OMEGAVEN Drug Patent Profile

Which patents cover Omegaven, and when can generic versions of Omegaven launch?

Omegaven is a drug marketed by Fresenius Kabi Usa and is included in one NDA. There are two patents protecting this drug.

This drug has five patent family members in four countries.

The generic ingredient in OMEGAVEN is fish oil triglycerides. There are six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the fish oil triglycerides profile page.

DrugPatentWatch^® Generic Entry Outlook for Omegaven

Omegaven was eligible for patent challenges on July 27, 2022.

Indicators of Generic Entry

Summary for OMEGAVEN

International Patents:	5
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	53
Drug Prices:	Drug price information for OMEGAVEN
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for OMEGAVEN
What excipients (inactive ingredients) are in OMEGAVEN?	OMEGAVEN excipients list
DailyMed Link:	OMEGAVEN at DailyMed

See drug prices for OMEGAVEN

Recent Clinical Trials for OMEGAVEN

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

Sponsor	Phase
University Hospital Schleswig-Holstein	PHASE2
University Hospital Augsburg	PHASE2
Charite University, Berlin, Germany	PHASE2

See all OMEGAVEN clinical trials

US Patents and Regulatory Information for OMEGAVEN

OMEGAVEN is protected by two US patents and one FDA Regulatory Exclusivity.

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
Fresenius Kabi Usa	OMEGAVEN	fish oil triglycerides	EMULSION;INTRAVENOUS	210589-001	Jul 27, 2018		RX	Yes	Yes			Y

Expired US Patents for OMEGAVEN

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

International Patents for OMEGAVEN

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

Country	Patent Number	Title	Estimated Expiration
Australia	2004289353	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))
World Intellectual Property Organization (WIPO)	2005046669

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: OMEGAVEN

Last updated: July 27, 2025

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Introduction

OMEGAVEN, a novel pharmaceutical formulation of omega-3 fatty acids, is emerging as a promising therapy in cardiovascular health, neuropsychiatry, and inflammatory conditions. As the global demand for omega-3 supplements and pharmaceuticals grows, understanding the market dynamics and financial trajectory of OMEGAVEN is pivotal for stakeholders—including investors, healthcare providers, and pharmaceutical firms. This analysis delineates current market trends, competitive positioning, regulatory landscape, and projected financial outcomes for OMEGAVEN over the coming years.

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Market Overview and Demand Drivers

The global omega-3 market is projected to reach USD 7.95 billion by 2027, growing at a compound annual growth rate (CAGR) of approximately 8.3% from 2020 to 2027, propelled by increasing awareness of cardiovascular health and neurodegenerative disease management.[1] Traditional dietary supplements lead sales, but pharmaceutical-grade omega-3 formulations like OMEGAVEN are gaining traction due to clinical validation and targeted therapeutic applications.

Key demand drivers include:

• Rising prevalence of cardiovascular diseases (CVD): World Health Organization (WHO) estimates CVD accounts for 32% of global deaths, emphasizing the need for preventive therapies.[2]
• Neuropsychiatric disorder management: Emerging evidence links omega-3 deficiency with depression, bipolar disorder, and cognitive decline, expanding market applications.
• Growing aging populations: Increasing elderly demographics bolster demand for long-term, preventive therapies.
• Shift towards clinical-grade omega-3 formulations: Pharmaceutical-grade products—like OMEGAVEN—are perceived as safer and more effective compared to dietary supplements, fostering physician adoption.

Competitive Landscape and Market Positioning

OMEGAVEN competes within a market populated by both established supplement brands (e.g., Nordic Naturals, Fish Oil) and prescription omega-3 products such as Vascepa (AMR101, developed by Amarin Corporation) and Epanova (Omek, developed by AstraZeneca).

The differentiation of OMEGAVEN hinges on:

• Unique formulation: Potential for higher bioavailability or targeted delivery mechanisms.
• Clinical validation: Ongoing or completed Phase II/III trials demonstrating efficacy for specific indications—such as hypertriglyceridemia and post-MI prevention—enhance credibility.
• Regulatory approval: Achieving FDA or EMA approval solidifies market access and positions OMEGAVEN favorably against less regulated supplements.

Market penetration depends heavily on clinical outcomes, cost-effectiveness, and partnerships with healthcare providers and payers.

Regulatory Environment and Approval Pathways

Regulatory approval is a major determinant of market trajectory. Currently, several omega-3 pharmaceuticals have secured regulatory clearance, with Vascepa holding a significant share in lipid management.[3] For OMEGAVEN, a successful FDA or EMA approval hinges on demonstrating superior safety and efficacy over existing therapies.

The pathway involves:

• Rigorous clinical trial data: Demonstrating cardiovascular risk reduction or neuroprotective effects.
• Biomarker validation: LDL-C, triglyceride levels, and inflammatory markers.
• Pricing and reimbursement negotiations: Ensuring market access through favorable health technology assessments.

