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 Woodward, Amneal Pharms, Apotex, Ascent Pharms Inc, Chartwell, Cspc-nbp Pharm, GLW, Mankind Pharma, Puracap Pharm Llc, Sofgen Pharms, Strides Pharma, 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. Twenty-two 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:	22
Raw Ingredient (Bulk) Api Vendors:	4
Clinical Trials:	73
Drug Prices:	Drug price trends for OMEGA-3-ACID ETHYL ESTERS
Drug Sales Revenues:	Drug sales revenues 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
National Cancer Institute (NCI)	Phase 2
The University of Texas Health Science Center at San Antonio	Early Phase 1
National Center for Advancing Translational Sciences (NCATS)	Early Phase 1

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
Wilshire Pharms Inc	OMEGA-3-ACID ETHYL ESTERS	omega-3-acid ethyl esters	CAPSULE;ORAL	211345-001	Dec 7, 2023	AB	RX	No	No
Sun Pharm	OMEGA-3-ACID ETHYL ESTERS	omega-3-acid ethyl esters	CAPSULE;ORAL	210834-001	Jan 9, 2020	AB	RX	No	No
Ascent Pharms Inc	OMEGA-3-ACID ETHYL ESTERS	omega-3-acid ethyl esters	CAPSULE;ORAL	207420-001	Feb 25, 2019	AB	RX	No	No
Strides Pharma	OMEGA-3-ACID ETHYL ESTERS	omega-3-acid ethyl esters	CAPSULE;ORAL	203893-001	Sep 19, 2017	AB	RX	No	No
Chartwell	OMEGA-3-ACID ETHYL ESTERS	omega-3-acid ethyl esters	CAPSULE;ORAL	206455-001	Aug 7, 2019	AB	RX	No	No
Woodward	LOVAZA	omega-3-acid ethyl esters	CAPSULE;ORAL	021654-001	Nov 10, 2004	AB	RX	Yes	Yes

Expired US Patents for OMEGA-3-ACID ETHYL ESTERS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Woodward	LOVAZA	omega-3-acid ethyl esters	CAPSULE;ORAL	021654-001	Nov 10, 2004
Woodward	LOVAZA	omega-3-acid ethyl esters	CAPSULE;ORAL	021654-001	Nov 10, 2004
Woodward	LOVAZA	omega-3-acid ethyl esters	CAPSULE;ORAL	021654-001	Nov 10, 2004

OMEGA-3-ACID ETHYL ESTERS Market Analysis and Financial Projection Experimental

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

Introduction

Omega-3-acid ethyl esters, a mixture of fatty acids primarily containing eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), are widely used as prescription drugs to manage severe hypertriglyceridemia. This article delves into the market dynamics, financial trajectory, and key factors influencing the growth of the omega-3-acid ethyl esters market.

Market Size and Growth

The global omega-3 prescription drugs market, which includes omega-3-acid ethyl esters, is projected to experience significant growth. As of 2024, the market size is estimated at approximately USD 1.35 billion and is expected to expand at a Compound Annual Growth Rate (CAGR) of 4.90% by 2030[4].

Key Drivers

Several factors are driving the growth of the omega-3-acid ethyl esters market:

Increasing Health Consciousness

The rising awareness about the health benefits of omega-3 fatty acids, particularly in reducing triglyceride levels and preventing cardiovascular diseases, is a major driver. Consumers are increasingly inclined towards functional foods and dietary supplements, which has boosted the demand for omega-3-acid ethyl esters[1].

Technological Advancements

Improvements in omega-3 extraction methods, such as microwave-assisted extraction (MAE) and ultrasound-assisted extraction (UAE), have enhanced production efficiency and reduced costs. These advancements have made the production process more sustainable and efficient[2].

Aging Population

The expanding aging population, which is more susceptible to cardiovascular and other chronic conditions, is driving the demand for omega-3-acid ethyl esters. This demographic shift is particularly significant in regions like North America and Europe[4].

Regulatory Approvals and Physician Recommendations

Prescription drugs like Vascepa and Lovaza, which contain omega-3-acid ethyl esters, have received FDA approvals and are recommended by physicians for managing high triglyceride levels. This has further legitimized their use and increased market demand[3][5].

Market Restraints

Despite the growth drivers, there are several challenges that the market faces:

Supply Chain Disruptions

Supply chain disruptions can impact the accessibility and distribution of omega-3-acid ethyl esters, affecting market stability[1].

Raw Material Price Fluctuations

The prices of raw materials, such as fish oil, can fluctuate significantly, influencing the cost of production and market stability[1].

Regulatory Variations

Different regulatory standards across various regions can pose challenges for manufacturers, affecting the uniformity and compliance of omega-3-acid ethyl esters products[1].

