VASCEPA Drug Patent Profile

When do Vascepa patents expire, and what generic alternatives are available?

Vascepa is a drug marketed by Amarin Pharms and is included in one NDA. There are sixty-four patents protecting this drug and two Paragraph IV challenges.

This drug has three hundred and eighty-four patent family members in forty-six countries.

The generic ingredient in VASCEPA is icosapent ethyl. There are twelve drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the icosapent ethyl profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Vascepa

A generic version of VASCEPA was approved as icosapent ethyl by HIKMA on May 21^st, 2020.

Summary for VASCEPA

International Patents:	384
US Patents:	64
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	60
Clinical Trials:	16
Patent Applications:	950
Drug Prices:	Drug price information for VASCEPA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VASCEPA
What excipients (inactive ingredients) are in VASCEPA?	VASCEPA excipients list
DailyMed Link:	VASCEPA at DailyMed

See drug prices for VASCEPA

Recent Clinical Trials for VASCEPA

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
National Cancer Institute (NCI)	Phase 1/Phase 2
Unity Health Toronto	Phase 4
Canadian Medical and Surgical Knowledge Translation Research Group	Phase 4

See all VASCEPA clinical trials

Paragraph IV (Patent) Challenges for VASCEPA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
VASCEPA	Capsules	icosapent ethyl	500 mg	202057	1	2017-08-29
VASCEPA	Capsules	icosapent ethyl	1 g	202057	4	2016-07-26

US Patents and Regulatory Information for VASCEPA

VASCEPA is protected by sixty-nine US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Amarin Pharms	VASCEPA	icosapent ethyl	CAPSULE;ORAL	202057-001	Jul 26, 2012	AB	RX	Yes	Yes	8,440,650
Amarin Pharms	VASCEPA	icosapent ethyl	CAPSULE;ORAL	202057-001	Jul 26, 2012	AB	RX	Yes	Yes	10,278,935
Amarin Pharms	VASCEPA	icosapent ethyl	CAPSULE;ORAL	202057-002	Feb 16, 2017	AB	RX	Yes	No	8,617,594
Amarin Pharms	VASCEPA	icosapent ethyl	CAPSULE;ORAL	202057-002	Feb 16, 2017	AB	RX	Yes	No	10,278,937

Expired US Patents for VASCEPA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Amarin Pharms	VASCEPA	icosapent ethyl	CAPSULE;ORAL	202057-001	Jul 26, 2012	8,188,146
Amarin Pharms	VASCEPA	icosapent ethyl	CAPSULE;ORAL	202057-002	Feb 16, 2017	8,188,146

EU/EMA Drug Approvals for VASCEPA

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Amarin Pharmaceuticals Ireland Limited	Vazkepa	icosapent ethyl	EMEA/H/C/005398 Indicated to reduce cardiovascular risk as an adjunct to statin therapy.	Authorised	no	no	no	2021-03-26

International Patents for VASCEPA

See the table below for patents covering VASCEPA around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	2023226708	Methods of reducing the risk of cardiovascular events in a subject
Canada	3160827	METHODE DE REDUCTION DU RISQUE D'EVENEMENTS CARDIOVASCULAIRES CHEZ UN SUJET (METHODS OF REDUCING THE RISK OF CARDIOVASCULAR EVENTS IN A SUBJECT)
Japan	5134916
Mexico	2022009942	COMPOSICIONES FARMACEUTICAS QUE COMPRENDEN EPA Y UN AGENTE CARDIOVASCULAR Y METODOS PARA UTILIZAR EL MISMO. (PHARMACEUTICAL COMPOSITIONS COMPRISING EPA AND A CARDIOVASCULAR AGENT AND METHODS OF USING THE SAME.)

Supplementary Protection Certificates for VASCEPA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2022495	122021000058	Germany		PRODUCT NAME: ICOSAPENT-ETHYL; REGISTRATION NO/DATE: EU/1/20/1524 20210326
2443246	21C1046	France		PRODUCT NAME: ICOSAPENT ETHYL; NAT. REGISTRATION NO/DATE: EU/1/20/1524 20210329; FIRST REGISTRATION: - EU/1/20/1524 20210329
0253738	96C0009	Belgium		PRODUCT NAME: CONCENTRE A 85 % D'OMEGA POLYINSATURES; QUANTITE CORRESPONDANT A :; ESTERS ETHYLIQUES D'ACIDE EICOSAPENTAENOIQUE (EPA) ET D'ACIDE DOCOSAHEXAENOIQUE (DHA); ALPHA TOCOPHEROL; NAT. REGISTRATION NO/DATE: NL 20819 19951002; FIRST REGISTRATION:
2443246	CR 2021 00036	Denmark		PRODUCT NAME: ICOSAPENT ETHYL; REG. NO/DATE: EU/1/20/1524 20210329

Market Dynamics and Financial Trajectory for VASCEPA

Introduction

VASCEPA, a highly purified eicosapentaenoic acid (EPA) drug developed by Amarin, has been a significant player in the omega-3 prescription drugs market. Here, we delve into the current market dynamics and the financial trajectory of VASCEPA, especially in the context of generic competition and global expansion.

