INTRALIPID 10% Drug Patent Profile
Which patents cover Intralipid 10%, and when can generic versions of Intralipid 10% launch?
Intralipid 10% is a drug marketed by Fresenius and is included in one NDA.
The generic ingredient in INTRALIPID 10% is soybean oil. There is one drug master file entry for this compound. Five suppliers are listed for this compound. Additional details are available on the soybean oil profile page.
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Summary for INTRALIPID 10%
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Clinical Trials: | 88 |
| DailyMed Link: | INTRALIPID 10% at DailyMed |
Recent Clinical Trials for INTRALIPID 10%
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Rochester | PHASE2 |
| EUROPEAN LIVER PATIENTS' ASSOCIATION | PHASE2 |
| CROWDHELIX LIMITED | PHASE2 |
Pharmacology for INTRALIPID 10%
| Drug Class | Lipid Emulsion |
US Patents and Regulatory Information for INTRALIPID 10%
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Fresenius | INTRALIPID 10% | soybean oil | INJECTABLE;INJECTION | 017643-001 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Intralipid 10% Market Dynamics, Financial Trajectory, Patent Status, and Competitive Outlook
Intralipid 10% is a mature intravenous soybean-oil lipid emulsion used as a calorie source and essential fatty-acid supplement in parenteral nutrition. Fresenius Kabi markets the product in the United States. Its commercial outlook is driven by hospital nutrition volumes, supply reliability, formulation substitution, and contract pricing rather than patent exclusivity.
Standalone revenue for Intralipid 10% is not publicly disclosed. Fresenius Kabi reports broader business segments and product categories instead of brand-level sales. The product is therefore best assessed as a mature, recurring hospital product with stable clinical demand, limited pricing power, and exposure to manufacturing and raw-material costs.
What is Intralipid 10% and how is it used?
Intralipid 10% is an injectable lipid emulsion containing soybean oil, egg phospholipids, glycerin, and water for injection. Each milliliter provides approximately 1.1 kcal and 0.1 gram of fat. The product is administered intravenously as part of parenteral nutrition when oral or enteral nutrition is inadequate or contraindicated.[1]
| Attribute | Intralipid 10% |
|---|---|
| Active nutritional component | Soybean oil |
| Lipid concentration | 10% |
| Approximate energy density | 1.1 kcal/mL |
| Primary route | Intravenous infusion |
| Main use | Parenteral nutrition |
| Key excipient | Egg phospholipids |
| U.S. sponsor/marketer | Fresenius Kabi USA |
| FDA application | NDA 018449 |
| Therapeutic category | Intravenous nutritional therapy |
| Main purchasers | Hospitals, integrated delivery networks, specialty pharmacies, home-infusion providers |
The 10% concentration is less calorie-dense than 20% and 30% lipid emulsions. Hospitals may select among concentrations based on fluid restrictions, daily calorie requirements, patient age, infusion protocols, and institutional formulary decisions.
When did Intralipid 10% lose exclusivity?
Intralipid 10% lost meaningful market exclusivity decades ago. Its original approval predates the modern Hatch-Waxman patent framework, and its core soybean-oil lipid emulsion technology is established nutritional chemistry rather than a recently protected molecular entity.
The commercial barriers today are regulatory execution, sterile manufacturing, emulsion quality, supply reliability, hospital contracts, and clinical familiarity. Patent exclusivity is not the primary protection mechanism.
What is the Orange Book status of Intralipid 10%?
Intralipid is associated with an FDA-approved NDA rather than a commercially important active patent estate. FDA’s Drugs@FDA database identifies Intralipid under NDA 018449.[2] The Orange Book records approved drug applications and any relevant patent or exclusivity information, but an old parenteral nutrition product such as Intralipid generally does not have the type of active composition-of-matter protection associated with newer pharmaceutical products.[3]
The practical conclusion is that generic or competing lipid-emulsion entry is not blocked by a long-lived Intralipid patent. Competitors instead must satisfy FDA requirements for injectable emulsions and demonstrate pharmaceutical quality, sterility, stability, and bioequivalence or other appropriate approval criteria.
What patents protect Intralipid 10%?
