Fish oil triglycerides - Generic Drug Details

What are the generic 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 are two patents 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:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	684
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for fish oil triglycerides
DailyMed Link:	fish oil triglycerides at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for fish oil triglycerides

Constraining patent/regulatory exclusivity:

INDICATED AS A SOURCE OF CALORIES AND FATTY ACIDS IN PEDIATRIC PATIENTS WITH PARENTERAL NUTRITION-ASSOCIATED CHOLESTASIS (PNAC)

Dosage:

EMULSION;INTRAVENOUS

^*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 fish oil triglycerides

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

Sponsor	Phase
Diabetes & Endocrinology Foundation	N/A
Response Pharmaceuticals	Phase 1
Collegium Medicum w Bydgoszczy	Phase 3

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	210589-002	Jul 27, 2018		RX	Yes	Yes	9,566,260		Y
Fresenius Kabi Usa	OMEGAVEN	fish oil triglycerides	EMULSION;INTRAVENOUS	210589-002	Jul 27, 2018		RX	Yes	Yes	9,629,821		Y
Fresenius Kabi Usa	OMEGAVEN	fish oil triglycerides	EMULSION;INTRAVENOUS	210589-001	Jul 27, 2018		RX	Yes	Yes
Fresenius Kabi Usa	OMEGAVEN	fish oil triglycerides	EMULSION;INTRAVENOUS	210589-001	Jul 27, 2018		RX	Yes	Yes	9,566,260		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	10,350,186
Fresenius Kabi Usa	OMEGAVEN	fish oil triglycerides	EMULSION;INTRAVENOUS	210589-001	Jul 27, 2018	10,350,186

International Patents for fish oil triglycerides

Country	Patent Number	Title	Estimated Expiration
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))
Australia	2011201893	Treatment and prevention of liver disease associated with parenteral nutrition (PN)
World Intellectual Property Organization (WIPO)	2005046669
Australia	2004289353	Treatment and prevention of liver disease associated with parenteral nutrition (PN)

Fish Oil Triglycerides: Market Dynamics and Financial Trajectory

Introduction

Fish oil, rich in omega-3 fatty acids, has been a staple in the health and wellness industry for its numerous health benefits, including the reduction of triglycerides and improvement of cardiovascular health. Here, we delve into the market dynamics and financial trajectory of fish oil triglycerides, highlighting key drivers, growth projections, and emerging trends.

Health Benefits of Fish Oil Triglycerides

Fish oil triglycerides are well-documented for their health advantages, particularly in reducing triglyceride levels, a biomarker for cardiovascular disease. Studies have shown that fish oil supplementation can lower triglycerides by up to 25% in individuals with elevated levels[5].

However, it is crucial to note that the benefits of fish oil can vary based on an individual's genetic makeup. Research indicates that only those with a specific genetic background (AG genotype at the GJB2 gene) benefit from reduced triglycerides, while others may experience an increase[2].

Market Growth Drivers

The global fish oil market is driven by several key factors:

Increased Awareness of Health Benefits

Growing awareness about the health benefits of omega-3 fatty acids is a significant driver. Consumers are increasingly seeking natural ways to support overall well-being and prevent chronic diseases, leading to a surge in demand for fish oil supplements[4].

Government Recommendations and Endorsements

Endorsements from key health organizations such as the American Heart Association (AHA) have significantly boosted consumer awareness and demand. The AHA recommends omega-3 fatty acid supplementation to reduce triglyceride levels, a widely recognized marker of cardiovascular health[3].

Expansion in Aquaculture and Cosmetics

The increase in aquaculture activities and the rise in the use of fish oil in cosmetics are additional drivers. Fish oil is now integrated into various products, including fortified foods, sophisticated formulations, and even therapeutic drugs[1].

Financial Projections

The financial trajectory of the fish oil market is robust and promising:

Global Market Size

The global fish oil market size is expected to grow from USD 3.16 billion in 2024 to USD 4.24 billion by 2033, at a Compound Annual Growth Rate (CAGR) of 5.12%[4].

Fish-Oil Based Drugs Market

The global sales of fish-oil based drugs are estimated to be worth USD 4,800.3 million in 2024 and are anticipated to reach USD 8,277.7 million by 2034, growing at a CAGR of 6.2%[3].

Emerging Trends and Innovations

Several trends are shaping the future of the fish oil triglycerides market:

Advanced Formulations

There is a significant focus on developing advanced formulations of fish oil for managing chronic diseases such as heart disease and inflammatory disorders. These formulations are designed to improve cardiovascular health, joint functions, and cognitive performance[3].

Integration into Therapeutic Areas

Fish oil is being integrated into various therapeutic areas, including cardiovascular and cognitive health. Recent studies have shown that daily fish oil supplementation can result in a 30% reduction in cardiovascular events in high-risk patients[3].

Consumer Interest in Preventive Health

The growing consumer interest in preventive health and dietary supplement measures is another key trend. As more people turn to diet and supplementation to improve heart health, the demand for fish oil-based products is expected to continue rising[3].

Specialty Retail and Online Sales

The market has seen the emergence of specialty online retailers, providing consumers with easy access to a wide variety of fish oil products. This convenience has further fueled the growth of the market[1].

Challenges and Considerations

While the market is growing, there are some challenges to consider:

Genetic Variability

The effectiveness of fish oil supplementation can vary significantly based on an individual's genetic makeup. This highlights the need for personalized and genetically informed recommendations for fish oil use[2].

Quality and Manufacturing Differences

Different types of fish oil supplements may confer similar benefits, but there is a need for more research to standardize manufacturing processes and ensure consistent quality across products[5].

Key Takeaways

• The global fish oil market is expected to grow significantly, driven by increased awareness of health benefits and government endorsements.
• Fish-oil based drugs are projected to reach USD 8,277.7 million by 2034, growing at a CAGR of 6.2%.
• Advanced formulations and integration into therapeutic areas are key trends.
• Genetic variability affects the efficacy of fish oil supplementation.
• Consumer interest in preventive health continues to drive demand.

FAQs

Q: What are the primary health benefits of fish oil triglycerides?

A: Fish oil triglycerides are primarily known for reducing triglyceride levels, improving cardiovascular health, and supporting brain and mental wellness.

Q: How does genetic makeup affect the benefits of fish oil supplementation?

A: Research indicates that individuals with a specific genetic background (AG genotype at the GJB2 gene) benefit from reduced triglycerides, while others may experience an increase.

Q: What is the projected growth rate of the global fish oil market?

A: The global fish oil market is expected to grow at a CAGR of 5.12% from 2024 to 2033.

Q: Which organizations endorse the use of fish oil for health benefits?

A: Key health organizations such as the American Heart Association (AHA) endorse the use of fish oil for reducing triglyceride levels and improving cardiovascular health.

Q: What are some emerging trends in the fish oil market?

A: Advanced formulations, integration into therapeutic areas, and growing consumer interest in preventive health are significant emerging trends.

Sources

1. Stellar Market Research: Fish Oil Market: Industry Analysis and Forecast (2023-2030)
2. University of Georgia: Fish oil benefits some, may increase triglycerides in others
3. Future Market Insights: Fish-Oil Based Drugs Market to Growth of CAGR by 2030
4. Straits Research: Fish Oil Market Size to Expand at US$4.24 billion by 2033
5. Stanford University: Fish Oil and Triglycerides | Nutrition Studies Research Group

Last updated: 2024-12-17