FISH OIL TRIGLYCERIDES - Generic Drug Details

What are the generic drug sources for fish oil triglycerides and what is the scope of freedom to operate?

Fish oil triglycerides is the generic ingredient in one branded drug marketed by Fresenius Kabi Usa and is included in one NDA. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Fish oil triglycerides has five patent family members in four countries.

One supplier is listed for this compound.

Summary for FISH OIL TRIGLYCERIDES

International Patents:	5
US Patents:	1
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	743
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for FISH OIL TRIGLYCERIDES
DailyMed Link:	FISH OIL TRIGLYCERIDES at DailyMed

Recent Clinical Trials for FISH OIL TRIGLYCERIDES

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

Sponsor	Phase
MSD Pharmaceuticals LLC	PHASE4
Fundacion IDEAA	PHASE4
Fundacin Husped	PHASE4

See all FISH OIL TRIGLYCERIDES clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for FISH OIL TRIGLYCERIDES

A06AG	Enemas
A06A	DRUGS FOR CONSTIPATION
A06	DRUGS FOR CONSTIPATION
A	Alimentary tract and metabolism

US Patents and Regulatory Information for FISH OIL TRIGLYCERIDES

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Fresenius Kabi Usa	OMEGAVEN	fish oil triglycerides	EMULSION;INTRAVENOUS	210589-001	Jul 27, 2018		RX	Yes	Yes			Y
Fresenius Kabi Usa	OMEGAVEN	fish oil triglycerides	EMULSION;INTRAVENOUS	210589-002	Jul 27, 2018		RX	Yes	Yes			Y

Expired US Patents for FISH OIL TRIGLYCERIDES

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Fresenius Kabi Usa	OMEGAVEN	fish oil triglycerides	EMULSION;INTRAVENOUS	210589-002	Jul 27, 2018
Fresenius Kabi Usa	OMEGAVEN	fish oil triglycerides	EMULSION;INTRAVENOUS	210589-001	Jul 27, 2018
Fresenius Kabi Usa	OMEGAVEN	fish oil triglycerides	EMULSION;INTRAVENOUS	210589-001	Jul 27, 2018
Fresenius Kabi Usa	OMEGAVEN	fish oil triglycerides	EMULSION;INTRAVENOUS	210589-002	Jul 27, 2018
Fresenius Kabi Usa	OMEGAVEN	fish oil triglycerides	EMULSION;INTRAVENOUS	210589-002	Jul 27, 2018
Fresenius Kabi Usa	OMEGAVEN	fish oil triglycerides	EMULSION;INTRAVENOUS	210589-001	Jul 27, 2018

International Patents for FISH OIL TRIGLYCERIDES

Country	Patent Number	Title	Estimated Expiration
Australia	2004289353	Treatment and prevention of liver disease associated with parenteral nutrition (PN)
Australia	2011201893	Treatment and prevention of liver disease associated with parenteral nutrition (PN)
Canada	2545752	TRAITEMENT ET PREVENTION D'UNE MALADIE DU FOIE LIEE A LA NUTRITION PARENTERALE (PN) (TREATMENT AND PREVENTION OF LIVER DISEASE ASSOCIATED WITH PARENTERAL NUTRITION (PN))
European Patent Office	1684739	TRAITEMENT ET PREVENTION D'UNE MALADIE DU FOIE LIEE A LA NUTRITION PARENTERALE (PN) (TREATMENT AND PREVENTION OF LIVER DISEASE ASSOCIATED WITH PARENTERAL NUTRITION (PN))
World Intellectual Property Organization (WIPO)	2005046669

Market Dynamics and Financial Trajectory for Fish Oil Triglycerides

Last updated: February 19, 2026

What is the current market size and growth rate for fish oil triglycerides?

The global fish oil market was valued at approximately USD 1.4 billion in 2022. It is projected to grow at a compound annual growth rate (CAGR) of 5.8% from 2023 to 2030, driven by rising consumer health awareness and expanding applications in nutraceuticals and pharmaceuticals (Grand View Research, 2023).

Within this, fish oil triglycerides constitute the predominant form of fish oil used in supplements and therapeutic products, accounting for about 70-75% of the total fish oil market. The segment's valuation is estimated around USD 1 billion in 2022, with an anticipated CAGR of 6% over the same period.

What are the key drivers influencing the growth trajectory?

Growing consumer awareness of omega-3 benefits

Health benefits linked to omega-3 fatty acids derived from fish oil include cardiovascular health, cognitive function, and anti-inflammatory effects. Rising demand from health-conscious consumers fuels market growth.

