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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 three 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.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be July 27, 2025. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for OMEGAVEN

International Patents:	5
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	52
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

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for OMEGAVEN

Constraining patent/regulatory exclusivity:

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

NDA:

210589

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 OMEGAVEN

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

Sponsor	Phase
Boston Children’s Hospital	Phase 2
Boston Children's Hospital	Phase 2
University of South Florida	Phase 3

See all OMEGAVEN clinical trials

US Patents and Regulatory Information for OMEGAVEN

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

This potential generic entry date is based on INDICATED AS A SOURCE OF CALORIES AND FATTY ACIDS IN PEDIATRIC PATIENTS WITH PARENTERAL NUTRITION-ASSOCIATED CHOLESTASIS (PNAC).

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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

International Patents for OMEGAVEN

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

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))
World Intellectual Property Organization (WIPO)	2005046669
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)
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))

OMEGAVEN Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for OMEGAVEN

Introduction to OMEGAVEN

OMEGAVEN, a fish oil triglycerides injectable emulsion, is a groundbreaking treatment for pediatric patients suffering from parenteral nutrition-associated cholestasis (PNAC). It is the first and only FDA-approved fish oil lipid emulsion for this condition, addressing a critical gap in the nutrition management of these vulnerable patients[4][5].

Market Need and Demand

PNAC is a serious condition that can occur in pediatric patients receiving long-term parenteral nutrition, particularly those with temporary or permanent intestinal failure. This condition is associated with increased morbidity and mortality, and can progress to liver fibrosis, hepatic failure, and death. The availability of OMEGAVEN fills a significant need, as clinicians previously had no specific lipid emulsion options for these patients[4].

Regulatory Approval and Availability

OMEGAVEN was approved by the FDA based on evidence from two open-label clinical trials involving 189 preterm, underweight, or severely ill pediatric patients with PNAC. The drug became commercially available in the United States in November 2018, after previously being available only for compassionate use[1][4].

Clinical Efficacy and Safety

The clinical trials demonstrated the efficacy and safety of OMEGAVEN. The primary efficacy endpoint was the change over time in body weight adjusted for age, with additional comparisons made to age-standardized growth charts. The trials showed that OMEGAVEN effectively reduced direct bilirubin levels and supported age-appropriate growth in treated patients[1].

Market Positioning

OMEGAVEN is part of Fresenius Kabi's portfolio, a global healthcare company specializing in medicines and technologies for infusion, transfusion, and clinical nutrition. Fresenius Kabi's strong market position and commitment to innovation have been instrumental in making OMEGAVEN widely available to meet the nutritional needs of pediatric patients with PNAC[4][5].

Financial Trajectory

Revenue Growth

Fresenius Kabi, the manufacturer of OMEGAVEN, has a history of consistent long-term growth. The company's revenues have shown a steady increase, with organic growth rates ranging from 4% to 7% annually. Given the critical need for OMEGAVEN and its unique market position, it is likely to contribute positively to Fresenius Kabi's revenue growth[3].

Market Size and CAGR

The parenteral nutrition market, where OMEGAVEN is positioned, is expected to grow at a CAGR of 3-5% from 2022 to 2026. This growth is driven by increasing awareness of the role of nutrition in patient care and the rising demand for specialized nutritional products like OMEGAVEN[3].

Cost Recovery and Pricing

The FDA allows for the recovery of direct costs associated with the use of investigational drugs like OMEGAVEN under certain conditions. This means that the price charged for OMEGAVEN may not exceed the necessary costs to recover direct expenses, ensuring that the drug remains accessible while allowing the company to cover its costs[2].

Competitive Landscape

OMEGAVEN is the first FDA-approved fish oil lipid emulsion for PNAC, giving it a unique market position. Traditional soybean oil-based lipid emulsions were previously used, but they did not address the specific needs of patients with PNAC as effectively as OMEGAVEN. This differentiation and innovation in using fish oil rich in omega-3s set OMEGAVEN apart in the market[1][4].

Future Outlook

Fresenius Kabi's vision for 2026 includes driving profitable growth from recent investments, focusing on efficiency, and leveraging a high-value pipeline of new products. OMEGAVEN is expected to be a key contributor to this growth strategy, given its critical role in addressing PNAC and the company's commitment to expanding its nutritional product offerings[3].

Key Takeaways

• Unique Market Position: OMEGAVEN is the first FDA-approved fish oil lipid emulsion for PNAC, addressing a critical need in pediatric patient care.
• Clinical Efficacy: The drug has demonstrated efficacy in reducing direct bilirubin levels and supporting age-appropriate growth in treated patients.
• Financial Growth: OMEGAVEN is expected to contribute to Fresenius Kabi's revenue growth, driven by the increasing demand for specialized nutritional products.
• Regulatory Approval: The drug's commercial availability follows FDA approval based on two open-label clinical trials.
• Competitive Advantage: OMEGAVEN's use of fish oil rich in omega-3s differentiates it from traditional soybean oil-based lipid emulsions.

FAQs

Q: What is OMEGAVEN used for? A: OMEGAVEN is used to provide calories and fatty acids for pediatric patients with parenteral nutrition-associated cholestasis (PNAC).

Q: What makes OMEGAVEN unique? A: OMEGAVEN is the first FDA-approved fish oil lipid emulsion for PNAC, rich in omega-3 fatty acids.

Q: Who manufactures OMEGAVEN? A: OMEGAVEN is manufactured by Fresenius Kabi, a global healthcare company.

Q: How was OMEGAVEN approved? A: OMEGAVEN was approved by the FDA based on evidence from two open-label clinical trials involving pediatric patients with PNAC.

Q: What is the expected market growth for OMEGAVEN? A: The parenteral nutrition market, where OMEGAVEN is positioned, is expected to grow at a CAGR of 3-5% from 2022 to 2026.

Sources

1. FDA: Drug Trials Snapshots: OMEGAVEN - FDA
2. FDA: Omegaven - FDA
3. Fresenius: Capital Markets Day 2023 Presentation - Fresenius
4. Chain Drug Review: Omegaven injectable emulsion becomes available in the U.S.
5. Fresenius Kabi: Omegaven | Fresenius Kabi - Caring For Life