Market Opportunities

The market presents several opportunities for growth and expansion:

Neuroprotection and Cognitive Health

There is a growing interest in using omega-3-acid ethyl esters in neuroprotection and cognitive health products, which could expand the market beyond cardiovascular health[1].

Heart Health Supplements

The increasing demand for heart health supplements provides a significant opportunity for omega-3-acid ethyl esters to penetrate deeper into the nutritional market[1].

Elder Care Nutritional Market

The potential to enter the elder care nutritional market is another area of growth, given the higher susceptibility of the elderly to cardiovascular and other chronic conditions[1].

Competitive Landscape

The competitive landscape of the omega-3-acid ethyl esters market is characterized by:

Market Share

Vascepa, a highly purified EPA formulation, is expected to hold a significant revenue share of around 47.7% in the omega-3 prescription drugs market during the forecast period[3].

Strategic Approaches

Leading market players are focusing on product innovation, strategic collaborations, and expanding their distribution networks to maintain market dominance. For example, Amarin Corporation's collaboration with Neopharm for the commercialization of VAZKEPA in Israel highlights such strategic moves[3].

Regional Analysis

The market for omega-3-acid ethyl esters varies significantly across different regions:

North America

North America, particularly the U.S., dominates the global omega-3 prescription drugs market due to the high prevalence of cardiovascular diseases and the growing demand for effective triglyceride management. The region's market is driven by increasing awareness of the therapeutic applications of omega-3 and advancements in drug formulations[4].

Europe

Europe is experiencing significant growth due to increasing awareness of cardiovascular disease prevention and the adoption of omega-3 prescription drugs. The aging population and rising healthcare expenditure in countries like Germany, France, and the UK are key drivers[4].

Asia Pacific

The Asia Pacific region is witnessing rapid growth driven by rising healthcare expenditure, an aging population, and increased consumer awareness of cardiovascular health. Key markets include China, India, and Japan, where government initiatives to improve healthcare access are supporting market development[4].

Latin America and MEA

Latin America and the Middle East & Africa (MEA) regions are also experiencing growth, driven by increasing demand for cardiovascular health management and government policies to improve healthcare coverage and access to prescription drugs[4].

Mechanism of Action and Clinical Benefits

Omega-3-acid ethyl esters work by reducing triglyceride production, increasing fatty acid metabolism, inhibiting the release of fatty acids, and increasing triglyceride clearance. They also decrease the production of very low-density lipoprotein cholesterol (VLDL-C)[5].

Financial Projections

The financial trajectory of the omega-3-acid ethyl esters market is promising, with the global omega-3 prescription drugs market expected to exceed USD 4 billion by 2037, growing at a CAGR of over 8% during the forecast period of 2025-2037[3].

Key Takeaways

• The omega-3-acid ethyl esters market is driven by increasing health consciousness, technological advancements, and an aging population.
• The market faces challenges such as supply chain disruptions, raw material price fluctuations, and regulatory variations.
• Opportunities for growth include expansion into neuroprotection, heart health supplements, and the elder care nutritional market.
• The competitive landscape is characterized by strategic collaborations and product innovations.
• Regional markets, particularly North America, Europe, and Asia Pacific, are significant contributors to the market growth.

FAQs

Q: What are the primary uses of omega-3-acid ethyl esters?

Omega-3-acid ethyl esters are primarily used as an adjunct to diet to reduce triglyceride levels in adult patients with severe hypertriglyceridemia.

Q: Which regions dominate the omega-3 prescription drugs market?

North America, particularly the U.S., and Europe are the dominant regions in the omega-3 prescription drugs market.

Q: What are the key drivers of the omega-3-acid ethyl esters market?

Key drivers include increasing health consciousness, technological advancements in extraction methods, and an expanding aging population.

Q: What are the main challenges faced by the omega-3-acid ethyl esters market?

Challenges include supply chain disruptions, fluctuating raw material prices, and varying regulatory standards.

Q: What is the expected financial growth of the omega-3 prescription drugs market?

The global omega-3 prescription drugs market is expected to exceed USD 4 billion by 2037, growing at a CAGR of over 8% during the forecast period of 2025-2037.

Sources

1. 360iResearch: Omega-3-Acid Ethyl Esters Market Size & Share 2025-2030.
2. MDPI: Sustainable Synthesis of Omega-3 Fatty Acid Ethyl Esters.
3. Research Nester: Omega-3 Prescription Drugs Market Size & Share.
4. Grand View Research: Omega 3 Prescription Drugs Market | Industry Report, 2030.
5. DrugBank: Omega-3-acid ethyl esters: Uses, Interactions, Mechanism of Action.