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Suppliers and packagers for omegaven
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omegaven
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Fresenius Kabi Usa | OMEGAVEN | fish oil triglycerides | EMULSION;INTRAVENOUS | 210589 | NDA | Fresenius Kabi USA, LLC | 63323-205-00 | 10 VIAL, SINGLE-DOSE in 1 CARTON (63323-205-00) / 100 mL in 1 VIAL, SINGLE-DOSE (63323-205-31) | 2018-07-27 |
| Fresenius Kabi Usa | OMEGAVEN | fish oil triglycerides | EMULSION;INTRAVENOUS | 210589 | NDA | Fresenius Kabi USA, LLC | 63323-205-50 | 10 VIAL, SINGLE-DOSE in 1 CARTON (63323-205-50) / 50 mL in 1 VIAL, SINGLE-DOSE (63323-205-21) | 2018-07-27 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
OMeGAVEN Suppliers: Who Manufactures and Supplies Omegaven (Fish Oil) in the US and EU, and What the Procurement/IP Constraints Are
Omegaven is an IV lipid emulsion based on omega-3 fatty acids (fish oil) used in pediatric and adult parenteral nutrition, particularly where alternative lipid sources are preferred. Supplier coverage is materially tied to the manufacturer of record for each market and to the branded product’s regulatory and exclusivity status, plus any bottleneck manufacturing steps for lipid emulsion fill-finish.
Because “Omegaven” is a brand name with market-specific marketing authorizations, supplier lists must be mapped by (1) country, (2) dosage form and strength, and (3) marketing authorization holder (MAH) or labeler of record for the specific distribution channel (hospital supply vs wholesaler vs tender).
H1: Omegaven suppliers (fish oil IV lipid emulsion): manufacturers, MAHs, distribution sources, and procurement risks
Which companies supply Omegaven (omega-3 fish oil) IV lipid emulsion?
Featured snippet answer: Omegaven’s supply chain is dominated by the product’s marketing authorization holder and the drug substance and fill-finish manufacturers engaged for the registered product. In procurement practice, “suppliers” typically mean labeler-of-record at the wholesaler level (US) or MAH plus national wholesale distributors (EU/EEA).
US supply: who is the labeler-of-record for Omegaven
Omegaven is sold under a branded registration in the US. In the US, procurement typically runs through major wholesalers (McKesson, Cardinal Health, AmerisourceBergen) and specialty distributors that carry hospital nutrition products. The “supplier” that matters in contracts is usually the manufacturer/labeler of record on the NDC listing plus the primary wholesaler channel that delivers to hospitals.
EU/EEA supply: who distributes under the MAH and national wholesale networks
In the EU/EEA, tender and hospital purchasing tracks:
- the MAH on the marketing authorization,
- the national wholesale distributors handling hospital contracts,
- and the batch release testing site for compliance.
Procurement note that affects supplier availability
IV lipid emulsions are regulated as sterile parenteral products with tight controls on:
- aseptic fill-finish,
- batch release COA,
- lipid composition consistency,
- and stability across storage and transport. Any change in fill-finish site or batch release unit can constrain supply even if the MAH remains unchanged.
What is the regulatory status of Omegaven that determines supplier eligibility?
Featured snippet answer: Omegaven’s market presence depends on maintaining a valid marketing authorization (EU) or NDA/BLA registration (US) with ongoing GMP compliance, batch release, and availability obligations.
FDA pathway: is Omegaven marketed under an NDA
Omegaven is marketed as a prescription sterile drug product. For supplier contracting, the key constraint is the active US listing and the firm that owns the application and labeling, which determines substitution risk and recall responsibility.
EMA pathway: is Omegaven centrally authorized
In the EU, products can be centralized, national, or mutual recognition. The supplier footprint often mirrors the MAH’s distribution model rather than the underlying lipid raw-material supplier.
What patents protect Omegaven and how does that affect supplier competition?
Featured snippet answer: Patent protection affects entry of generic or alternative branded equivalents through formulation and method-of-use claims and, where applicable, data exclusivity. Supplier diversity rises after patent and exclusivity windows close, and after biosimilar/generic substitutes are accepted on regulatory submissions.
Patent estate categories that typically shape Omegaven competition
Even when the active ingredient is “fish oil” or omega-3 fatty acids, exclusivity can be anchored on:
- lipid composition parameters (degree of saturation, ω-3/ω-6 balance),
- emulsion droplet size and stability parameters,
- manufacturing method claims (mixing, homogenization, sterilization process),
- packaging and unit-of-use constraints for sterility and compatibility,
- and clinical method-of-use indications.
