ENBREL Drug Profile

Summary for Tradename: ENBREL

High Confidence Patents:	8
Applicants:	1
BLAs:	1
Drug Prices:	Drug price information for ENBREL
Recent Clinical Trials:	See clinical trials for ENBREL
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ENBREL

See drug prices for ENBREL

Recent Clinical Trials for ENBREL

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Benaroya Research Institute	Early Phase 1
University of California, San Diego	Early Phase 1
Brooke Army Medical Center	Phase 3

See all ENBREL clinical trials

Recent Litigation for ENBREL

Identify key patents and potential future biosimilar entrants

District Court Litigation

Case Name	Date
AbbVie Inc. v. Hetero USA, Inc.	2024-08-08
AbbVie Inc. v. Hetero USA, Inc.	2023-11-20
FENNEC PHARMACEUTICALS, INC. v. CIPLA LIMITED	2023-01-10

See all ENBREL litigation

PTAB Litigation

Petitioner	Date
Dr. Reddy's Laboratories, Inc. et al.	2018-08-03
	2014-11-06
	2013-08-15

See all ENBREL litigation

Pharmacology for ENBREL

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 Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for ENBREL 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	etanercept	For Injection	103795		2036-10-21	Company disclosures
Immunex Corporation	ENBREL	etanercept	For Injection	103795			Company disclosures
Immunex Corporation	ENBREL	etanercept	For Injection	103795		2012-03-07	Company disclosures
Immunex Corporation	ENBREL	etanercept	For Injection	103795		2014-02-25	Company disclosures
Immunex Corporation	ENBREL	etanercept	For Injection	103795		2009-09-05	Company disclosures
Immunex Corporation	ENBREL	etanercept	For Injection	103795		2009-09-11	Company disclosures

3) Low Certainty: US Patents for ENBREL 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	etanercept	For Injection	103795		2034-06-16	Patent claims search
Immunex Corporation	ENBREL	etanercept	For Injection	103795		2033-03-11	Patent claims search
Immunex Corporation	ENBREL	etanercept	For Injection	103795		2033-08-13	Patent claims search
Immunex Corporation	ENBREL	etanercept	For Injection	103795		2039-02-26	Patent claims search
Immunex Corporation	ENBREL	etanercept	For Injection	103795		2032-10-26	Patent claims search
Immunex Corporation	ENBREL	etanercept	For Injection	103795		2032-07-26	Patent claims search

International Patents for ENBREL

Country	Patent Number	Estimated Expiration
Canada	2123593
Australia	630497
Canada	2133326
Germany	69024291
Spain	2080809
World Intellectual Property Organization (WIPO)	0062790

Supplementary Protection Certificates for ENBREL

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
SZ 15/2000	Austria		PRODUCT NAME: ETANERCEPT
SPC/GB00/015	United Kingdom		PRODUCT NAME: ETANERCEPT; REGISTERED: CH 55365 20000201; UK EU/1/99/126/001 20000203
C300008	Netherlands		PRODUCT: ETANERCEPTUM
15/2000	Austria		PRODUCT NAME: ETANERCEPT; NAT. REGISTRATION NO/DATE: EU/1/99/126/001 20000203; FIRST REGISTRATION: LI 55365 20000201
0090011-8, 0091011-7	Sweden		NATIONAL REGISTRATION NO/DATE: EU/1/99/126/001 20000203; FIRST REGISTRATION: LI 55365 20000201
10075011	Germany		PRODUCT NAME: ENBREL-ETANERCEPT; NAT. REGISTRATION NO/DATE: EU/1/99/126/001 20000203; FIRST REGISTRATION: CH (LI) 55365 20000201

ENBREL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for the Biologic Drug: ENBREL

Introduction to ENBREL

ENBREL, also known as etanercept, is a biologic drug developed by Amgen, used primarily to treat autoimmune diseases such as rheumatoid arthritis, psoriasis, and ankylosing spondylitis. Understanding the market dynamics and financial trajectory of ENBREL is crucial for investors, healthcare professionals, and industry analysts.

Market Size and Forecast

The ENBREL market has witnessed significant growth and is expected to continue on this upward trajectory. As of 2023, the global etanercept market, which includes ENBREL, was valued at USD 17.6 billion and is projected to reach USD 27.0 billion by 2033, growing at a Compound Annual Growth Rate (CAGR) of 4.5% during the forecast period from 2024 to 2033[4].

Market Share and Dominance

ENBREL holds a dominant position in the etanercept market, capturing more than 34% of the market share by drug type. This dominance is attributed to its efficacy and established presence in the treatment landscape for autoimmune diseases[4].

Regional Performance

The North American region is a significant market for ENBREL, accounting for a substantial share of the global etanercept market. This regional dominance is driven by high healthcare spending, an aging population, and the increasing prevalence of chronic ailments[4].

Sales Performance

In recent years, ENBREL's sales have shown mixed results. For the first quarter of 2024, ENBREL generated $567 million in sales, representing a 2% year-over-year decline primarily due to volume decreases[2]. However, in the third quarter of 2024, sales decreased more sharply by 20% year-over-year, driven by unfavorable changes to estimated sales deductions and lower net selling prices[5].