Expansion in pharmaceutical applications

Fish oil triglycerides are increasingly incorporated into prescription formulations for managing hypertriglyceridemia and other lipid disorders. This segment is projected to experience rapid growth, with a CAGR of approximately 7% from 2023-2030.

Regulatory endorsements and guidelines

Both the U.S. FDA and European Food Safety Authority (EFSA) have issued health claims supporting omega-3 consumption for cardiovascular health. Such endorsements boost market acceptance and product development.

Supply chain and sourcing challenges

Limited fish stock and sustainability concerns restrict supply, marginally impacting prices and production capacity. The industry responds with sustainable sourcing initiatives, which can influence costs.

Innovation in formulations

Development of concentrated fish oil triglyceride products with higher purity and stability enhances product efficacy and consumer appeal.

How do pricing and profit margins compare across key players?

Price range for fish oil triglycerides

The wholesale price per kilogram ranges from USD 20 to USD 35, depending on purity, source, and concentration levels. High-purity EPA/DHA concentrates command premiums.

Cost factors influencing margins

Major expenses include raw material costs, extraction, purification, and quality testing. Sustainable sourcing can escalate costs by approximately 10-15%.

Profit margins

Manufacturers report gross margins of 15-25%. Premium products, such as triglyceride-based concentrates with EPA or DHA exceeding 90%, sustain margins toward 30% due to higher pricing.

What are the competitive landscape and key industry players?

Major players include:

• BASF
• Croda International
• KD Pharma
• Croda International
• Algalife
• GC Rieber Oils

Market share distribution is highly fragmented, with the top five holding approximately 40%. Large integrated suppliers control key patents, while independent suppliers innovate in niche formulations.

What are the current regulatory developments affecting the market?

U.S. Food and Drug Administration (FDA)

Guidelines classify fish oil supplements as dietary supplements, with standard GRAS (Generally Recognized As Safe) status. Proposed regulations seek to tighten purity and labeling standards.

European Food Safety Authority (EFSA)

Claims supporting cardiovascular health require substantiation through scientific evidence. EFSA has approved specific health claims for EPA and DHA.

International standards

Codex Alimentarius and International Fish Oil Standards (IFOS) establish quality benchmarks, impacting global regulations and market entry.

How does market penetration differ regionally?

• North America: Largest market, USD 600 million in 2022, driven by supplement sales and medical use.
• Europe: USD 400 million, with growth stimulated by high health awareness and regulatory support.
• Asia-Pacific: Fastest growth, CAGR of 7%, driven by emerging markets in China and India. Production predominantly sourced domestically.

What are the implications for future R&D and investment strategies?

Investment focus is on:

• Sustainable sourcing technologies
• Enhanced delivery systems for better bioavailability
• Purification processes reducing contaminants
• Expanding pharmaceutical-grade product lines

Companies with capabilities in extraction efficiency and sustainable supply chains will gain market advantages.

Key Takeaways

• The fish oil triglyceride market is valued at approximately USD 1 billion (2022), with a CAGR of about 6%.
• Growth is driven by health claims, regulatory support, and product innovation.
• Prices range from USD 20-35/kg, with margins for premium concentrates at around 30%.
• Supply chain sustainability and technological innovations are critical for future competitiveness.
• Regional growth varies, with Asia-Pacific considered the fastest expanding market.

FAQs

What is fish oil triglyceride?
It is a naturally occurring form of fish oil where omega-3 fatty acids EPA and DHA are esterified to glycerol backbone, offering higher bioavailability compared to ethyl ester forms.

What makes fish oil triglycerides more desirable?
They have superior absorption and stability, improving therapeutic efficacy and consumer appeal, especially in pharmaceutical formulations.

Are there FDA-approved drugs using fish oil triglycerides?
Yes. Prescription drugs like Vascepa (icosapent ethyl), which contains EPA in triglyceride form, are approved for reducing cardiovascular risk.

What are the main challenges in sourcing fish oil?
Supply limitations due to overfishing, sustainability concerns, and regulatory restrictions on raw material sourcing.

How is innovation impacting the market?
Improvements in purification, encapsulation, and formulations increase bioavailability, shelf life, and consumer acceptance, influencing market competitiveness.

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References

1. Grand View Research. (2023). Fish Oil Market Size, Share & Trends Analysis Report. [Online]. Available at: [URL]
2. U.S. Food and Drug Administration. (2023). Regulation of Dietary Supplements. [Online]. Available at: [URL]
3. European Food Safety Authority. (2022). Health Claims related to Omega-3 Fatty Acids. [Online]. Available at: [URL]
4. Codex Alimentarius. (2022). Standards for Fish Oil. [Online]. Available at: [URL]