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-three patents protecting this drug and two Paragraph IV challenges.

This drug has four hundred and twenty-two 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. Eighteen 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:	422
US Patents:	63
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	67
Clinical Trials:	18
Patent Applications:	1,793
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
Ottawa Heart Institute Research Corporation	PHASE3
University of Louisville	PHASE4
National Cancer Institute (NCI)	Phase 1/Phase 2

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-eight 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	202057-002	Feb 16, 2017	AB	RX	Yes	No	8,426,399
Amarin Pharms	VASCEPA	icosapent ethyl	CAPSULE;ORAL	202057-002	Feb 16, 2017	AB	RX	Yes	No	10,555,924
Amarin Pharms	VASCEPA	icosapent ethyl	CAPSULE;ORAL	202057-001	Jul 26, 2012	AB	RX	Yes	Yes	11,369,582
Amarin Pharms	VASCEPA	icosapent ethyl	CAPSULE;ORAL	202057-001	Jul 26, 2012	AB	RX	Yes	Yes	10,265,287
Amarin Pharms	VASCEPA	icosapent ethyl	CAPSULE;ORAL	202057-002	Feb 16, 2017	AB	RX	Yes	No	8,691,871
Amarin Pharms	VASCEPA	icosapent ethyl	CAPSULE;ORAL	202057-002	Feb 16, 2017	AB	RX	Yes	No	11,717,504

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/005398Indicated 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
Spain	2846176
European Patent Office	3815684
Japan	2018184463	スタチン療法中の患者における心血管系イベントの危険性を減少させる方法 (METHODS FOR REDUCING RISK OF CARDIOVASCULAR EVENT IN PATIENT ON STATIN THERAPY)
Serbia	67161	ETIL ESTAR EIKOZAPENTAENSKE KISELINE ZA UPOTREBU U SMANJENJU RIZIKA OD NESMRTONOSNOG ŠLOGA KOD PACIJENTA NA TERAPIJI STATINIMA (EICOSAPENTAENOIC ACID ETHYL ESTER FOR USE IN REDUCING THE RISK OF NON-FATAL STROKE IN A SUBJECT ON STATIN THERAPY)
South Korea	102296068
Hong Kong	1255106

Supplementary Protection Certificates for VASCEPA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2443246	2021042	Norway		PRODUCT NAME: IKOSAPENTETYL; REG. NO/DATE: EU/1/20/1524 20210408
2443246	PA2021522,C2443246	Lithuania		PRODUCT NAME: IKOZAPENTO ETILAS; REGISTRATION NO/DATE: EU/1/20/1524 20210326
2443246	39/2021	Austria		PRODUCT NAME: ICOSAPENT-ETHYL (= EICOSAPENTAENSAEUREETHYLESTER,; REGISTRATION NO/DATE: EU/1/20/1524 20210329
2443246	LUC00226	Luxembourg		PRODUCT NAME: ICOSAPENT ETHYL; AUTHORISATION NUMBER AND DATE: EU/1/20/1524 20210329
2443246	PA2021522	Lithuania		PRODUCT NAME: IKOZAPENTO ETILAS; REGISTRATION NO/DATE: EU/1/20/1524 20210326
2022495	21C1045	France		PRODUCT NAME: ICOSAPENT ETHYL; REGISTRATION NO/DATE: EU/1/20/1524 20210329

Market Dynamics and Financial Trajectory for Vascepa

Last updated: July 27, 2025

Introduction

Vascepa (icosapent ethyl), developed by Amarin Corporation, has emerged as a pivotal drug in the cardiovascular therapeutic landscape. Originally approved for hypertriglyceridemia, Vascepa’s repositioning as a cardiovascular risk reducer has significantly altered its market trajectory. This analysis explores the complex market forces, regulatory landscape, competitive environment, and financial implications shaping Vascepa’s future.