Where supplier lists get constrained
- If Omegaven has unexpired formulation or process patents, alternative suppliers must launch through licensing.
- If exclusivity is still active, generic entry timing is constrained and procurement remains mostly branded supply.
When does Omegaven lose exclusivity and what generic entry risks exist?
Featured snippet answer: Exclusivity and patent expiration timing in the US is the gating factor for generic entry risk. In practice, hospitals see fewer substitutes until a parallel product is approved and launched with reliable supply.
Paragraph IV and litigation impact
For a hospital-facing product, the generic entry risk is highest when:
- a Paragraph IV filing is made against the branded patent portfolio, and
- the court timeline supports launch authorization before or after settlement terms.
Risk for alternate omega-3 IV lipid emulsions
Even without a direct generic, competing lipid emulsions (different composition, different active oil source, or different emulsion technology) can compete. Procurement “supplier” competition may occur through therapeutic alternatives rather than identical generics.
Which formulations of Omegaven are protected and how does that change suppliers?
Featured snippet answer: Different Omegaven presentations (unit size, concentration, and emulsion characteristics) can be treated as distinct procurement SKUs. Supplier coverage must map to the exact strength and fill volume ordered.
Dosage forms that drive SKU-specific procurement
For IV lipid emulsions, suppliers must match:
- concentration (mg/mL),
- total mL per container,
- container type (e.g., bag vs vial),
- compatibility with parenteral nutrition admixture systems used in hospitals,
- and the registered product label.
Manufacturing and packaging constraints that restrict substitutions
If a product uses a specific emulsification or sterilization route, a substitute may need additional bridging studies for stability and compatibility, delaying supplier availability.
What patent litigation affects Omegaven supply and market entry?
Featured snippet answer: Patent litigation alters launch timing and can change which suppliers can legally distribute an equivalent product, impacting hospital contracting.
How litigation changes procurement
- A stay or preliminary injunction can delay launch of alternatives.
- Settlement terms can require licensing, shifting market shares to the licensed supplier rather than multiple independent generic vendors.
What is the Orange Book status of Omegaven?
Featured snippet answer: Orange Book listings identify the approved NDA and patent numbers that control generic substitution. The specific outcome for supplier competition requires an Orange Book-by-NDC mapping.
Why Orange Book matters for “supplier lists”
A supplier contract is typically signed based on whether a competing product can be substituted or is authorized to launch. Orange Book patents are the legal basis for that determination.
How many suppliers are active and what does the competitive landscape look like?
Featured snippet answer: For orphaned or niche parenteral nutrition lipid products, supplier count is usually small. Competition often comes from a limited set of branded or specialty lipid emulsion providers plus any approved generics after exclusivity.
Competition channels
- Direct substitute: same indication and similar lipid emulsion profile.
- Therapeutic substitute: different omega-3 formulation or different lipid source (soy-based or MCT/LCT mixes).
- Institutional formularies: preference lists can lock in one supplier even when alternatives exist.
What are the revenue exposure and demand drivers for Omegaven supply risk?
Featured snippet answer: Omegaven demand is concentrated in:
- hospitals with neonatal and pediatric parenteral nutrition services,
- short bowel syndrome and intestinal failure indications,
- and centers using standardized parenteral nutrition protocols.
How demand concentration affects supplier risk
When demand is concentrated, stockouts become more severe. If one primary manufacturer experiences production downtime, allocation and lead times rise quickly.
Key Takeaways
- Omegaven supply is primarily determined by the marketing authorization holder for each market and the GMP drug-product manufacturing and batch-release ecosystem.
- “Suppliers” in procurement should be mapped to labeler-of-record and channel distributors, not just raw-material fish oil suppliers.
- Patent and exclusivity status governs whether additional branded or generic suppliers can launch equivalent products and compete for hospital formularies.
- Formulation and SKU-level differences (strength, container size, and emulsion characteristics) drive practical substitutability even when therapeutic intent overlaps.
FAQs
Who is the manufacturer/labeler of Omegaven on the NDC in the US?
Which wholesalers distribute Omegaven to US hospitals most reliably?
Are there approved alternative omega-3 IV lipid emulsions that can substitute for Omegaven in parenteral nutrition?
What packaging and strength variants of Omegaven matter for procurement and substitution policies?
How do patent expirations and any Paragraph IV challenges affect the timing of generic or alternative entry for Omegaven?
References
- FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. (Accessed 2026-05-26).
- EMA. European Medicines Agency: Medicines database (Omegaven). (Accessed 2026-05-26).
- FDA. Prescription Drug Product Labeling and Drug Approval Information. (Accessed 2026-05-26).
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