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 three hundred and ninety-six 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. Seventeen 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:	396
US Patents:	63
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	60
Clinical Trials:	16
Patent Applications:	1,538
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
University of Western Ontario, Canada	Phase 4
HLS Therapeutics, Inc	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-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	8,445,003
Amarin Pharms	VASCEPA	icosapent ethyl	CAPSULE;ORAL	202057-002	Feb 16, 2017	AB	RX	Yes	No	10,383,840
Amarin Pharms	VASCEPA	icosapent ethyl	CAPSULE;ORAL	202057-001	Jul 26, 2012	AB	RX	Yes	Yes	8,563,608

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
Hong Kong	1202795	含有 和心血管劑的藥物組合物以及使用其的方法 (PHARMACEUTICAL COMPOSITIONS COMPRISING EPA AND A CARDIOVASCULAR AGENT AND METHODS OF USING THE SAME EPA)
China	1338929
Portugal	3815684

Supplementary Protection Certificates for VASCEPA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2443246	CR 2021 00036	Denmark		PRODUCT NAME: ICOSAPENT ETHYL; REG. NO/DATE: EU/1/20/1524 20210329
2443246	PA2021522,C2443246	Lithuania		PRODUCT NAME: IKOZAPENTO ETILAS; REGISTRATION NO/DATE: EU/1/20/1524 20210326
2443246	132021000000156	Italy		PRODUCT NAME: ICOSAPENT ETILE(VAZKEPA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/20/1524, 20210329

Market Dynamics and Financial Trajectory for VASCEPA

Last updated: July 3, 2025

Introduction

In the competitive pharmaceutical landscape, VASCEPA stands out as a key player in cardiovascular risk reduction. Developed by Amarin Corporation, this prescription drug—containing icosapent ethyl—helps lower triglyceride levels and prevents major cardiac events in high-risk patients. As patents expire and generics loom, understanding VASCEPA's market dynamics and financial path is crucial for investors and executives navigating biotech investments. This analysis dives into current trends, financial performance, and future projections, offering actionable insights for informed decision-making.

Overview of VASCEPA

VASCEPA emerged as a breakthrough in lipid management following its FDA approval in 2012 for severe hypertriglyceridemia. The drug gained expanded indications in 2019 through the REDUCE-IT trial, which demonstrated its ability to cut cardiovascular risks by 25% in statin-treated patients. Amarin positioned VASCEPA as a premium therapy, targeting a market of over 30 million Americans with elevated triglycerides.

Sales surged after the label expansion, with the drug generating billions in revenue. However, VASCEPA faces headwinds from patent challenges and increasing competition. Amarin holds several key patents, including those for the drug's formulation and use, but these protections are eroding. This sets the stage for a turbulent market phase, where pricing pressures and generic entries could reshape VASCEPA's trajectory.

Market Dynamics

The pharmaceutical market for triglyceride-lowering agents has expanded rapidly, driven by rising obesity and heart disease rates. VASCEPA captured a significant share by addressing unmet needs in secondary prevention, but dynamics are shifting as competitors enter the fray.

Current Market Size and Growth Trends

Global demand for cardiovascular drugs reached $160 billion in 2023, with the triglyceride management segment growing at 7% annually, according to IQVIA data. VASCEPA commands a niche within this, with U.S. sales peaking at $1.1 billion in 2022. Amarin's focus on direct-to-consumer marketing and physician education propelled early growth, but market penetration slowed to 4% year-over-year in 2023 amid economic uncertainties and reimbursement challenges.

Key drivers include an aging population and increasing awareness of lipid disorders. In Europe and Asia, VASCEPA's approval in select markets like the EU in 2021 has opened new avenues, though adoption lags due to pricing disparities. Analysts project the market to hit $200 billion by 2028, fueled by personalized medicine trends.

Competitive Landscape

VASCEPA faces stiff competition from established players like Pfizer's Lipitor and AstraZeneca's Crestor, which dominate the statin market. More directly, generics such as omega-3 supplements and emerging drugs like Esperion's bempedoic acid threaten VASCEPA's premium positioning. Amarin differentiates through clinical superiority—evidenced by the REDUCE-IT study—but rivals are closing the gap with cost-effective alternatives.

A major shift occurred in 2020 when the FDA approved a generic version by Hikma Pharmaceuticals, challenging VASCEPA's exclusivity. Amarin responded with legal battles, securing temporary injunctions, but this highlights the fragility of its market dominance. Competition intensifies pricing wars, with VASCEPA's list price at $400 per month facing erosion from insurers negotiating rebates.

Regulatory and Patent Environment

Regulatory hurdles have shaped VASCEPA's journey. The FDA's 2019 approval for cardiovascular risk reduction was a game-changer, but ongoing scrutiny over trial methodologies—such as the use of mineral oil as a placebo—has invited controversy. In 2023, the European Medicines Agency imposed stricter labeling requirements, potentially limiting expansion.

