OMEGA-3-ACID ETHYL ESTERS - Generic Drug Details

What are the generic sources for omega-3-acid ethyl esters and what is the scope of patent protection?

Omega-3-acid ethyl esters is the generic ingredient in three branded drugs marketed by Waylis Therap, Amneal Pharms, Apotex, Ascent Pharms Inc, Chartwell, Cspc-nbp Pharm, GLW, Mankind Pharma, Onesource Specialty, Puracap Pharm Llc, Sofgen Pharms, Sun Pharm, Wilshire Pharms Inc, Zydus Lifesciences, and Osmotica Pharm Us, and is included in seventeen NDAs. Additional information is available in the individual branded drug profile pages.

There are eleven drug master file entries for omega-3-acid ethyl esters. Eighteen suppliers are listed for this compound.

Summary for OMEGA-3-ACID ETHYL ESTERS

US Patents:	0
Tradenames:	3
Applicants:	15
NDAs:	17
Drug Master File Entries:	11
Finished Product Suppliers / Packagers:	18
Raw Ingredient (Bulk) Api Vendors:	4
Clinical Trials:	78
Drug Prices:	Drug price trends for OMEGA-3-ACID ETHYL ESTERS
What excipients (inactive ingredients) are in OMEGA-3-ACID ETHYL ESTERS?	OMEGA-3-ACID ETHYL ESTERS excipients list
DailyMed Link:	OMEGA-3-ACID ETHYL ESTERS at DailyMed

See drug prices for OMEGA-3-ACID ETHYL ESTERS

See drug sales revenues for OMEGA-3-ACID ETHYL ESTERS

Recent Clinical Trials for OMEGA-3-ACID ETHYL ESTERS

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

Sponsor	Phase
University of Missouri-Columbia	PHASE2
Washington University School of Medicine	PHASE2
Children's Discovery Institute	PHASE2

See all OMEGA-3-ACID ETHYL ESTERS clinical trials

Pharmacology for OMEGA-3-ACID ETHYL ESTERS

Drug Class

Omega-3 Fatty Acid

Paragraph IV (Patent) Challenges for OMEGA-3-ACID ETHYL ESTERS

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
LOVAZA	Capsules	omega-3-acid ethyl esters	1 g	021654	3	2008-11-10

US Patents and Regulatory Information for OMEGA-3-ACID ETHYL ESTERS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sofgen Pharms	OMEGA-3-ACID ETHYL ESTERS	omega-3-acid ethyl esters	CAPSULE;ORAL	211355-001	Jul 10, 2019	AB	RX	No	No
Wilshire Pharms Inc	OMEGA-3-ACID ETHYL ESTERS	omega-3-acid ethyl esters	CAPSULE;ORAL	211345-001	Dec 7, 2023	AB	RX	No	No
Onesource Specialty	OMEGA-3-ACID ETHYL ESTERS	omega-3-acid ethyl esters	CAPSULE;ORAL	203893-001	Sep 19, 2017	AB	RX	No	No

Expired US Patents for OMEGA-3-ACID ETHYL ESTERS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Waylis Therap	LOVAZA	omega-3-acid ethyl esters	CAPSULE;ORAL	021654-001	Nov 10, 2004	5,502,077
Waylis Therap	LOVAZA	omega-3-acid ethyl esters	CAPSULE;ORAL	021654-001	Nov 10, 2004	7,732,488
Waylis Therap	LOVAZA	omega-3-acid ethyl esters	CAPSULE;ORAL	021654-001	Nov 10, 2004	5,698,594

Market Dynamics and Financial Trajectory for Omega-3-Acid Ethyl Esters

Last updated: July 27, 2025

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Introduction

Omega-3-acid ethyl esters (OM3-EE) represent a critical subset of lipid-modifying agents primarily prescribed to lower triglyceride levels and reduce cardiovascular risk. Market shifts, regulatory landscapes, and scientific advancements influence its financial trajectory. Understanding these dynamics provides stakeholders with actionable insights into investment, development, and competitive positioning.

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Market Overview

Omega-3 fatty acids, particularly eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), are derived primarily from marine sources such as fish oil. The omega-3-acid ethyl esters formulation in pharmaceutical form, notably marketed under brand names like Vascepa (Amarin Pharmaceuticals), has solidified its position within lipid management therapy. The global market for omega-3-derived drugs has displayed consistent growth, driven by expanding cardiovascular disease (CVD) prevalence, aging populations, and evolving clinical guidelines.

According to Research and Markets, the global omega-3 supplement and pharmaceutical market was valued at approximately USD 4.11 billion in 2021, with a compound annual growth rate (CAGR) of about 8% expected through 2028 (1). The pharmaceutical segment, including OM3-EE, remains a significant contributor, especially in North America, Europe, and parts of Asia-Pacific.

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Market Drivers

1. Rising Cardiovascular Disease Prevalence

Cardiovascular diseases remain the leading cause of mortality worldwide, prompting increased prescription of lipid-lowering agents, notably omega-3 fatty acids. The ESC and AHA guidelines endorse omega-3 therapy for hypertriglyceridemia, bolstering demand (2).

2. Evolving Clinical Evidence

Recent large-scale trials have solidified omega-3's role. The REDUCE-IT trial, published in 2018, demonstrated a 25% relative risk reduction in major adverse cardiovascular events for high-risk patients on 4 g/day of EPA-only OM3-EE. This bolstered the drug's credibility, leading to increased prescriptions and market share (3).

