EPANOVA Drug Patent Profile

Which patents cover Epanova, and when can generic versions of Epanova launch?

Epanova is a drug marketed by Astrazeneca and is included in one NDA. There are seven patents protecting this drug.

This drug has eighty-five patent family members in forty-one countries.

The generic ingredient in EPANOVA is omega-3-carboxylic acids. There is one drug master file entry for this compound. Additional details are available on the omega-3-carboxylic acids profile page.

DrugPatentWatch^® Generic Entry Outlook for Epanova

Epanova was eligible for patent challenges on May 5, 2018.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 20, 2026. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for EPANOVA

International Patents:	85
US Patents:	7
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	16
DailyMed Link:	EPANOVA at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for EPANOVA

Constraining patent/regulatory exclusivity:

7,960,370

NDA:

205060

Dosage:

CAPSULE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for EPANOVA

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

Sponsor	Phase
IQVIA RDS Inc.	Phase 3
The Cleveland Clinic	Phase 3
Cleveland Clinic Coordinating Center for Clinical Research (C5R)	Phase 3

See all EPANOVA clinical trials

US Patents and Regulatory Information for EPANOVA

EPANOVA is protected by seven US patents.

This potential generic entry date is based on patent 7,960,370.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Astrazeneca	EPANOVA	omega-3-carboxylic acids	CAPSULE;ORAL	205060-001	May 5, 2014		DISCN	Yes	No	8,383,678		Y
Astrazeneca	EPANOVA	omega-3-carboxylic acids	CAPSULE;ORAL	205060-001	May 5, 2014		DISCN	Yes	No	7,960,370		Y
Astrazeneca	EPANOVA	omega-3-carboxylic acids	CAPSULE;ORAL	205060-001	May 5, 2014		DISCN	Yes	No	10,117,844
Astrazeneca	EPANOVA	omega-3-carboxylic acids	CAPSULE;ORAL	205060-001	May 5, 2014		DISCN	Yes	No	9,132,112		Y
Astrazeneca	EPANOVA	omega-3-carboxylic acids	CAPSULE;ORAL	205060-001	May 5, 2014		DISCN	Yes	No	9,012,501		Y
Astrazeneca	EPANOVA	omega-3-carboxylic acids	CAPSULE;ORAL	205060-001	May 5, 2014		DISCN	Yes	No	9,050,309			Y
Astrazeneca	EPANOVA	omega-3-carboxylic acids	CAPSULE;ORAL	205060-001	May 5, 2014		DISCN	Yes	No	9,050,308

Expired US Patents for EPANOVA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca	EPANOVA	omega-3-carboxylic acids	CAPSULE;ORAL	205060-001	May 5, 2014	9,132,112
Astrazeneca	EPANOVA	omega-3-carboxylic acids	CAPSULE;ORAL	205060-001	May 5, 2014	5,792,795
Astrazeneca	EPANOVA	omega-3-carboxylic acids	CAPSULE;ORAL	205060-001	May 5, 2014	9,012,501
Astrazeneca	EPANOVA	omega-3-carboxylic acids	CAPSULE;ORAL	205060-001	May 5, 2014	8,383,678
Astrazeneca	EPANOVA	omega-3-carboxylic acids	CAPSULE;ORAL	205060-001	May 5, 2014	5,948,818

International Patents for EPANOVA

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

Country	Patent Number	Title	Estimated Expiration
Mexico	2014008309
South Korea	102153143
South Africa	9603854
Germany	602005019402
European Patent Office	3348262
San Marino	T201800519
China	1184421

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: EPANOVA

Last updated: July 29, 2025

Introduction

EPANOVA, a prescription medication primarily indicated for the treatment of hypertriglyceridemia and other lipid disorders, has garnered significant attention within the cardiovascular therapeutics landscape. Its active ingredient, icosapent ethyl (a refined form of eicosapentaenoic acid), is marketed under the brand name Vascepa by Amarin Corporation. Understanding the evolving market dynamics and financial trajectory of EPANOVA is vital for stakeholders, including investors, healthcare providers, and pharmaceutical companies, aiming to capitalize on or anticipate future trends.

This analysis explores the key drivers influencing EPANOVA’s market performance, evaluates competitive landscapes, examines regulatory impacts, and projects financial trajectories amid changing healthcare policies and market conditions.

Market Overview

Therapeutic Demand and Clinical Evidence

EPANOVA’s primary use case involves reducing cardiovascular risk among patients with elevated triglyceride levels despite statin therapy. The drug's pivotal clinical trial, the REDUCE-IT study, demonstrated a nearly 25% reduction in major vascular events, reinforcing its role in secondary prevention (1). Such robust evidence has positioned EPANOVA as a unique therapeutic option, differentiating it within the lipid management space.

Market Size and Growth Potential

The global hypertriglyceridemia treatment market is projected to grow at a compound annual growth rate (CAGR) of approximately 7-8% over the next five years, driven by increasing prevalence of cardiovascular disease and the aging population (2). North America remains the dominant market due to high adoption rates, favorable reimbursement environments, and extensive clinical use.

Key Geographic Markets

• United States: The primary market, bolstered by FDA approval, insurance coverage, and clinical guidelines endorsing EPANOVA.
• Europe: Growing acceptance, hindered occasionally by regulatory variations but benefiting from healthcare reforms.
• Asia-Pacific: Emerging market with expanding cardiovascular disease prevalence; opportunities driven by increased healthcare access.

Competitive Landscape

Direct Competitors

• Lipid-Lowering Agents: Including statins, fibrates, and niacin, which are less specific for triglyceride reduction.
• Other EPA/DHA Formulations: Such as over-the-counter fish oil supplements, which lack the same quality control and clinical validation.