Market Landscape and Demographic Trends

The global cardiovascular disease (CVD) market is expanding, driven by aging populations, rising prevalence of dyslipidemia, obesity, and diabetes. Epidemiological data project that CVD will remain the leading cause of death worldwide, with an estimated 17.9 million deaths annually [1]. Dyslipidemia, particularly elevated triglycerides, remains a modifiable risk factor. Vascepa’s targeted efficacy positions it as a complementary therapy to statins, especially for high-risk populations unable to tolerate or achieve lipid goals with existing therapies.

In the U.S., approximately 25% of adults have elevated triglycerides (≥150 mg/dL), with a subset exhibiting very high levels (>500 mg/dL) linked to pancreatitis risk. However, the target population for Vascepa’s broader cardiovascular indication is those with persistent residual risk despite statin therapy—estimated at several million Americans [2]. This demographic dynamic provides a sizable and growing market.

Globally, the market potential extends to Europe and Asia-Pacific regions, where CVD prevalence is surging, and lipid management protocols are increasingly aligned with evidence-based guidelines favoring novel agents like Vascepa. Regulatory acceptance varies, influencing regional market entry and expansion strategies.

Regulatory Milestones and Impact

Vascepa's market trajectory has been profoundly influenced by pivotal regulatory decisions. In 2019, the FDA approved Vascepa to reduce major cardiovascular events in high-risk adults on statin therapy, based on the REDUCE-IT trial’s compelling results [3]. This designation provided a significant value proposition and competitive edge.

However, regulatory challenges emerged in 2020 when the FDA raised concerns over Vascepa’s patent and data integrity aspects, prompting litigation and market uncertainty. Despite this, Amarin’s ongoing patent protections and robust clinical evidence secured continued approval and incentivized adoption.

European and other jurisdictions have also granted varied approvals, often with different stipulations, affecting Vascepa’s international market access. Regulatory environments that recognize and incorporate REDUCE-IT’s evidence will catalyze broader adoption.

Competitive Environment and Therapeutic Alternatives

The cardiovascular lipid management landscape is crowded, with statins being the gold standard. Several non-statin options, including fibrates, niacin, and newer agents like PCSK9 inhibitors, occupy segments of this market. Vascepa’s unique positioning as an EPA-only omega-3 fatty acid distinguishes it from over-the-counter fish oil supplements and previous multi-ingredient formulations.

More recently, Novo Nordisk’s LIVMARZI and other lipid-modulating drugs are entering the market, potentially encroaching on Vascepa’s space. Over-the-counter omega-3 supplements, lacking regulatory oversight and consistent formulation, serve as primary competitors in the consumer segment but lack robust evidence and FDA approval.

The anticipated FDA decision on generic or bioequivalent versions will influence market share and pricing strategies. Amarin’s patent estate and exclusivity rights remain central to maintaining its competitive advantage.

Pricing Strategies and Revenue Streams

Vascepa’s pricing has been a critical driver of revenue. As of 2022, the list price per month was approximately $320, reflecting a premium positioned on clinical efficacy and the cost of cardiovascular events avoided [4]. Insurance reimbursement practices, including PBMs and Medicare Part D, significantly impact patient access.

Amarin’s strategic focus has involved direct-to-consumer marketing and physician education, bolstered by positive REDUCE-IT outcomes. However, ongoing debates over the cost-effectiveness of Vascepa versus alternatives influence pricing negotiations with payers.

In response to market pressures and potential biosimilar competition, Amarin may adopt a tiered pricing model, emphasizing value-based pricing aligned with clinical outcomes. Expanding indications and broader usage could diversify revenue streams beyond hypertriglyceridemia treatment.

Financial Trajectory and Growth Prospects

Amarin’s financial performance has exhibited notable growth phases. In 2021, Vascepa sales surpassed $600 million globally, a significant increase driven by REDUCE-IT’s success and market adoption [5]. The company reported a gross margin of approximately 75%, reflective of high-margin specialty pharmaceuticals.

Future revenue growth hinges on several factors:

• Market Penetration: Expanding into international markets where cardiovascular risk management aligns with Vascepa’s evidence base.

• Regulatory Approvals: Securing additional indications, such as in primary prevention, broadens the patient base.

• Competitive Dynamics: Countering generics and alternative therapies through patent protections and demonstrating superior clinical efficacy.