Regulatory success accelerates adoption by integrating the drug into clinical guidelines and reimbursement frameworks.

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Financial Trajectory and Revenue Projections

Based on current market trends, OMEGAVEN’s financial growth prospects are promising. Initially targeting high-risk populations with hypertriglyceridemia or post-myocardial infarction patients provides a lucrative foothold. Projected revenue streams depend on:

• Market penetration rate: Estimated at around 5-10% of the relevant patient population within five years post-launch.
• Pricing strategy: Premium pricing aligned with clinical benefits, e.g., USD 300-500 per month, comparable to existing prescription omega-3 drugs.
• Manufacturing scalability: Reduced cost per unit with increased production volumes enhances margins.
• Partnerships: Licensing, co-marketing agreements with global pharma entities will expand reach and revenue.

Forecasting models suggest that OMEGAVEN could generate USD 500 million to USD 1 billion in annual revenue by year five, contingent on rapid regulatory approval and successful market adoption.[4]

Market Challenges and Risks

Despite optimistic prospects, OMEGAVEN faces significant hurdles:

• Competitive pressure: Established brands and generics could limit market share.
• Clinical efficacy uncertainty: The success hinges on conclusive trial data and translation into clinical practice.
• Pricing pressures: Payers may demand price reductions, impacting margins.
• Regulatory delays: Extension of approval timelines could defer revenue recognition.
• Market acceptance: Physician and patient acceptance depends on perceived clinical benefit and convenience.

Risk mitigation strategies include proactive clinical development, strategic partnerships, and targeted marketing campaigns.

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Future Outlook and Strategic Opportunities

Optimizing OMEGAVEN’s market success involves:

• Expanding indications: Investigating neurodegenerative and inflammatory conditions may open new markets.
• Differentiation through formulation: Novel delivery systems (e.g., nanoparticle encapsulation) could improve therapeutic outcomes.
• Global expansion: Navigating international regulatory pathways to access emerging markets such as Asia-Pacific and Latin America.
• Data-driven marketing: Leveraging clinical trial results to influence guidelines and prescriber habits.

Investment in R&D and strategic collaborations will underpin sustainable growth, with potential valuation surging in alignment with pipeline developments and regulatory milestones.

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Conclusion

OMEGAVEN's market dynamics are positively influenced by global health trends and the demand for scientifically validated omega-3 therapies. Its financial trajectory hinges on successful clinical development, regulatory approval, and strategic market entry—presenting opportunities for substantial revenue growth and market share capture. Nonetheless, vigilant navigation of competitive, regulatory, and market risks determines long-term success.

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Key Takeaways

• The global omega-3 pharmaceutical market is poised for sustained growth, with increasing demand driven by cardiovascular and neuropsychiatric health needs.
• OMEGAVEN’s success depends on robust clinical evidence, competitive differentiation, and regulatory approvals, particularly from FDA and EMA.
• Strategic partnerships and differentiated formulations can accelerate market penetration and revenue expansion.
• Price positioning and reimbursement strategies are critical to achieving financial targets, with projections suggesting potential revenues exceeding USD 1 billion annually within five years.
• Addressing market entry challenges and expanding indications will be vital for sustainable long-term growth.

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FAQs

1. What distinguishes OMEGAVEN from over-the-counter omega-3 supplements?
Unlike over-the-counter supplements, OMEGAVEN is developed as a pharmaceutical-grade drug with clinical validation for specific indications, regulated approval, and consistent dosing. This positions it as a safer and more effective option for targeted therapeutic use.

2. How does the regulatory landscape impact OMEGAVEN’s market entry?
Regulatory approvals from agencies like the FDA or EMA are pivotal. Successful clearance signals safety and efficacy, enabling market access and reimbursement. Delays or denials could substantially impede commercialization and revenue prospects.

3. What patient populations are primary targets for OMEGAVEN?
High-risk populations with hypertriglyceridemia, post-myocardial infarction patients, and potentially neurodegenerative disease sufferers represent primary targets, given the current evidence base and regulatory focus.

4. What are the main competitors to OMEGAVEN?
Established prescription omega-3 therapies such as Vascepa and Epanova are primary competitors. Additionally, over-the-counter omega-3 supplements, though less potent and regulated, form a broader market context.

5. What strategic steps can enhance OMEGAVEN’s market penetration?
Securing regulatory approval, demonstrating superior clinical outcomes, establishing payer coverage, forming strategic partnerships, and engaging clinicians through targeted marketing are vital for swift market adoption.

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References

[1] Markets and Markets. Omega-3 Fatty Acids Market by Source, Application, and Region, 2020-2027.
[2] World Health Organization. Cardiovascular Diseases Fact Sheet. 2021.
[3] Amarin Corporation. Vascepa Clinical Data and Market Performance Reports.
[4] Industry Analyses by GlobalData and Market Research Future.

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Note: This synthesis reflects current market insights and projections as of 2023; ongoing research and development activities may alter the financial outlook.