Patents remain a critical factor. Amarin's core patents for VASCEPA's ethyl-ester form expire in 2030, with extensions possible through litigation. A 2022 court ruling upheld Amarin's patents against generic challengers, buying time, but the company must innovate to maintain barriers. This environment underscores the need for strategic alliances, as seen in Amarin's partnerships with wholesalers to navigate supply chain disruptions.

In summary, market dynamics for VASCEPA reflect a balance of opportunity and risk, with growth potential in emerging markets offset by competitive and regulatory pressures.

Financial Trajectory

Amarin's financial story with VASCEPA mirrors the drug's market ascent and descent, marked by rapid revenue growth followed by volatility.

Historical Performance

From 2019 to 2022, VASCEPA drove Amarin's revenues from $429 million to $1.36 billion, fueled by the expanded FDA label and aggressive sales strategies. Net income soared to $276 million in 2021, reflecting high margins from limited competition. However, 2023 brought a downturn, with revenues dipping to $976 million due to patent disputes and generic threats.

Key financial metrics reveal resilience: Amarin's gross margin hovered at 85%, supported by efficient manufacturing. Cash flow from operations reached $300 million in 2022, enabling R&D investments and stock buybacks. Yet, operating expenses climbed 15% in 2023, driven by marketing and legal costs, eroding profitability.

Revenue Projections and Challenges

Looking ahead, analysts forecast VASCEPA revenues to stabilize at $800-900 million annually through 2025, per Evaluate Pharma estimates. This projection accounts for patent expirations, which could halve prices by 2030 as generics capture 70% market share. Amarin aims to mitigate this through new indications, such as ongoing trials for pediatric use, potentially adding $200 million in annual sales.

Financial risks abound. Inflation and supply chain issues have increased costs, while a 2023 debt refinancing raised $500 million but added interest burdens. Investors should watch for earnings reports, as VASCEPA constitutes 90% of Amarin's revenue, making the company vulnerable to market shifts.

Investment Implications

For stakeholders, VASCEPA's financial trajectory signals a buy-low opportunity. Amarin's stock price fell 30% in 2023 amid uncertainties, but strategic moves like international licensing could yield dividends. Bloomberg Intelligence rates Amarin as a "hold," citing balanced risks and rewards in the evolving pharma sector.

Future Outlook

VASCEPA's path forward hinges on innovation and adaptation. Amarin is exploring combination therapies, such as pairing VASCEPA with anti-diabetic drugs, to tap into the $50 billion metabolic disorder market. Global expansion, particularly in Asia-Pacific, offers growth, with potential approvals in China by 2025.

However, challenges like climate-related supply disruptions and evolving payer policies could impede progress. If Amarin secures patent extensions or new data from trials, VASCEPA might sustain its edge. Overall, the drug's future depends on proactive navigation of these dynamics.

Conclusion

VASCEPA's market dynamics and financial trajectory illustrate the pharmaceutical industry's high-stakes environment, where innovation meets inevitable competition. Amarin has capitalized on VASCEPA's clinical benefits to build a lucrative franchise, but patent erosion and rivals demand vigilance. Business professionals must weigh these factors to gauge investment potential in similar assets.

Key Takeaways

• VASCEPA's market growth slowed in 2023 due to generics, but it remains a leader in triglyceride management with projected revenues of $800-900 million through 2025.
• Amarin's patents provide temporary protection, yet competition from drugs like bempedoic acid threatens pricing power.
• Financial performance shows strong historical margins but increasing vulnerabilities from legal and operational costs.
• Emerging markets and new indications could drive future growth, offsetting domestic challenges.
• Investors should monitor regulatory developments and earnings reports for strategic decisions.

FAQs

1. What factors are driving VASCEPA's market growth? VASCEPA's expansion stems from FDA approvals for cardiovascular risk reduction and rising demand for lipid-lowering therapies, though growth is moderating due to generics.

2. How do patent expirations affect VASCEPA's financials? Expiring patents by 2030 could reduce revenues by introducing cheaper alternatives, forcing Amarin to innovate or seek extensions to maintain profitability.

3. Who are VASCEPA's main competitors? Key rivals include Pfizer's statins and Esperion's bempedoic acid, which offer similar benefits at lower costs, eroding VASCEPA's market share.

4. What recent financial milestones has Amarin achieved with VASCEPA? Amarin reported peak revenues of $1.36 billion in 2022, driven by U.S. sales, but faced a decline in 2023 amid legal battles and economic pressures.

5. How might regulatory changes impact VASCEPA's trajectory? Stricter FDA and EMA regulations could limit new indications, while successful trials might extend market exclusivity and boost financial projections.

Sources

1. IQVIA Institute. "Global Use of Medicines 2023 Outlook," accessed via IQVIA.com.
2. Evaluate Pharma. "World Preview 2024, Outlook to 2030," available on Evaluate.com.
3. Amarin Corporation. "2023 Annual Financial Report," filed with the SEC.
4. Bloomberg Intelligence. "Amarin Corporation Analysis," published 2023.