3. Regulatory Approvals and Patent Landscape

Vascepa's approval by the FDA for cardiovascular risk reduction provided a significant market advantage. Patent protection and exclusivity rights further consolidated its market position, although impending patent expirations threaten future revenue streams.

4. Healthcare Cost Dynamics

As healthcare systems push for cost-effective interventions, omega-3 therapies positioned as over-the-counter (OTC) supplements versus prescription drugs influence market segmentation and revenue streams.

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Market Challenges and Constraints

1. Competition from OTC Supplements

The proliferation of non-prescription fish oil supplements, often marketed as natural health products, introduces competitive pressure, especially in consumer-driven markets.

2. Skeptical Clinical Perspectives

Some meta-analyses and recent trials question the cardiovascular benefits of omega-3s, particularly DHA-containing formulations, potentially tempering expansion prospects (4).

3. Regulatory and Reimbursement Variability

Navigating regulatory landscapes varies globally, affecting commercialization. Reimbursement policies also influence the profitability of OM3-EE formulations, particularly in emerging markets.

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Financial Trajectory

Historical Revenue Performance

Amarin’s Vascepa reported over USD 500 million in U.S. revenue in 2021, representing a significant segment of the omega-3 pharmaceutical market (5). The product's success is attributable to strong clinical data and FDA approval for cardiovascular risk reduction, allowing premium pricing compared to OTC options.

Forecasted Growth

Projections estimate global OM3-EE market revenues will grow at a CAGR of approximately 7-8% over the next five years. The growth is driven by increased adoption in hypertriglyceridemia management, expansion into secondary prevention populations, and new formulations.

Emerging Market Potential

Markets in Asia-Pacific and Latin America exhibit high growth potential due to rising CVD rates and expanding healthcare coverage. Companies positioning to address reimbursement hurdles and regulatory challenges can capitalize on these opportunities.

Patent Expiration Impact

Vascepa’s primary patent expiry is projected around 2029-2030, opening avenues for generic entrants. This could catalyze price competition, potentially reducing revenues and margins, but also expanding consumer access.

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Strategic Opportunities and Market Outlook

1. Next-Generation Formulations

Research into combined formulations with other lipid-lowering agents or novel delivery systems could temporarily boost revenues, extending product lifecycle.

2. Diversification into Over-the-Counter Markets

Expanding into OTC segments with differentiated products may foster additional revenue streams, especially as consumer demand for health supplements continues to rise.

3. Expansion through M&A and Collaborations

Strategic acquisitions of smaller biotech firms developing innovative omega-3 derivatives or adjunct therapies could enhance market positioning and foster pipeline growth.

4. Regulatory Navigation for Indication Expansion

Seeking approval for broader indications, such as prevention in low-to-moderate risk populations, will open additional revenue avenues amid evolving clinical evidence.

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Regulatory and Economic Considerations

Regulatory agencies like the FDA, EMA, and counterparts globally will heavily influence future trajectories. The emphasis on demonstrating clinical efficacy and safety, alongside cost-effectiveness, will shape reimbursement decisions. Meanwhile, the economic landscape, including rising healthcare costs and consumer interest in natural and supplement-based therapies, supports strategic positioning of OTC and prescription variants.

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Key Takeaways

• The omega-3-acid ethyl esters market exhibits significant growth potential driven by cardiovascular health needs, evidenced by robust clinical data.
• Patent protections and regulatory approvals have historically allowed companies like Amarin to sustain premium pricing and revenue streams.
• Upcoming patent expiries and rising OTC competition necessitate innovation and diversification to maintain market share.
• Expansion into emerging markets and broader indications present strategic growth opportunities.
• Companies should monitor evolving clinical evidence and regulatory developments to navigate challenges effectively.

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FAQs

Q1: What is the primary clinical benefit of omega-3-acid ethyl esters?
A1: They primarily lower triglyceride levels and have been shown to reduce cardiovascular risk in high-risk populations, especially following evidence from REDUCE-IT.

Q2: How does patent expiration affect the market trajectory of OM3-EE products?
A2: Patent expirations typically lead to generic entry, increasing competition, lowering prices, and potentially reducing revenues for original developers.

Q3: Are OTC fish oil supplements a threat to prescription omega-3 therapies?
A3: Yes, OTC supplements compete on price and consumer preference, potentially reducing prescriptions but also expanding overall market exposure.

Q4: What regulatory challenges could impact the future of omega-3-acid ethyl esters?
A4: Variable approval standards, demonstration of clinical efficacy, and reimbursement policies influence market access and profitability.

Q5: What innovation strategies could extend the market lifespan of OM3-EE products?
A5: Developing new formulations, combination therapies, expanding indications, and entering emerging markets are key strategies.

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Sources

1. Research and Markets. "Omega-3 Market Forecast," 2022.
2. American Heart Association. "Omega-3 Fatty Acids and Cardiovascular Disease," 2019.
3. Bhatt DL, et al. "REDUCE-IT Trial Results," N Engl J Med, 2019.
4. Hooper L, et al. "Meta-Analysis of Omega-3 Fatty Acids and Heart Disease," JAMA, 2021.
5. Amarin Corporation Financial Reports, 2021.

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This analysis aims to provide a comprehensive view of the current and future market landscape for omega-3-acid ethyl esters, equipping decision-makers with insights to navigate the evolving pharmaceutical environment.