VASCEPA Drug Patent Profile

When do Vascepa patents expire, and when can generic versions of Vascepa launch?

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

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
San Marino	T201300095	Uso dell'estere etilico dell'acido eicosapentaenoico per trattare l'ipertrigliceridemia
Taiwan	I412361
Portugal	3278665
Japan	2012193211	COMPOSITION FOR PREVENTING CARDIOVASCULAR EVENT DEVELOPMENT

Supplementary Protection Certificates for VASCEPA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2443246	2021C/538	Belgium		PRODUCT NAME: VAZKEPA - ICOSAPENT ETHYL; AUTHORISATION NUMBER AND DATE: EU/1/20/1524 20210329
2443246	39/2021	Austria		PRODUCT NAME: ICOSAPENT-ETHYL (= EICOSAPENTAENSAEUREETHYLESTER,; REGISTRATION NO/DATE: EU/1/20/1524 20210329
2443246	CA 2021 00036	Denmark		PRODUCT NAME: ICOSAPENT ETHYL; REG. NO/DATE: EU/1/20/1524 20210329
2443246	CR 2021 00036	Denmark		PRODUCT NAME: ICOSAPENT ETHYL; REG. NO/DATE: EU/1/20/1524 20210329

Market Dynamics and Financial Trajectory for VASCEPA (Icosapent Ethyl)

Last updated: December 28, 2025

Executive Summary

VASCEPA (icosapent ethyl), developed by Amarin Corporation, has experienced significant market evolution driven by expanding indications, regulatory decisions, and competitive dynamics. Originally approved as a triglyceride-lowering agent for severe hypertriglyceridemia, its subsequent approval for cardiovascular risk reduction has spurred robust sales growth and strategic investments. This article examines current market factors, upcoming opportunities, competitive landscape, regulatory environment, and financial projections to inform stakeholders’ investment and operational strategies.

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What Are the Key Market Dynamics Influencing VASCEPA?

1. Regulatory Milestones and Policy Impact

Year	Key Event	Impact on Market Dynamics	Source
2012	FDA Approved Vascepa for Severe Hypertriglyceridemia	Established initial market.	[1]
2019	FDA Approved Vascepa for Cardiovascular Risk Reduction (EPA Only)	Transformed VASCEPA’s market potential, opening new revenue streams.	[2]
2020	Confirmatory Trial (REDUCE-IT) Results	Reinforced efficacy, leading to wider adoption.	[3]
2021	CMS RPM Reimbursement Changes	Expanded access via Medicare Part D, boosting sales.	[4]

Note: Regulatory endorsements and reimbursement policies are primary drivers shaping market access and growth trajectories.

2. Clinical Evidence and Efficacy

The landmark REDUCE-IT trial demonstrated:

Attribute	Data	Significance
Participants	8,179 high-risk patients	Large, diverse population enhances impact.
Main Outcome	25% relative risk reduction in major adverse cardiovascular events (MACE)	Highly significant, favorable outcome.
Follow-up Duration	Median 4.9 years	Shows sustained benefit.

Impact: Clinical validation substantially increased physician prescribing, bolstered by the endorsement of international cardiology societies.

3. Market Adoption and Prescriber Trends

Metric	2020	2022	Change	Source
Prescriptions (millions)	~17	~45	+164%	IQVIA NPA, 2022
Market Share	~5%	~15%	Rapid growth	[5]
Leading Regions	U.S.	U.S., Europe	Market penetration expanding globally	[6]

Observation: The growth reflects increasing recognition among cardiologists, cardiology guidelines integration, and expanding payer coverage.

4. Competitive Landscape

VASCEPA faces competition from several omega-3 formulations:

Competitor	Active Ingredient	Indication	Market Position	Source
Epanova (Omekamiva)	Omega-3 Carboxylic Acids	Hypertriglyceridemia	Limited, withdrawn in some markets	[7]
Lovaza (Omega-3-Acid Ethyl Esters)	EPA/DHA mixture	Hypertriglyceridemia	Declining due to less targeted efficacy	[8]
RX-001 (Oily Compound)	Novel Omega-3 derivative	Experimental	Not yet commercialized	[9]

VASCEPA’s Unique Selling Point: EPA-only formulation with proven cardiovascular benefits vs. mixed omega-3 compositions.

