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Last Updated: December 22, 2024

OMEGA-3-ACID ETHYL ESTERS Drug Patent Profile


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When do Omega-3-acid Ethyl Esters patents expire, and when can generic versions of Omega-3-acid Ethyl Esters launch?

Omega-3-acid Ethyl Esters is a drug marketed by 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, and Zydus Lifesciences. and is included in fifteen NDAs.

The generic ingredient in OMEGA-3-ACID ETHYL ESTERS is omega-3-acid ethyl esters. There are thirteen drug master file entries for this compound. Twenty-two 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 Omega-3-acid Ethyl Esters

A generic version of OMEGA-3-ACID ETHYL ESTERS was approved as omega-3-acid ethyl esters by GLW on April 7th, 2014.

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Drug patent expirations by year for OMEGA-3-ACID ETHYL ESTERS
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Recent Clinical Trials for OMEGA-3-ACID ETHYL ESTERS

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SponsorPhase
National Cancer Institute (NCI)Phase 2
The University of Texas Health Science Center at San AntonioEarly 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 ClassOmega-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
Amneal Pharms OMEGA-3-ACID ETHYL ESTERS omega-3-acid ethyl esters CAPSULE;ORAL 204940-001 Nov 27, 2015 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Glw OMEGA-3-ACID ETHYL ESTERS omega-3-acid ethyl esters CAPSULE;ORAL 212504-001 Aug 19, 2020 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Chartwell OMEGA-3-ACID ETHYL ESTERS omega-3-acid ethyl esters CAPSULE;ORAL 206455-001 Aug 7, 2019 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Strides Pharma OMEGA-3-ACID ETHYL ESTERS omega-3-acid ethyl esters CAPSULE;ORAL 203893-001 Sep 19, 2017 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Mankind Pharma OMEGA-3-ACID ETHYL ESTERS omega-3-acid ethyl esters CAPSULE;ORAL 215458-001 Nov 15, 2021 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Wilshire Pharms Inc OMEGA-3-ACID ETHYL ESTERS omega-3-acid ethyl esters CAPSULE;ORAL 211345-001 Dec 7, 2023 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Apotex OMEGA-3-ACID ETHYL ESTERS omega-3-acid ethyl esters CAPSULE;ORAL 090973-001 Sep 30, 2014 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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.

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