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 is one patent 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 30, 2026. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for OMEGAVEN

International Patents:	5
US Patents:	1
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

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

Constraining patent/regulatory exclusivity:

9,566,260

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
University Hospital Muenster	PHASE2
Universitätsklinikum Hamburg-Eppendorf	PHASE2
University Hospital, Bonn	PHASE2

See all OMEGAVEN clinical trials

US Patents and Regulatory Information for OMEGAVEN

OMEGAVEN is protected by one US patents.

This potential generic entry date is based on patent 9,566,260.

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	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	210589-002	Jul 27, 2018	9,629,821
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
Fresenius Kabi Usa	OMEGAVEN	fish oil triglycerides	EMULSION;INTRAVENOUS	210589-001	Jul 27, 2018	9,629,821

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)
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

OMEGAVEN market dynamics and financial trajectory: exclusivity status, competitive pressure, and revenue outlook

Last updated: June 22, 2026

Omega-3-acid ethyl esters? Not applicable. OMEGAVEN is an intravenous lipid emulsion containing omega-3 fatty acids (fish oil) used in parenteral nutrition, with a market profile shaped by hospital formulary adoption, short-bowel syndrome (SBS) treatment concentration, and reimbursement decisions tied to outcomes and supply stability.

Key commercial drivers: (1) addressable patient pool in SBS/PN-associated liver disease (PNALD), (2) uptake of omega-3 lipid emulsions versus soybean-oil-based alternatives, (3) contracting and group purchasing organization (GPO) placement in US hospitals, and (4) regulatory labeling scope and manufacturing continuity that reduce stockout risk.

What is OMEGAVEN, who uses it, and what market dynamics drive demand?

OMEGAVEN (omega-3 fatty acids injection) is used as a lipid source in parenteral nutrition, with clinical use concentrated in patients at risk for or diagnosed with PNALD, particularly in the SBS population.

Primary demand pools

• US tertiary-care hospitals managing SBS and long-term PN.
• Pediatric and adult centers with dedicated enteral nutrition teams and PN protocols.
• Facilities participating in specialty pharmacy or in-hospital pharmacy distribution models for IV injectables.

Market dynamics that move volumes

• Clinical pathway concentration: OMEGAVEN is typically used in a narrow clinical niche, so new competitors gain share through protocol changes rather than broad switching.
• Formulary and protocol lock-in: Once a hospital builds PNALD pathways and clinician experience around one lipid emulsion, switching costs (training, nursing workflow, monitoring protocols) slow churn.
• Outcomes and lab monitoring: Adoption is linked to improvement in liver enzymes/bilirubin trends in PNALD management, and to clinician confidence in omega-3 lipid effects versus alternative oils.
• Supply chain stability: As an injectable sterile product, availability and lead times influence utilization more than average wholesale price at the point of care.
• Reimbursement and coding: Net prices are shaped by inpatient DRG bundling, hospital contract rates, and pharmacy procurement terms rather than outpatient pharmacy sticker price dynamics.

What patents protect OMEGAVEN and how strong is the patent estate?

No complete patent-protection map can be produced from the information provided in the prompt. A credible estate analysis requires Orange Book listings (if applicable), FDA labeling linkage, and a jurisdiction-by-jurisdiction patent list tied to OMEGAVEN’s NDCs, dosage forms, and indications.

Patent-landscape inputs that must exist for a defensible answer

• FDA Orange Book record(s) for each marketed OMEGAVEN NDC, including:
  • Application number (NDA vs ANDA vs 505(b)(2))
  • Listed patents (composition, method of use, manufacturing)
  • Expiration dates and any pediatric exclusivity
• Litigation or IPR/PGR history to validate enforceable scope.

Because those data are not present here, no patent numbers or expiration dates are stated.

When does OMEGAVEN lose exclusivity and what does that mean for generic or biosimilar risk?

No exclusivity timeline can be calculated without:

• the applicable FDA submission type and listed exclusivities for OMEGAVEN’s product record(s),
• patent expiration data tied to the exact marketed NDC(s),
• any relevant exclusivity like pediatric exclusivity or orphan drug exclusivity (if any).

Without that, a generic entry risk profile would be speculative. No speculative launch scenarios are provided.

What is the Orange Book status of OMEGAVEN and what does it imply for Paragraph IV challenges?

A correct Orange Book status summary requires the Orange Book listing(s) for OMEGAVEN by NDC. The prompt provides no FDA identifier(s), so the Orange Book status cannot be stated accurately, and no Paragraph IV challenge count or docket can be listed.

How does OMEGAVEN compare with alternative lipid emulsions for PNALD and SBS patients?

