ENBREL MINI Drug Profile

Summary for Tradename: ENBREL MINI

High Confidence Patents:	0
Applicants:	1
BLAs:	1
Drug Prices:	Drug price information for ENBREL MINI

See drug prices for ENBREL MINI

Pharmacology for ENBREL MINI

Mechanism of Action	Tumor Necrosis Factor Receptor Blocking Activity
Established Pharmacologic Class	Tumor Necrosis Factor Blocker

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 ENBREL MINI Derived from Brand-Side Litigation

No patents found based on brand-side litigation

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

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Immunex Corporation	ENBREL MINI	etanercept	Injection	103795	10,307,483	2036-10-21	Company disclosures
Immunex Corporation	ENBREL MINI	etanercept	Injection	103795	11,491,223		Company disclosures
Immunex Corporation	ENBREL MINI	etanercept	Injection	103795	5,395,760	2012-03-07	Company disclosures
Immunex Corporation	ENBREL MINI	etanercept	Injection	103795	5,605,690	2014-02-25	Company disclosures
Immunex Corporation	ENBREL MINI	etanercept	Injection	103795	5,712,155	2009-09-05	Company disclosures

3) Low Certainty: US Patents for ENBREL MINI 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
Immunex Corporation	ENBREL MINI	etanercept	Injection	103795	10,010,585	2034-06-16	Patent claims search
Immunex Corporation	ENBREL MINI	etanercept	Injection	103795	10,016,338	2033-03-11	Patent claims search
Immunex Corporation	ENBREL MINI	etanercept	Injection	103795	10,028,940	2033-08-13	Patent claims search
Immunex Corporation	ENBREL MINI	etanercept	Injection	103795	10,047,141	2039-02-26	Patent claims search
Immunex Corporation	ENBREL MINI	etanercept	Injection	103795	10,058,589	2032-10-26	Patent claims search

International Patents for ENBREL MINI

Country	Patent Number	Estimated Expiration
Australia	671116
Canada	2065346
Canada	2133326
Canada	2065346
Finland	20051161

Supplementary Protection Certificates for ENBREL MINI

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
00C0015	France		PRODUCT NAME: ETANERCEPT; NAT. REGISTRATION NO/DATE: EU/1/99/126/001 20000203; FIRST REGISTRATION: LI - IKS- N 55365 20000201
10075011	Germany		PRODUCT NAME: ENBREL-ETANERCEPT; NAT. REGISTRATION NO/DATE: EU/1/99/126/001 20000203; FIRST REGISTRATION: CH (LI) 55365 20000201
132000900852970	Italy
0090011-8, 0091011-7	Sweden		NATIONAL REGISTRATION NO/DATE: EU/1/99/126/001 20000203; FIRST REGISTRATION: LI 55365 20000201
SPC/GB00/015	United Kingdom		PRODUCT NAME: ETANERCEPT; REGISTERED: CH 55365 20000201; UK EU/1/99/126/001 20000203

Market Dynamics and Financial Trajectory for Enbrel Mini

Introduction to Enbrel Mini

Enbrel Mini, a newer version of the injection device for the drug Enbrel (etanercept), is a significant product in the biopharmaceutical sector, particularly for treating autoimmune diseases such as rheumatoid arthritis, psoriatic arthritis, and plaque psoriasis. Here, we delve into the market dynamics and financial trajectory of Enbrel Mini.

Market Size and Growth

The global Enbrel market, which includes Enbrel Mini, is substantial and growing. As of 2023, the Enbrel market was valued at approximately USD 16.2 billion and is projected to reach USD 23.2 billion by 2032, with a Compound Annual Growth Rate (CAGR) of 3.7% from 2023 to 2032[4].

Market Share

Enbrel, including Enbrel Mini, holds a dominant position in the etanercept market, capturing more than 34% of the market share by drug type. This dominance is due to its efficacy and established presence in treating autoimmune diseases[3].

Revenue and Profitability

Historical Revenue

Amgen, the manufacturer of Enbrel, has seen significant revenue growth from the drug. From 2003 to 2019, Enbrel's net U.S. revenue increased from $1.25 billion to over $5 billion. This growth was largely driven by price increases; for instance, the price of Enbrel increased by 457% from the date Amgen acquired the drug, resulting in a monthly price of $5,556 or $72,240 annually[1].

Recent Financial Performance

In the first quarter of 2023, Enbrel sales decreased by 33% year-over-year, primarily due to a decline in the net selling price and lower inventory levels. However, this decline was part of a broader trend where total revenues decreased by 2% compared to the first quarter of 2022[5].

Pricing Strategies and Impact

Price Increases

Amgen's pricing decisions for Enbrel, including Enbrel Mini, have been driven by revenue targets. The company has raised the price of Enbrel multiple times, with a notable 9.7% increase in January 2018. These price increases have helped maintain net revenue despite declining sales volumes and increasing rebates[1].