No widely recognized, commercially material patent is the principal barrier to U.S. competition for Intralipid 10%. The underlying formulation is based on soybean oil and conventional parenteral nutrition excipients. Any historical patents covering lipid-emulsion preparation, packaging, or manufacturing are unlikely to provide durable exclusivity for the current product.
Potentially relevant intellectual-property categories include:
| IP category | Relevance to Intralipid 10% |
|---|---|
| Composition patents | Limited relevance because soybean-oil emulsions are established technology |
| Formulation patents | Could cover droplet size, emulsifier ratios, stability, or specific excipients |
| Manufacturing patents | Could cover homogenization, sterilization, filling, or emulsion control |
| Container patents | Could cover bags, ports, oxygen barriers, or storage systems |
| Method-of-use patents | Limited value for broad nutritional support because the indication is established |
| Trademark rights | Commercially relevant for the Intralipid name |
| Trade secrets | Potentially relevant to process controls, scale-up, and quality testing |
Manufacturing know-how can still create a practical barrier. Injectable lipid emulsions require control of particle size, phase separation, microbial contamination, endotoxin levels, oxidation, and container compatibility. These controls raise entry costs even when patent protection is weak.
How many patents cover Intralipid 10%?
The number of patents that could be associated with Intralipid-related formulations or manufacturing processes is not a reliable measure of commercial protection. Historical patent families may have expired, may not cover the marketed product, or may apply only in selected jurisdictions.
The relevant commercial assessment is:
- The original product is mature.
- Patent-based exclusivity is not the main driver of market share.
- FDA approval and sterile manufacturing capacity are more important than patent density.
- The brand retains value through institutional familiarity, distribution, and procurement contracts.
A patent count without claim-level review would overstate the strength of the Intralipid estate.
What is the competitive landscape for Intralipid 10%?
Intralipid competes with both conventional soybean-oil emulsions and newer mixed-oil products.
| Product | Principal lipid components | Competitive position |
|---|---|---|
| Intralipid | Soybean oil | Established, widely recognized, lower-complexity conventional formulation |
| Nutrilipid | Soybean oil | Direct or near-direct institutional alternative in the U.S. |
| Clinolipid | Olive oil and soybean oil | Alternative mixed-oil formulation |
| SMOFlipid | Soybean oil, medium-chain triglycerides, olive oil, fish oil | More diversified lipid profile and premium clinical positioning |
| Compounded or institutional alternatives | Varies | Relevant where supply, formulary, or cost conditions support substitution |
SMOFlipid and Clinolipid compete through formulation differentiation rather than a direct patent dispute over Intralipid. Mixed-oil products can command a stronger clinical or formulary position in selected patient populations, although their uptake depends on institutional protocols, published evidence, acquisition cost, and physician preference.
For a hospital, the buying decision often turns on total nutrition-program economics rather than the unit price of one bag. Factors include compatibility with amino-acid and dextrose solutions, pharmacy compounding requirements, inventory reliability, waste, nursing administration, and contract rebates.
What FDA regulatory status applies to Intralipid 10%?
Intralipid 10% is an FDA-approved prescription injectable product for use in parenteral nutrition. The FDA labeling includes contraindications and warnings concerning hypersensitivity, impaired lipid metabolism, infection risk, hypertriglyceridemia, liver dysfunction, and monitoring requirements.[1]
Regulatory risk is concentrated in manufacturing and post-market quality performance. A sterile lipid emulsion must meet stringent requirements for:
- Sterility and endotoxin control
- Emulsion particle-size distribution
- Physical stability
- Oxidative stability
- Container-closure integrity
- Drug-product uniformity
- Labeling and infusion instructions
FDA enforcement or manufacturing interruption can create disproportionate commercial effects because hospitals generally maintain limited inventories of injectable nutrition products. Supply reliability is therefore a competitive advantage.
Are there Paragraph IV challenges against Intralipid 10%?
Paragraph IV litigation is not the central competitive issue for Intralipid 10%. The product is an old approved injectable formulation, and the principal risks come from competing products, regulatory approvals, procurement changes, and manufacturing interruptions rather than a high-value patent challenge.