• Pricing and Reimbursement: Navigating payer negotiations to sustain premium pricing amid growing competition.

Analysts project Vascepa’s global sales could reach $1.5 billion by 2025 if market expansion and regulatory milestones are achieved, representing an attractive valuation for Amarin and stakeholders [6].

Challenges and Risks

Key risks include patent litigation, regulatory hurdles, and market saturation. The recent issuance of generic formulations in the U.S. and international markets could significantly pressure prices and margins. Additionally, inconsistent interpretations of clinical data by regulatory agencies may influence approval of new indications or formulations.

Reimbursement uncertainties and the evolving landscape of lipid therapies could also restrict uptake. Furthermore, the emergence of newer, potentially more cost-effective agents may displace Vascepa in certain segments.

Conclusion

Vascepa’s market dynamics are shaped by a confluence of demographic shifts, regulatory milestones, and competitive forces. Its financial trajectory will primarily depend on successful market penetration, patent protection, and the adaptability of pricing strategies amid competitive pressures.

With robust clinical evidence supporting its cardiovascular benefits, Vascepa is well-positioned to capitalize on the rising global burden of CVD. However, proactive management of regulatory and patent challenges remains crucial for sustained growth.

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Key Takeaways

• Vascepa benefits from a substantial and growing high-risk cardiovascular patient base, especially those with residual risk despite statin therapy.

• Regulatory approvals based on the REDUCE-IT trial have significantly enhanced Vascepa’s market potential, though ongoing patent and litigation issues pose challenges.

• Competitive landscape includes traditional lipid management therapies and emerging agents; Vascepa’s EPA-only formulation provides a unique market position.

• High product pricing and reimbursement strategies are pivotal to sustaining revenue growth; market expansion into international regions offers additional upside.

• Future financial success depends on continued innovation, patent protections, and navigating regulatory and competitive uncertainties.

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FAQs

1. What is the primary mechanism by which Vascepa reduces cardiovascular risk?
Vascepa’s active ingredient, icosapent ethyl, is an ethyl ester of eicosapentaenoic acid (EPA). It primarily reduces inflammation and plasma triglycerides, which are associated with atherosclerosis. The REDUCE-IT trial demonstrated that Vascepa significantly lowers major adverse cardiovascular events in high-risk patients, likely through anti-inflammatory and plaque-stabilizing effects.

2. How does Vascepa differ from over-the-counter omega-3 supplements?
Vascepa contains a high-purity, EPA-only formulation proven through rigorous clinical trials to reduce cardiovascular events. Over-the-counter omega-3 supplements vary widely in EPA/DHA content, often lack regulatory oversight, and have not demonstrated similar clinical outcomes, making Vascepa's efficacy and safety profile more robust.

3. What are the key regulatory factors influencing Vascepa’s market?
Approval for cardiovascular risk reduction was granted by the FDA based on REDUCE-IT. Ongoing patent protections and potential biosimilar or generic entries influence pricing and market exclusivity. Regulatory decisions concerning additional indications or formulations in regions like Europe will further shape its market dynamics.

4. What are the main competitive threats facing Vascepa?
Generic formulations following patent expiry, emerging lipid-lowering drugs such as PCSK9 inhibitors, and alternative dietary supplements represent competitive threats. Market differentiation relies on demonstrated clinical efficacy, regulatory backing, and reimbursement support.

5. What future opportunities exist for Vascepa’s growth?
Expanding into primary prevention populations, gaining approvals in additional geographies, and developing new formulations or combination therapies offer growth avenues. Additionally, tailoring pricing and reimbursement strategies to enhance patient access will support sustained revenue growth.

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References
[1] World Health Organization. Cardiovascular diseases (CVDs). 2021.
[2] National Lipid Association. Dyslipidemia prevalence and management. 2022.
[3] FDA. FDA approves Vascepa to reduce cardiovascular risk. 2019.
[4] Amarin Corporation. Corporate financial filings, 2022.
[5] Amarin Corporation. 2021 Annual Report.
[6] MarketWatch. Vascepa market forecast and analyst estimates. 2022.