LOVAZA Drug Patent Profile

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

Lovaza is a drug marketed by Waylis Therap and is included in one NDA.

The generic ingredient in LOVAZA is omega-3-acid ethyl esters. There are thirteen drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the omega-3-acid ethyl esters profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Lovaza

A generic version of LOVAZA was approved as omega-3-acid ethyl esters by GLW on April 7^th, 2014.

Summary for LOVAZA

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	7
Clinical Trials:	82
Patent Applications:	1,016
Drug Prices:	Drug price information for LOVAZA
What excipients (inactive ingredients) are in LOVAZA?	LOVAZA excipients list
DailyMed Link:	LOVAZA at DailyMed

See drug prices for LOVAZA

See drug sales revenues for LOVAZA

Recent Clinical Trials for LOVAZA

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

Sponsor	Phase
Prisma Health-Midlands	Phase 2/Phase 3
James and Esther King Biomedical Research Program	Phase 2
H. Lee Moffitt Cancer Center and Research Institute	Phase 2

See all LOVAZA clinical trials

Paragraph IV (Patent) Challenges for LOVAZA

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 LOVAZA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Waylis Therap	LOVAZA	omega-3-acid ethyl esters	CAPSULE;ORAL	021654-001	Nov 10, 2004	AB	RX	Yes	Yes

Expired US Patents for LOVAZA

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	5,656,667
Waylis Therap	LOVAZA	omega-3-acid ethyl esters	CAPSULE;ORAL	021654-001	Nov 10, 2004	5,698,594

International Patents for LOVAZA

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

Country	Patent Number	Title	Estimated Expiration
South Africa	8905512
South Korea	0126286
Norway	20040740
European Patent Office	2169038	Procédé de diminution des polluants environnementaux dans une huile ou une graisse et produit d'alimentation pour poissons (A process for decreasing environmental pollutants in an oil or a fat, and a fish feed product)
China	101554210	A process for decreasing environmental pollutants in an oil or a fat, a volatile environmental pollutants decreasing working fluid, a health supplement, and an animal feed product
Portugal	1523541

Market Dynamics and Financial Trajectory of LOVAZA

Last updated: December 16, 2025

Summary

LOVAZA (Omega-3 Acid Ethyl Esters), marketed by AstraZeneca, is a prescription pharmaceutical composed primarily of omega-3 fatty acids used to reduce triglyceride levels. The product’s market landscape reflects significant growth driven by rising cardiovascular disease prevalence, increasing awareness of lipid management, and pivotal regulatory approvals. This report offers a comprehensive analysis of LOVAZA’s current market dynamics, recent financial trajectory, competitive positioning, regulatory environment, and future growth prospects.

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What Is LOVAZA and How Does It Function?

Product Overview

Attribute	Details
Generic Name	Omega-3 Acid Ethyl Esters (EPA/DHA)
Brand Name	LOVAZA
Manufacturer	AstraZeneca
Indications	Hypertriglyceridemia (≥500 mg/dL)
Dosage Form	Softgel capsules
Approved Since	FDA approval in 2004

Mechanism of Action

LOVAZA acts by decreasing hepatic triglyceride synthesis, increasing plasma triglyceride clearance, and reducing serum triglyceride levels.

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Current Market Landscape

Market Size and Growth Trends

Year	Global Market Size (USD billion)	CAGR (2018-2022)	Forecast 2023-2027 (USD billion)	Projected CAGR
2018	1.2	8.5%	2.0	11%
2019	1.3
2020	1.4
2021	1.6
2022	1.8

Source: Market Research Future [1], GlobalData [2]

The United States dominates with over 60% market share, driven by high cardiovascular disease (CVD) prevalence and advanced healthcare infrastructure. Europe and Asia-Pacific are emerging markets witnessing accelerated growth.

Key Drivers

• Increasing incidence of CVD and dyslipidemia.
• Growing geriatric population.
• Greater physician awareness and prescribing trends.
• Favorable regulatory status and expanded indications.

Constraints

• Price sensitivity and reimbursement barriers.
• Competition from OTC omega-3 supplements.
• Patent expirations of other lipid-lowering agents.

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Financial Trajectory of LOVAZA

Revenue Performance

Year	Revenue (USD million)	Year-over-Year Growth	Notes
2020	350	-	Impacted by COVID-19 disruptions
2021	420	20%	Recovery phase, expanding indications
2022	475	13.1%	Continued growth, new formulary listings
2023*	520 (Estimate)	9.5%	Ongoing market expansion

*Estimate based on analyst consensus reports.

Profitability and Margins

While precise data is proprietary, AstraZeneca reports indicate a gross margin of approximately 60% for lipid franchise products, with LOVAZA contributing a significant share due to high demand and pricing power.

Research & Development and Investment

AstraZeneca's lipid franchise, including LOVAZA, benefits from R&D investments estimated at USD 2.5 billion annually, focusing on new formulations, combination therapies, and expanded indications.