OMEGAVEN competes within the “lipid source for parenteral nutrition” segment. Main alternatives typically include:

• soybean-oil-based IV lipid emulsions (older standard of care in many settings),
• mixed-oil emulsions (including omega-6/omega-3 blends) where available,
• emerging or region-specific omega-3 formulations where labeling overlaps.

Competitive effect on revenue

• If alternative emulsions have equivalent or preferred institutional positioning for PNALD, clinicians may reduce OMEGAVEN usage in eligible patients.
• If payer contracts favor a specific lipid emulsion, procurement terms drive utilization more than clinical preference.
• If OMEGAVEN retains strongest evidence or is preferred for specific SBS/PNALD subgroups, it can sustain pricing even with competitors in the class.

What formulation, method-of-use, and manufacturing risks exist for OMEGAVEN competition?

For IV lipid emulsions, “generic” barriers often hinge on:

• emulsion particle size distribution and stability,
• oxidation profile and shelf-life,
• omega-3 content specification and dosing equivalence,
• sterile manufacturing controls.

A competition risk assessment requires:

• whether any alternative product is FDA-approved via ANDA vs 505(b)(2),
• whether labeling includes equivalent indication language,
• whether patents claim manufacturing processes or specific compositions.

No product-specific barrier analysis is provided because the needed FDA and patent details are not in the prompt.

What patent litigation affects OMEGAVEN and how does it influence market entry timing?

Litigation timelines and settlement effects require docket-level information (case numbers, filing dates, court, and settlement/consent decree terms) tied to OMEGAVEN’s listed patents and NDCs. None is provided.

What FDA regulatory status applies to OMEGAVEN and what does that mean for utilization?

A regulation-anchored status summary requires:

• the current approved labeling and route/dose/dilution instructions,
• indication scope (PNALD, SBS, pediatric vs adult),
• any safety communications affecting use (infusion parameters, monitoring),
• manufacturing site approvals and any recent quality events.

The prompt includes no label or FDA status details, so no regulatory claims are made.

Commercial trajectory: pricing, volumes, and revenue exposure drivers for OMEGAVEN

Without access to company financial disclosures, payer/wholesaler pricing data, or sales estimates, a quantitative revenue trajectory cannot be stated.

A defensible commercial trajectory framework for OMEGAVEN would normally track:

• US market unit volumes (vials per quarter) by NDC
• US average net price trends by contract channel (GPO vs non-GPO)
• inpatient utilization shifts tied to PNALD incidence and length-of-stay patterns
• procurement-driven share movements among lipid emulsions
• supply continuity and any recall/constraint-driven utilization dips

Those underlying data are not included in the prompt; therefore, no revenue numbers or growth rates are provided.

What generic entry risks exist for OMEGAVEN and when could they materialize?

A generic entry forecast depends on:

• remaining patent and exclusivity clocks by NDC,
• whether any competing applicants have filed ANDAs/505(b)(2) with certifications,
• whether notice letters exist (Paragraph IV for patent-listed products),
• any 30-month stay triggers and settlement terms.

No such inputs are present, so no entry-risk timeline is stated.

How does OMEGAVEN compare with competing products on market access and contracting?

A market access comparison requires data on:

• GPO contracts for each lipid emulsion,
• payer coverage policies and prior authorization requirements (if any),
• purchasing formularies at top US hospital systems,
• evidence dossiers used for P&T committee adoption.

This information is not in the prompt, so a comparative contracting assessment is not provided.

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Key Takeaways

• OMEGAVEN demand is concentrated in PNALD/SBS parenteral nutrition pathways, so volume is driven by hospital protocol adoption and supply stability more than broad outpatient prescribing dynamics.
• Competitive pressure is primarily class-based (other IV lipid emulsions) and mediated through formulary status and inpatient contracting.
• A patent, exclusivity, Orange Book, and litigation-derived timeline cannot be provided from the information in the prompt; those determinations require FDA listing and court/notice data tied to OMEGAVEN NDCs and application records.
• No quantitative financial trajectory (revenue, units, or pricing trend) can be stated without sales data or company disclosures.

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FAQs

1. How do GPO contracts typically affect IV lipid emulsion utilization in US hospitals?
2. Which clinical endpoints (bilirubin, transaminases, cholestasis markers) most influence formulary adoption for PNALD lipid emulsions?
3. What manufacturing quality attributes (emulsion stability and particle size) can determine switching barriers among omega-3 lipid emulsions?
4. How do hospital P&T committee decisions usually change when alternative lipid emulsions receive label expansion for PNALD?
5. What supply chain events most commonly create utilization drops for injectable parenteral nutrition products like OMEGAVEN?

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References

1. None cited.