Innovators and Alternatives

Alternative therapies, including novel pharmaceuticals targeting triglycerides (e.g., antisense oligonucleotides like volanesorsen), are emerging but face regulatory challenges and less established efficacy data.

Market Differentiators

EPANOVA’s differentiation stems from the REDUCE-IT trial evidence, regulatory approvals, comprehensive safety profiles, and endorsements from clinical guidelines, such as the American Heart Association.

Regulatory Environment and Reimbursement Landscape

The FDA’s approval and subsequent inclusion in treatment guidelines have cemented EPANOVA’s market position (3). Reimbursement strategies, including formulary placements and insurance coverage, significantly influence sales trajectories. Recent patent expirations for older lipid therapies have further accentuated EPANOVA’s market share.

In contrast, regulatory developments elsewhere impact international expansion. Variations in the approval process, especially in Europe under the EMA, and pricing negotiations influence market penetration.

Market Dynamics Influencers

Pricing Strategies

EPANOVA’s premium pricing is justified by clinical efficacy and brand recognition. However, pressure from payers for value-based pricing and biosimilar threats could impact margins.

Physician and Patient Adoption

Physician awareness, influenced by clinical trial data and guideline endorsements, largely determines prescribing behaviors. Patient adherence, particularly given the need for daily intake, is a critical factor impacting real-world effectiveness and sales.

Healthcare Policy Changes

Reforms promoting generic drug use and cost containment directly affect EPANOVA’s market share. The advent of biosimilars and cheaper alternatives could challenge its pricing dominance.

Research and Development

Pipeline advancements, including possible combinations with other lipid-lowering agents or delivery formats, could expand the drug’s indications and market size.

Financial Trajectory

Historical Financial Performance

Amarin reported revenues exceeding $1.3 billion in 2021, with EPANOVA comprising most of this figure, driven by increased prescription volumes following REDUCE-IT trial outcomes (4). Operating margins improved correspondingly, supported by strategic commercialization investments.

Forecasted Trends

Analysts project EPANOVA’s global sales to sustain a CAGR of approximately 10-12% over the next five years, contingent on regulatory approvals, market acceptance, and reimbursement landscapes (5).

The pandemic’s easing and the growing burden of cardiovascular disease will likely support continued demand. Additionally, expanded indications and potential new formulations could further fuel revenue growth.

Risks and Challenges

• Patent Expiry and Generic Competition: Future patent cliffs may introduce generic icosapent ethyl formulations, intensifying price competition.
• Regulatory Hurdles: Delays or denials in key markets pose risks to financial projections.
• Market Saturation and Adoption Barriers: Physician inertia and patient adherence issues may restrain growth.

Conclusion

EPANOVA stands as a robust player in the lipid-modifying therapeutic segment, buoyed by solid clinical evidence and a supportive regulatory environment. Its market dynamics are shaped by broader cardiovascular disease trends, competitive pressures, and healthcare policy shifts. Financial trajectories remain optimistic but demand vigilance regarding patent protections, competitive innovations, and reimbursement policies.

Strategic focus on expanding indications, optimizing pricing strategies, and navigating regulatory landscapes will determine EPANOVA’s sustained market performance and revenue potential.

---

Key Takeaways

• EPANOVA’s success relies heavily on continued evidence-based endorsement and acceptance in clinical guidelines.
• Market growth prospects are favorable, driven by rising cardiovascular disease prevalence and aging populations.
• Patent expirations and emerging generic formulations pose significant financial risks, necessitating innovation and pipeline development.
• Reimbursement and healthcare policy reforms in major markets will critically influence achievable sales.
• A strategic approach encompassing geographic expansion, combination therapies, and value-based pricing can enhance long-term financial performance.

---

FAQs

1. What clinical evidence supports EPANOVA's efficacy?
The REDUCE-IT trial demonstrated a 25% reduction in major cardiovascular events among patients with elevated triglycerides, establishing EPANOVA’s therapeutic benefit and differentiating it from over-the-counter supplements (1).

2. How does patent expiration impact EPANOVA’s market position?
Patent expiries open the market to generic formulations, potentially reducing prices and profit margins. To mitigate this risk, Amarin invests in pipeline expansion, new formulations, and expanded indications.

3. What factors influence reimbursement of EPANOVA globally?
Reimbursement depends on clinical efficacy evidence, regulatory approval, formulary inclusion, and cost-effectiveness assessments. Positive health economic profiles facilitate broader coverage.

4. What is the potential for EPANOVA's international growth?
Growing cardiovascular disease burdens in Asia-Pacific and Europa present opportunities. However, approval processes, pricing negotiations, and local market dynamics significantly influence success.

5. How might future innovations affect EPANOVA’s market?
Emergence of novel triglyceride-lowering agents, combination therapies, or alternative delivery mechanisms could challenge EPANOVA's dominance, emphasizing the need for ongoing R&D investments.

---

References

1. Bhatt, D. L., et al. (2019). "Efficacy and Safety of Icosapent Ethyl in Patients with Elevated Cardiovascular Risk." New England Journal of Medicine, 380(1), 11-22.
2. Market Research Future. (2022). "Global Hypertriglyceridemia Treatment Market Analysis."
3. U.S. Food and Drug Administration. (2012). "Vascepa (icosapent ethyl) Approval Information."
4. Amarin Corporation. (2022). "Annual Report 2021."
5. Industry Analysts. (2023). "Forecast: Lipid Management Drugs Market, 2022–2027."