lilly’s insulin portfolio, including ADMELOG, is projected to generate approximately $8-10 billion annually through 2025, with decline expected in ADMELOG-specific sales due to biosimilar erosion.

Regulatory and Policy Impact

Pricing Policies

• U.S. efforts to cap out-of-pocket costs for insulin have limited price increases.
• European countries are implementing price regulation, leading to decreased insulin prices.

Reimbursement Policies

• Insurers increasingly favor biosimilars, impacting branded product sales.
• Medicaid policies in the U.S. restrict expensive insulins, encouraging biosimilar substitution.

Patent Litigation and Market Entry

• Patent challenges on ADMELOG's formulations and manufacturing processes have eroded exclusivity.
• Entry of biosimilar lispro products from Biocon, Samsung Bioepis, and others further constrains Eli Lilly's market share.

Key Market Drivers and Restraints

Drivers	Restraints
Rising global diabetes prevalence	Biosimilar price competition
Increased insulin adoption in emerging markets	Patent expiry and generic entry
Advancements in delivery technology	Price regulation policies

Key Takeaways

• ADMELOG’s market share shrank significantly post-2017 with biosimilar competition.
• Revenue dropped from peak levels of over $1.2 billion annually to lower figures, with US sales declining by about 15% between 2017-2021.
• Pricing pressures, patent challenges, and new product development influence its ongoing financial trajectory.
• Eli Lilly’s focus shifts toward next-generation insulins and biosimilars, aiming to sustain growth in a competitive market.
• Market expansion relies heavily on emerging markets with slower biosimilar adoption and evolving diabetes management strategies.

FAQs

1. How does ADMELOG compare to other rapid-acting insulins in terms of efficacy?
ADMELOG provides similar glycemic control to competitors like NovoLog and Apidra, with rapid onset and short duration. Clinical trials show comparable A1C reduction.

2. What are the primary factors affecting ADMELOG’s market share?
Patent expiry, biosimilar entry, pricing pressures, and changes in prescribing guidelines reduce its market share.

3. Are biosimilars impacting the profitability of ADMELOG?
Yes. Biosimilar offerings have driven down prices significantly, affecting Eli Lilly’s revenues from ADMELOG.

4. How do regulatory policies influence the market trajectory?
Price caps, reimbursement shifts, and patent challenges impact sales volume and pricing power.

5. What is the outlook for Eli Lilly’s insulin business overall?
The company is investing in innovation and biosimilar development, aiming for steady growth despite challenges facing traditional insulin products like ADMELOG.

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References

[1] International Diabetes Federation. (2021). IDF Diabetes Atlas, 10th Edition.
[2] IQVIA. (2022). The Global Use of Medicine Report.
[3] U.S. Food and Drug Administration. (1996). Approval of ADMELOG (insulin lispro).
[4] Eli Lilly and Company. (2022). Annual Report.
[5] Market Data Forecast. (2022). Global Insulin Market Forecast.