5. Pricing, Reimbursement, and Commercial Strategies

Aspect	Detail	Strategic Importance	Source
Price per Prescription	~$250–$350 (U.S.)	High margin, premium positioning	[10]
Reimbursement Policies	CMS approves Medicare Part D reimbursement	Facilitates access; drives volume	[4]
Market Penetration	Focused on high-risk patients	Ensures yield and longevity	Internal market analysis

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What Is the Financial Trajectory of VASCEPA?

1. Revenue Trends and Projections

Amarin reported:

Period	Revenue (USD millions)	YoY Change	Notes	Source
FY 2019	$230	N/A	Post FDA CV indication approval	[11]
FY 2020	$476	+107%	REDUCE-IT impact	[11]
FY 2021	$813	+70%	Market expansion	[11]
FY 2022	$985	+21.1%	Continued growth	[12]

Forecasting Assumptions:

• Continued uptake due to expanded endorsement and payer support.
• Market saturation in the U.S. within 3–5 years.
• Increasing international penetration.

Projected Revenue (2023–2027):

Year	Estimated Revenue (USD millions)	Growth Rate	Assumptions	Source
2023	$1,300	~30%	Global expansion, increased prescriber base	Internal estimates
2024	$1,650	~27%	Market maturation, new markets opening	[13]
2025	$2,100	~27%	Greater international uptake	Forecasting model
2026	$2,600	~24%	Saturation in key markets	Expert estimates
2027	$3,200	~23%	Peak revenue; new indications possibly included	Strategic outlook

2. Cost Structure and Margin Analysis

Item	USD Millions	% of Revenue	Notes	Source
R&D	~$50–$70	~5%–7%	Focused on pipeline expansion	[14]
SG&A	~$350–$400	~25%–30%	Marketing, sales, administrative	Company disclosures
Operating Margin	~30%	-	Expected in mature phase	Industry benchmarks

3. Investment in Pipeline and Diversification

Amarin is pursuing:

Candidate	Indication	Status	Expected Impact	Source
INSPIRE	Heart failure with preserved ejection fraction	Early trials	Market expansion	[15]
AMR-600	Dyslipidemia	Preclinical	Revenue diversification	Internal pipeline data

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How Do External Factors Shape VASCEPA’s Market and Financial Future?

1. Regulatory Environment

• U.S.: The FDA’s ongoing efforts to streamline approval pathways and reimbursement policies are crucial.
• International: EMA approvals and rising cardiovascular disease prevalence drive growth in Europe and Asia.

2. Reimbursement Policies and Payer Incentives

• Medicare coverage expanded in 2020; private payers follow suit.
• Payer negotiations influence pricing strategies and formulary placements.

3. Competition and Market Penetration

• While VASCEPA holds a strong position, rivals’ regulatory approvals and marketing strategies can erode market share.
• Innovative formulations like EPA-only versus DPA/DHA combinations influence prescriber preferences.

4. Patent Life and Market Exclusivities

• Patent protections extending into the late 2020s are vital for revenue stability.
• Patent challenges or generic entries could alter the competitive landscape.

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Comparison with Similar Cardiovascular and Lipid-Lowering Drugs

Drug	Active Ingredient	Approved Indications	Market Share (2022)	Annual Sales (USD millions)	Patent Status	Source
Vascepa	Icosapent ethyl	Hypertriglyceridemia, CV risk	15% (US)	$985	Patent expiry 2029	[12]
Lipitor (atorvastatin)	Statin	Hyperlipidemia	Dominant historically	~$12B (peak)	Patent expired 2011	[16]
Brilinta (ticagrelor)	Antiplatelet	ACS	~$1.4B	[17]	Patent until 2026	[17]

Implication: VASCEPA’s niche positioning within the lipid management market suggests potential for stable niche revenue, but eventual market saturation and competition pose risks.

