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Last Updated: April 11, 2025

Omega-3-carboxylic acids - Generic Drug Details


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What are the generic sources for omega-3-carboxylic acids and what is the scope of freedom to operate?

Omega-3-carboxylic acids is the generic ingredient in one branded drug marketed by Astrazeneca and is included in one NDA. There are seven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Omega-3-carboxylic acids has eighty-five patent family members in forty-one countries.

There is one drug master file entry for omega-3-carboxylic acids.

Summary for omega-3-carboxylic acids
International Patents:85
US Patents:7
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 1
Raw Ingredient (Bulk) Api Vendors: 71
Clinical Trials: 34
DailyMed Link:omega-3-carboxylic acids at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for omega-3-carboxylic acids
Generic Entry Date for omega-3-carboxylic acids*:
Constraining patent/regulatory exclusivity:
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 omega-3-carboxylic acids

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

SponsorPhase
Mabaret Al-Asafara HospitalsPhase 4
Assiut UniversityPhase 4
Al-Azhar UniversityPhase 1

See all omega-3-carboxylic acids clinical trials

US Patents and Regulatory Information for omega-3-carboxylic acids

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Astrazeneca EPANOVA omega-3-carboxylic acids CAPSULE;ORAL 205060-001 May 5, 2014 DISCN Yes No 8,383,678 ⤷  Try for Free Y ⤷  Try for Free
Astrazeneca EPANOVA omega-3-carboxylic acids CAPSULE;ORAL 205060-001 May 5, 2014 DISCN Yes No 9,050,309 ⤷  Try for Free Y ⤷  Try for Free
Astrazeneca EPANOVA omega-3-carboxylic acids CAPSULE;ORAL 205060-001 May 5, 2014 DISCN Yes No 9,050,308 ⤷  Try for Free ⤷  Try for Free
Astrazeneca EPANOVA omega-3-carboxylic acids CAPSULE;ORAL 205060-001 May 5, 2014 DISCN Yes No 10,117,844 ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 4 of 4 entries

Expired US Patents for omega-3-carboxylic acids

ApplicantTradenameGeneric NameDosageNDAApproval DatePatent No.Patent Expiration
Astrazeneca EPANOVA omega-3-carboxylic acids CAPSULE;ORAL 205060-001 May 5, 2014 8,383,678 ⤷  Try for Free
Astrazeneca EPANOVA omega-3-carboxylic acids CAPSULE;ORAL 205060-001 May 5, 2014 5,792,795 ⤷  Try for Free
Astrazeneca EPANOVA omega-3-carboxylic acids CAPSULE;ORAL 205060-001 May 5, 2014 9,132,112 ⤷  Try for Free
Astrazeneca EPANOVA omega-3-carboxylic acids CAPSULE;ORAL 205060-001 May 5, 2014 5,948,818 ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>Patent No.>Patent Expiration
Showing 1 to 4 of 4 entries

Omega-3 Carboxylic Acids: Market Dynamics and Financial Trajectory

Introduction

Omega-3 carboxylic acids, particularly those found in formulations like Epanova, have emerged as a significant component in the management of cardiovascular health and the treatment of hypertriglyceridemia. This article delves into the market dynamics and financial trajectory of omega-3 carboxylic acids, highlighting key drivers, challenges, and future prospects.

Market Size and Growth

The global market for omega-3 prescription drugs, which includes omega-3 carboxylic acids, is substantial and growing. As of 2024, the global omega-3 prescription drugs market size was estimated at USD 1.35 billion and is expected to expand at a CAGR of 4.90% by 2030[3].

Key Drivers of Market Growth

Increasing Prevalence of Cardiovascular Diseases

The rising cases of cardiovascular diseases and the growing need for effective triglyceride management are primary drivers of the market. Omega-3 carboxylic acids, such as those in Epanova, are approved by regulatory bodies like the US FDA for lowering triglyceride levels in patients with severe hypertriglyceridemia[5].

Expanding Aging Populations

The aging population, particularly in regions like North America and Europe, is more susceptible to chronic conditions such as cardiovascular diseases. This demographic shift contributes significantly to the demand for omega-3 prescription drugs[3].

Technological Advancements and Bioavailability

The development of new drug formulations, such as the free fatty acid form of omega-3s in Epanova, has improved bioavailability compared to traditional ethyl ester forms. This advancement enhances the efficacy of the treatment, making it more appealing to both patients and healthcare providers[5].

Regulatory Support and Insurance Coverage

Regulatory support and insurance coverage for novel omega-3 treatments are crucial factors driving market growth. In key markets such as the U.S., Germany, France, and the UK, expanding prescription options and regulatory approvals are expected to enhance the overall market landscape[3].