A potential abbreviated new drug application applicant could pursue an approval strategy if an appropriate reference product and regulatory pathway are available. The absence of meaningful active patent protection would reduce the incentive for a Paragraph IV certification and make conventional regulatory entry more commercially rational.
No major, publicly established Paragraph IV campaign has defined the U.S. market for Intralipid 10% in the same way that patent challenges have affected newer branded drugs.
What formulation patents protect competing lipid emulsions?
Formulation patents are more relevant to differentiated products such as SMOFlipid and other mixed-oil emulsions than to conventional Intralipid 10%. Potential claim areas include:
- Specific ratios of fish oil, olive oil, medium-chain triglycerides, and soybean oil
- Emulsifier systems
- Particle-size distributions
- Stability during storage
- Pediatric or neonatal formulations
- Compatibility with parenteral nutrition mixtures
- Methods for reducing oxidation or inflammatory effects
These patents may protect a particular product architecture without preventing competition from a conventional soybean-oil emulsion. They also do not automatically block substitution at the hospital formulary level.
How does Intralipid 10% compare with SMOFlipid?
Intralipid 10% is a conventional soybean-oil product with long market experience. SMOFlipid uses a combination of soybean oil, medium-chain triglycerides, olive oil, and fish oil and is positioned as a more diversified lipid emulsion.
| Factor | Intralipid 10% | SMOFlipid |
|---|---|---|
| Formulation | Soybean oil | Mixed-oil emulsion |
| Market maturity | Very high | Newer relative to Intralipid |
| Main commercial advantage | Familiarity, availability, established protocols | Formulation differentiation |
| Pricing profile | Mature-product pricing | Potentially higher value or premium pricing |
| Patent dependence | Low | More relevant for formulation and product-specific protection |
| Switching risk | Substitution within hospital formularies | Can displace conventional soybean-oil use |
| Clinical positioning | Standard nutritional lipid source | Alternative lipid profile for selected uses |
The two products can coexist because hospital formularies frequently use more than one lipid emulsion. Intralipid’s main defense is not technical exclusivity. It is entrenched use, purchasing scale, supply relationships, and operational familiarity.
What is the financial trajectory for Intralipid 10%?
The financial trajectory is likely mature and relatively stable, but brand-level revenue cannot be isolated from Fresenius Kabi’s public reporting. Fresenius Kabi discloses results for broader businesses, including nutrition and related hospital products, rather than providing a separate Intralipid 10% revenue line.[4]
Revenue drivers
The principal revenue drivers are:
- Hospital admissions requiring parenteral nutrition
- Growth in home infusion and long-term nutrition support
- Neonatal, pediatric, oncology, surgical, and intensive-care use
- Product availability during competitor shortages
- Formulary placement and group-purchasing contracts
- Expansion in emerging markets
- Mix between 10%, 20%, and 30% lipid concentrations
Revenue constraints
The product faces several structural constraints:
- Mature clinical indication
- Limited ability to raise prices without procurement resistance
- Generic and alternative-product competition
- Hospital budget controls
- Substitution toward mixed-oil products
- Commodity exposure to soybean oil, egg phospholipids, packaging, and energy
- Sterile manufacturing and quality-control costs
- Potential volume substitution from enteral nutrition
The likely financial profile is a low-growth or flat-volume product with occasional revenue increases from price, shortages, geographic expansion, or product-mix changes. Gross margins may remain attractive relative to commodity nutritional products when manufacturing utilization is high, but margins are vulnerable to plant disruption and input-cost inflation.
What licensing deals affect Intralipid 10%?
No major publicly disclosed licensing transaction is broadly recognized as the principal commercial driver of Intralipid 10% in the United States. The product is associated with Fresenius Kabi’s own hospital-products portfolio rather than a recently licensed biotechnology asset.
Distribution arrangements, group-purchasing contracts, and regional supply agreements may affect sales without being reported as brand-specific licensing deals. Their terms are generally confidential.
What patent litigation affects Intralipid 10%?
No high-value patent litigation is known to define the current U.S. market for Intralipid 10%. Litigation exposure is more likely to arise from:
- Product liability claims
- Manufacturing and quality disputes
- Contract or supply disagreements
- Regulatory enforcement
- Patent disputes involving competing mixed-oil formulations
- Trade-secret or process disputes involving injectable emulsions
This is a materially different risk profile from patented small-molecule drugs, where generic launch timing is often determined by Paragraph IV litigation and settlement dates.