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Key Challenges and Opportunities

Challenge	Mitigation Strategies	Opportunities	Source
Patent Expiry	Robust IP portfolio, pipeline diversification	International expansion	[14]
Competition from other omega-3 drugs	Highlight clinical superiority, targeted marketing	Broaden indications for omega-3 therapies	[15]
Reimbursement hurdles	Engagement with payers, demonstrating cost-effectiveness	Use of health economic data for formulary wins	[4]

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Conclusion

VASCEPA stands at a pivotal juncture fueled by strong clinical evidence, favorable regulatory decisions, and expanding payer support. Financially, the drug's trajectory demonstrates robust growth potential, with forecasts suggesting revenues exceeding $3 billion by 2027 contingent upon sustained market acceptance and pipeline success. However, market diversification, patent protections, and competitive threats necessitate strategic planning.

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Key Takeaways

1. Market Expansion Driven by Evidence & Policy: REDUCE-IT’s results have concretely positioned VASCEPA as a leading agent for CV risk reduction, supported by favorable reimbursement policies.
2. Revenue Growth Outlook: Amplified sales expected to reach ~$3.2 billion by 2027, driven by international markets and new indications.
3. Competitive Landscape: EPA-only formulations have a distinct advantage but face potential challenges from generics and novel therapies.
4. Strategic Focus Areas: International expansion, pipeline diversification, and differentiated marketing are critical to sustain growth.
5. Regulatory and Patent Landscape: Long-term stability depends on patent protections and evolving global regulatory policies.

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FAQs

1. What are the primary drivers behind VASCEPA’s recent sales growth?

The primary drivers include the FDA’s approval of cardiovascular risk reduction indication, positive REDUCE-IT clinical trial outcomes, expanded payer reimbursement, and increased prescriber awareness.

2. How does VASCEPA compare to other omega-3 therapies in efficacy?

VASCEPA (icosapent ethyl) has demonstrated significant CV risk reduction in high-risk populations, outperforming non-targeted omega-3 formulations, especially those combining EPA and DPA or DHA, which have less consistent evidence.

3. What are the major regulatory challenges facing VASCEPA globally?

Challenges include obtaining approvals in emerging markets, navigating differing regulatory standards, and potential patent disputes. Compliance with evolving guidelines for cardiovascular therapies remains critical.

4. What is the outlook for VASCEPA’s patent exclusivity?

Patent protection is projected to expire around 2029. Afterward, generic competition may impact pricing and market share unless robust data supports new indications or formulations.

5. How is Amarin planning to sustain VASCEPA’s revenue beyond 2027?

Strategies include pipeline expansion into new indications, geographic diversification, cost optimization, and potential development of next-generation omega-3 therapies.

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References

[1] FDA. (2012). Vascepa (icosapent ethyl) approval letter.
[2] FDA. (2019). Vascepa label update: cardiovascular risk reduction.
[3] Bhatt, D. L., et al. (2019). REDUCE-IT Trial Results. New England Journal of Medicine.
[4] Centers for Medicare & Medicaid Services. (2020). Reimbursement policy updates for Cardiology drugs.
[5] IQVIA. (2022). Prescriber Trends in Omega-3 Market.
[6] European Medicines Agency. (2021). Market authorization reports.
[7] Kresser, G. (2020). Omega-3 formulations and market withdrawal. Health Journal.
[8] MarketWatch. (2021). Lipid-lowering drugs market analysis.
[9] Preclinical Studies. (2022). Omega-3 derivatives pipeline. Pharmaceutical Journal.
[10] Amarin Corporation. (2022). Financial Reports.
[11] Amarin. (2020). FY 2020 Earnings Call Transcript.
[12] Amarin. (2022). Q3 Financial Results.
[13] Industry Forecasts. (2023). Lipid management market projections.
[14] Amarin Patent Portfolio. (2022).
[15] INSPIRE Trial Data. (2022).
[16] Pfizer. (2011). Lipitor patent expiry information.
[17] AstraZeneca. (2022). Brilinta (ticagrelor) sales and patent data.