Regional Market Dynamics

North America

The U.S. omega-3 prescription drugs market holds a significant share in North America, driven by the increasing prevalence of cardiovascular diseases and the growing demand for effective triglyceride management. The market benefits from expanding awareness about the therapeutic applications of omega-3 and its role in reducing the risks of heart disease[3].

Europe

Europe is also experiencing significant growth due to increasing awareness of cardiovascular disease prevention and the growing adoption of omega-3 prescription drugs. The aging population in Europe further drives the demand for these drugs, supported by rising healthcare expenditure and advancements in omega-3 formulations[3].

Competitive Landscape

The market for omega-3 prescription drugs is moderately consolidated, with key players investing heavily in research and development. Companies are focusing on developing innovative solutions to improve the delivery and absorption of omega-3 fatty acids. For instance, the launch of new drug delivery systems like the AquaCelle self-emulsifying system has significantly boosted oral omega-3 absorption[1].

Financial Trajectory

Revenue Growth

The global omega-3 prescription drugs market is expected to exhibit steady growth, expanding from USD 1.35 billion in 2024 to a projected value by 2030, driven by a CAGR of 4.90%. This growth is supported by the increasing demand for effective treatments for cardiovascular diseases and hypertriglyceridemia[3].

Investment in R&D

Key players in the market are investing significantly in research and development to integrate technologies that improve the bioavailability and absorption of omega-3 fatty acids. These investments are expected to further drive market growth and enhance treatment options[1].

Challenges and Opportunities

Supply Chain and Production

The COVID-19 pandemic has highlighted challenges in the supply chain, including transportation restrictions and increased logistics costs. However, these challenges also present opportunities for companies to develop more robust and resilient supply chains[1].

Novel Production Methods

The exploration of novel sources and methods for producing long-chain omega-3 fatty acids, such as using deep-sea marine bacteria, could offer cost and scalability advantages. These innovations could make omega-3-enhanced products more accessible and affordable, expanding market reach[2].

Future Prospects

Expanding Applications

Ongoing research into additional applications of omega-3 carboxylic acids, including neurological and inflammatory disorders, creates opportunities for product utilization beyond cardiovascular health. This diversification is expected to maintain consistent revenue growth in the industry[3].

Technological Advancements

Continued advancements in drug formulations and delivery systems will be crucial for the market's future growth. Innovations like the AquaCelle self-emulsifying drug delivery system and other technologies aimed at improving bioavailability will drive the adoption of omega-3 carboxylic acids[1].

Key Takeaways

  • The global omega-3 prescription drugs market, including omega-3 carboxylic acids, is projected to grow at a CAGR of 4.90% by 2030.
  • Key drivers include the increasing prevalence of cardiovascular diseases, expanding aging populations, and technological advancements in bioavailability.
  • North America and Europe are significant markets, driven by regulatory support, insurance coverage, and growing awareness of health benefits.
  • Investments in R&D and novel production methods are expected to enhance market growth and treatment options.
  • Future prospects include expanding applications beyond cardiovascular health and continued technological innovations.

FAQs

What is the current market size of the global omega-3 prescription drugs market?

The global omega-3 prescription drugs market size was estimated at USD 1.35 billion in 2024[3].

What is the expected CAGR for the global omega-3 prescription drugs market by 2030?

The market is expected to expand at a CAGR of 4.90% by 2030[3].

What are the key drivers of the omega-3 carboxylic acids market?

Key drivers include the increasing prevalence of cardiovascular diseases, expanding aging populations, and technological advancements in bioavailability[3].

How do novel production methods impact the omega-3 carboxylic acids market?

Novel production methods, such as using deep-sea marine bacteria, could offer cost and scalability advantages, making omega-3-enhanced products more accessible and affordable[2].

What are the primary regions driving the growth of the omega-3 prescription drugs market?

North America and Europe are the primary regions driving market growth, driven by regulatory support, insurance coverage, and growing awareness of health benefits[3].

Sources

  1. Fortune Business Insights: Omega-3 Fatty Acids Market Size, Share, Growth | Forecast [2028]
  2. Good Food Institute: Novel methods for long-chain omega-3 fatty acid production
  3. Grand View Research: Omega 3 Prescription Drugs Market | Industry Report, 2030
  4. Roots Analysis: Fatty Acid Market Size, Share, Trends & Insights Report, 2035
  5. PubMed: Omega-3 carboxylic acids (Epanova): a review of its use ... - PubMed

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