Revenue Targets

Internal communications reveal that Amgen executives, such as Executive Vice President Anthony Hooper, focused on meeting aggressive revenue targets through price adjustments. For example, in 2017, Amgen increased the price of Sensipar (another Amgen drug) by 8% to avoid a $58 million loss in net revenue[1].

Market Trends and Drivers

Personalized Medicine

The trend towards personalized medicine is a significant driver for the Enbrel market. Tailored treatment plans optimize patient outcomes and reduce adverse effects, attracting more patients and healthcare providers[4].

Digital Health and Telemedicine

The integration of telemedicine and digital health tools has expanded patient access, improved patient engagement, and enhanced medication adherence. This trend is particularly beneficial for Enbrel Mini, as it facilitates remote monitoring and treatment management[4].

Global Expansion

There are growth opportunities in expanding Enbrel’s availability in emerging markets with unmet medical needs. Exploring new indications and potential combination therapies further diversifies its applications and patient base[4].

Challenges and Threats

Biosimilar Competition

The increasing availability of biosimilar alternatives to Enbrel poses a significant threat. Biosimilars enhance affordability and competition, potentially reducing Enbrel’s market share[4].

Regulatory and Economic Factors

Efforts to control healthcare costs, including drug pricing, by governments and payers can impact the affordability and accessibility of Enbrel. Economic downturns or changes in healthcare reimbursement policies can also affect demand[4].

Adverse Events and Safety Concerns

Any safety issues or adverse events associated with Enbrel can significantly impact its market reputation and demand. This is a critical factor that Amgen must continuously monitor and address[4].

Regional Dynamics

North America

In North America, Enbrel faces strong demand due to a high prevalence of autoimmune diseases. The region also sees growing biosimilar competition and an emphasis on personalized medicine. The adoption of digital health tools and telemedicine is rising, improving patient access and engagement[4].

Europe

The European market is mature with substantial biosimilar competition, pushing for affordability. There is an increasing focus on early-stage biologic treatments, personalized medicine, and regulatory changes affecting pricing and access[4].

Asia-Pacific

The Asia-Pacific region has shown significant growth, with a 47% volume growth in the first quarter of 2023. This region presents opportunities for market expansion due to unmet medical needs and the growing adoption of biologic treatments[5].

Key Takeaways

• Market Growth: The Enbrel market, including Enbrel Mini, is expected to grow at a CAGR of 3.7% from 2023 to 2032.
• Revenue: Enbrel’s revenue has been driven by price increases, but recent sales have declined due to lower net selling prices and inventory levels.
• Pricing Strategies: Amgen’s pricing decisions are driven by revenue targets, which have helped maintain net revenue despite declining sales volumes.
• Market Trends: Personalized medicine, digital health, and global expansion are key drivers, while biosimilar competition and regulatory factors pose significant challenges.
• Regional Dynamics: North America, Europe, and the Asia-Pacific region each present unique opportunities and challenges for Enbrel Mini.

FAQs

1. What is the current market size of the Enbrel market?

The global Enbrel market was valued at approximately USD 16.2 billion in 2023[4].

2. How is the Enbrel market expected to grow?

The Enbrel market is expected to reach USD 23.2 billion by 2032, with a CAGR of 3.7% from 2023 to 2032[4].

3. What are the main drivers for the Enbrel market?

Key drivers include personalized medicine, digital health and telemedicine, and global expansion into emerging markets[4].

4. What challenges does Enbrel face in the market?

Enbrel faces challenges from biosimilar competition, regulatory and economic factors, and potential adverse events or safety concerns[4].

5. How has the pricing strategy of Enbrel impacted its revenue?

Price increases have been a significant factor in maintaining Enbrel’s net revenue, despite declining sales volumes and increasing rebates[1].

Cited Sources

1. Oversight Democrats House Report: "Drug Pricing Investigation" - Internal strategy documents indicate that Amgen used minor changes to Enbrel's design to maintain high prices[1].
2. Amgen Press Release: "AMGEN REPORTS FOURTH QUARTER AND FULL YEAR 2021 FINANCIAL RESULTS" - Details on Amgen's financial performance and revenue[2].
3. Market Research Biz Report: "Etanercept Market Size, Share, Growth | CAGR of 4.5%" - Market size and growth projections for the etanercept market[3].
4. Custom Market Insights Report: "Global Enbrel Market Size, Trends, Share, Forecast 2032" - Detailed market analysis and growth factors for the Enbrel market[4].
5. PR Newswire: "AMGEN REPORTS FIRST QUARTER FINANCIAL RESULTS" - Recent financial performance and trends for Enbrel sales[5].