Pricing and Revenue Dynamics

The pricing strategy for ENBREL has been a critical factor in its revenue dynamics. Despite declining sales volumes, Amgen has maintained net revenue levels through significant price increases. For instance, the list price of ENBREL has increased by 457% since Amgen acquired the drug, resulting in an annual cost of $72,240 per patient[3].

Impact of Price Increases on Corporate Profits

Price increases have been a key driver of Amgen's profitability. From 2009 to 2019, Amgen reported over $57 billion in net U.S. revenue from ENBREL and another drug, Sensipar. The price increases for ENBREL have outpaced any rebates paid, allowing the company to maintain high net revenue levels despite declining sales volumes[3].

Market Drivers and Opportunities

Several factors drive the growth of the ENBREL market:

• Increasing Prevalence of Autoimmune Diseases: The rising incidence of rheumatoid arthritis, psoriasis, and other autoimmune diseases globally fuels the demand for effective treatments like ENBREL[4].
• Aging Population: An aging population increases the demand for advanced therapeutics, contributing to market growth[4].
• Advancements in Healthcare: Improvements in healthcare infrastructure and access to biologic treatments in various regions also drive market expansion[1].

Market Challenges and Restraints

Despite the positive outlook, the ENBREL market faces several challenges:

• Competition from Biosimilars: The emergence of biosimilars, such as Benepali, poses a significant competitive threat to ENBREL's market share[4].
• Regulatory Pressures: Increasing regulatory scrutiny over drug pricing and reimbursement policies can impact ENBREL's sales and profitability[3].
• Economic Factors: Economic downturns and changes in healthcare policies can affect consumer behavior and healthcare spending, potentially impacting ENBREL's market performance[1].

Financial Performance and Outlook

Amgen's financial performance is closely tied to the sales of ENBREL. Despite the recent decline in ENBREL sales, Amgen's overall financial health remains robust. For the first quarter of 2024, Amgen reported non-GAAP operating income of $3.1 billion, although this was partially offset by higher operating and interest expenses[2].

For the full year 2024, Amgen expects continued declining net selling prices for ENBREL but anticipates relatively flat volumes. This outlook suggests that while ENBREL's sales may face challenges, the company's diversified product portfolio and strategic initiatives will help mitigate these impacts[5].

Consumer Behavior and Economic Landscape

Consumer behavior and the broader economic landscape play crucial roles in the market dynamics of ENBREL. High drug prices, such as the $72,240 annual cost for ENBREL, can lead to consumer resistance and increased pressure on healthcare systems. Economic conditions, including changes in healthcare policies and reimbursement rates, also influence the market's trajectory[3].

Key Players and Competitive Dynamics

ENBREL operates in a competitive landscape dominated by a few key players. Amgen's strong market position is challenged by biosimilars and other biologic drugs. The competitive dynamics are further complicated by the entry of new players and the evolving regulatory environment[4].

Conclusion

The market dynamics and financial trajectory of ENBREL are complex and multifaceted. While the drug faces challenges such as declining sales volumes and competitive pressures, its dominant market position, driven by its efficacy and established presence, ensures continued relevance. The outlook remains positive, with projected growth driven by increasing demand for advanced therapeutics and an aging population.

Key Takeaways

• Market Growth: The global etanercept market, including ENBREL, is expected to grow at a CAGR of 4.5% from 2024 to 2033.
• Dominant Market Share: ENBREL holds a significant market share of over 34% in the etanercept market.
• Pricing Strategy: Price increases have been a critical factor in maintaining ENBREL's revenue levels despite declining sales volumes.
• Competitive Challenges: The emergence of biosimilars and regulatory pressures pose significant challenges to ENBREL's market position.
• Financial Outlook: Amgen's financial performance is expected to remain robust despite challenges in ENBREL sales.

FAQs

1. What is the projected market size of the global etanercept market by 2033? The global etanercept market is expected to reach USD 27.0 billion by 2033[4].

2. What is the current market share of ENBREL in the etanercept market? ENBREL holds a dominant market share of over 34% in the etanercept market[4].

3. How have price increases impacted ENBREL's revenue? Price increases have allowed Amgen to maintain high net revenue levels for ENBREL despite declining sales volumes[3].

4. What are the main drivers of the ENBREL market growth? The main drivers include the increasing prevalence of autoimmune diseases, an aging population, and advancements in healthcare infrastructure[4].

5. What challenges does ENBREL face in the market? ENBREL faces challenges from biosimilars, regulatory pressures, and economic factors such as changes in healthcare policies and reimbursement rates[3][4].

Sources

1. Market Research Intellect - Enbrel Sales Market Size And Forecast
2. PR Newswire - AMGEN REPORTS FIRST QUARTER 2024 FINANCIAL RESULTS
3. House Oversight Committee - Drug Pricing Investigation
4. Market Research Biz - Etanercept Market Size, Share, Growth | CAGR of 4.5%
5. Amgen - AMGEN REPORTS THIRD QUARTER 2024 FINANCIAL RESULTS