Market Position of VASCEPA

VASCEPA holds a dominant position in the omega-3 prescription drugs market, anticipated to capture around 47.7% of the market share during the forecast period. This dominance is largely due to its FDA approval and established preference for reducing cardiovascular risks among patients with high triglyceride levels[4].

Impact of Generic Competition in the U.S.

The launch of generic versions of icosapent ethyl in the United States has significantly impacted VASCEPA's revenue. Generic companies typically do not invest in market education or expansion, and the manufacturing of icosapent ethyl is challenging and expensive, leading to limited supply capacity and lower gross margins for generics. Despite this, Amarin has seen a decline in U.S. net product revenue, primarily due to a drop in the net selling price and the loss of exclusive commercial accounts[1][2][5].

Financial Performance

In the second quarter of 2024, Amarin reported a total net revenue of $67.5 million, a 16% decrease year-over-year. The U.S. net product revenue declined by 32% due to generic competition. The company's gross margin on net product revenue decreased to 48% from 64% in the same period of 2023. However, Amarin maintained a strong cash position of $307 million, providing financial stability[2].

In the third quarter of 2024, total net revenue further decreased to $42.3 million, down 36% from the corresponding period in 2023. This decline was driven by the impact of generic competition on the net selling price and a decrease in volume, particularly due to CVS no longer covering VASCEPA as an exclusive product[5].

Global Expansion and Regulatory Approvals

Despite the challenges in the U.S. market, Amarin is focusing on global expansion to offset revenue declines. The company has received regulatory approval for VASCEPA in China for cardiovascular risk reduction and secured national reimbursement for VAZKEPA in Portugal and Greece. These developments are crucial for Amarin's future growth trajectory[2][3].

Strategic Adjustments

Amarin is adjusting its approach to accommodate changes in market dynamics. The company continues robust sales and marketing efforts to maintain VASCEPA as a prioritized area of focus and a significant source of revenue. Amarin also explores ways to increase awareness and education about VASCEPA, particularly in the context of COVID-19 restrictions[1].

Leadership and Operational Efficiency

The company has completed a leadership transition with Aaron Berg appointed as President and CEO. Amarin has also realized significant annual savings of $50 million from its 2023 restructuring efforts, which has helped in maintaining operational efficiency[2].

Clinical Research and Market Education

Amarin continues to invest in clinical research, such as pilot studies exploring VASCEPA's potential in improving patient care during the COVID-19 pandemic. New research presented at the 60th Annual European Association for the Study of Diabetes (EASD) Meeting highlights the clinical impact of VASCEPA/VAZKEPA in patients with diabetes and high cardiovascular risk[5].

Distribution Channels and Market Dynamics

The retail pharmacy segment is expected to hold more than 52.3% of the omega-3 prescription drugs market share by 2037, driven by increasing convenience and accessibility. This trend, along with the adoption of e-prescriptions and telehealth services, is likely to drive sales of omega-3 prescription drugs, including VASCEPA, in retail settings[4].

Key Takeaways

• Generic Competition: The launch of generic icosapent ethyl in the U.S. has impacted VASCEPA's revenue, but Amarin's robust marketing efforts and limited generic supply capacity help maintain market presence.
• Global Expansion: Regulatory approvals in China, Portugal, and Greece are key to offsetting U.S. revenue declines.
• Financial Stability: Amarin maintains a strong cash position despite revenue declines.
• Operational Efficiency: Restructuring efforts have resulted in significant annual savings.
• Clinical Research: Ongoing research highlights VASCEPA's clinical benefits, supporting its market position.

FAQs

What is the impact of generic competition on VASCEPA's revenue in the U.S.?

The launch of generic icosapent ethyl in the U.S. has led to a decline in VASCEPA's revenue, primarily due to a drop in the net selling price and the loss of exclusive commercial accounts.

How is Amarin addressing the challenges posed by generic competition?

Amarin continues robust sales and marketing efforts to maintain VASCEPA as a prioritized area of focus. The company also focuses on global expansion and clinical research to support its market position.

What are the key global markets for VASCEPA's expansion?

Amarin is focusing on expansion in China, Europe, Portugal, and Greece, where regulatory approvals and national reimbursements have been secured.

How has Amarin's financial performance been affected by generic competition?

Total net revenue has declined due to generic competition, but Amarin maintains a strong cash position and has realized significant savings from restructuring efforts.

What are the future growth prospects for VASCEPA?

Amarin's future growth is expected to be driven by global expansion, particularly in China and Europe, along with ongoing clinical research and market education efforts.

Sources

1. Amarin's plan for operations now that generic versions of icosapent ethyl have launched in the United States. Amarin Corporation.
2. Amarin Reports Second Quarter 2024 Financial Results and Provides Business Update. Stock Titan.
3. Earnings call: Amarin reports Q2 2024 results, eyes global VASCEPA expansion. Investing.com.
4. Omega-3 Prescription Drugs Market Market Analysis. Research Nester.
5. Amarin Reports Third Quarter 2024 Financial Results and Provides Business Update. GlobeNewswire.