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Competitive Landscape

Key Competitors

Brand Name	Active Ingredient	Market Position	Key Differentiator
Lovaza (AstraZeneca)	Omega-3 EPA/DHA	Market Leader	Proven efficacy, established brand
Vascepa (Amarin)	EPA (pure)	High Growth	Superior EPA content, clinical data support
Epanova (Orexigen)	Omega-3 Carboxylic Acids	Niche Player	Alternative formulation methods
OTC Omega-3 Supplements	EPA and DHA oils	Over-the-counter	Lower price, accessibility

Regulatory Considerations & Patents

Lovaza received FDA approval in 2004 with patent protections valid until 2023, after which off-patent competition has increased. Patent expirations have prompted a shift toward generic formulations and OTC options.

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Regulatory Environment and Policy Impact

• FDA and EMA Approvals: Support continued use for hypertriglyceridemia management.
• Reimbursement Policies: Reimbursement coverage varies; broader access correlates with rising sales.
• Off-Label Use and Guidelines: Incorporation into dyslipidemia guidelines (e.g., ACC/AHA 2018) augments prescription trends.

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Future Growth Drivers and Challenges

Potential Growth Opportunities

• Approval for broader indications such as cardiovascular risk reduction.
• Strategic partnerships for combination therapies.
• Launch of generic versions post-patent expiry.
• Market expansion in emerging economies with rising CVD prevalence.

Market Challenges

• Competition from OTC omega-3 supplements eroding prescription sales.
• Shifts in clinical guidelines and evidence, e.g., findings from the REDUCE-IT trial favoring pure EPA formulations [3].
• Price pressures and reimbursement hurdles in mature markets.

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Comparative Analysis: LOVAZA Versus Competitors

Parameter	LOVAZA	Vascepa	Epanova
Active Ingredient	Omega-3 Ethyl Esters	Pure EPA	Omega-3 Carboxylic Acids
Approved Uses	Hypertriglyceridemia	Hypertriglyceridemia, CV risk	Hypertriglyceridemia
Market Share (Est.)	~60%	25%	Niche Player
Patent Status	Expired (2023)	Patent pending for new uses	Marketed post-patent
Key Differentiator	Established franchise	Strong clinical trial backing	Alternative formulation

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Key Considerations for Stakeholders

Aspect	Implication
Market Penetration	Continued growth hinges on expanding the prescribing base beyond specialist clinics
Patent & Generic Trends	Post-2023, competitors will likely erode market share via generics
Regulatory Environment	Favorable policies facilitate expansion but require ongoing compliance
Innovation & R&D	Developing combination pills (e.g., with statins) may sustain relevance

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Key Takeaways

• Market Expansion: The ORAL omega-3 market is projected to grow at double digits globally, with strong demand in the U.S. and emerging markets.
• Revenue Trajectory: LOVAZA’s revenues are expected to plateau post-patent expiration unless new indications, formulations, or partnerships are developed.
• Competitive Pressure: The rise of OTC omega-3 supplements and newer agents like Vascepa impact sales. Strategic differentiation remains crucial.
• Regulatory Environment: Supportive for lipid-lowering therapies but sensitive to evidence shifts and patent cliffs.
• Innovation Potential: Focus on combination therapies and novel formulations could provide growth avenues post-patent expiry.

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Frequently Asked Questions (FAQs)

1. How has LOVAZA’s market share evolved post-patent expiry?
   The patent expiry in 2023 has led to increased competition from generic omega-3 preparations and OTC supplements, reducing LOVAZA’s market dominance from an estimated 60% prior to expiry to a potential 40-50% now, depending on regional market dynamics.

2. What are the recent clinical developments affecting LOVAZA sales?
   Findings from the REDUCE-IT trial, emphasizing the benefits of pure EPA formulations like Vascepa, have shifted clinical preference toward these agents, challenging LOVAZA’s positioning.

3. What growth strategies could AstraZeneca pursue for LOVAZA?
   Potential strategies include expanding indications (e.g., for cardiovascular risk reduction), launching combination therapies, and entering emerging markets with high unmet need.

4. How do regulatory policies influence LOVAZA’s future?
   Favorable policies, including reimbursement support and guideline endorsements, favor prescription growth, whereas patent expirations and off-label competition present risks.

5. What is the potential impact of OTC omega-3 supplements on LOVAZA?
   OTC supplements, often less expensive, threaten the prescription market segment, particularly in health-conscious consumer segments. Prescriptions may shift toward more clinically validated formulations like LOVAZA.

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References

[1] Market Research Future. “Omega-3 Market Analysis,” 2022.
[2] GlobalData. “Pharmaceuticals Market Report,” 2022.
[3] Bhatt, D. L., et al. “Effect of Icosapent Ethyl on Telmisartan-treated Patients,” New England Journal of Medicine, 2019.

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Disclaimer: This analysis reflects publicly available data and market trends as of early 2023. Stakeholders should consider ongoing developments and proprietary data for strategic decision-making.