What generic launch risks exist for Intralipid 10%?
A new entrant could launch if it obtains FDA approval and establishes compliant sterile manufacturing. The most credible entry scenario is a lower-priced injectable lipid emulsion competing through hospital contracts and distributor access.
| Entry factor | Risk level | Commercial effect |
|---|---|---|
| Active composition patent | Low | Limited legal delay |
| FDA approval complexity | Moderate to high | Delays or raises development cost |
| Sterile manufacturing capacity | High | Can restrict reliable supply |
| Hospital contracting | High | Incumbents retain purchasing access |
| Brand loyalty | Moderate | Clinical familiarity supports retention |
| Formulary substitution | Moderate to high | Allows rapid volume migration |
| Supply shortages | Variable | Can benefit either incumbent or entrant |
A generic entrant would need more than approval. It would need reliable supply, competitive pricing, pharmacy support, national distribution, and acceptance by group-purchasing organizations.
What is the geographic coverage of Intralipid 10%?
Intralipid has international recognition and is associated with Fresenius Kabi’s global nutrition portfolio. Geographic performance varies by regulatory approval, local hospital procurement, reimbursement, distributor relationships, and access to parenteral nutrition.
The United States is commercially important because hospital purchasing is concentrated among large systems and group-purchasing organizations. Europe and emerging markets offer volume opportunities but often have tighter public procurement pricing. Local sterile-manufacturing capacity and import requirements can determine whether a country is served through direct production, regional supply, or third-party distribution.
What is the investment outlook for Intralipid 10%?
Intralipid 10% is a defensive, mature product rather than a high-growth pharmaceutical asset. Its investment value comes from recurring hospital demand and portfolio breadth, not exclusivity or breakthrough clinical differentiation.
The principal upside factors are:
- Stable parenteral nutrition utilization
- Expansion of home-infusion services
- Competitor shortages
- Improved manufacturing utilization
- Geographic expansion
- Higher-value nutrition-product mix
The principal downside factors are:
- Price erosion
- Formulary displacement by mixed-oil emulsions
- Input-cost inflation
- Sterile manufacturing interruptions
- Regulatory quality events
- Greater use of enteral nutrition
- Hospital purchasing consolidation
Because Fresenius Kabi does not report standalone Intralipid sales, investors should evaluate the product through nutrition-segment performance, hospital-product trends, supply commentary, and evidence of product substitution rather than seeking a disclosed Intralipid revenue forecast.
Key Takeaways
- Intralipid 10% is a mature intravenous soybean-oil lipid emulsion used in parenteral nutrition.
- Fresenius Kabi markets the product in the United States under FDA NDA 018449.
- Meaningful patent exclusivity is not the main commercial protection.
- Orange Book and Paragraph IV issues are less important than FDA manufacturing compliance and sterile supply capacity.
- Competitors include Nutrilipid, Clinolipid, SMOFlipid, and other parenteral nutrition emulsions.
- Revenue is recurring but brand-level sales are not publicly disclosed.
- The product’s financial trajectory is likely stable to low-growth, with price pressure and substitution risk.
- The strongest commercial defenses are hospital contracts, supply reliability, clinical familiarity, and distribution.
- The greatest operational risks are sterile manufacturing disruption, quality events, and hospital formulary displacement.
FAQs About Intralipid 10% Market and Patent Risk
Is Intralipid 10% still commercially important?
Yes. It remains relevant because parenteral nutrition requires dependable lipid sources and hospitals value products with established protocols and broad distribution.
Can a generic company copy Intralipid 10%?
A competitor can pursue FDA approval for a comparable injectable lipid emulsion, but it must meet stringent requirements for sterile manufacturing, emulsion stability, product quality, and regulatory documentation.
Does Intralipid 10% have orphan-drug exclusivity?
No orphan-drug exclusivity is the principal commercial protection for this broadly used nutritional product.
Is SMOFlipid a direct generic substitute for Intralipid 10%?
No. SMOFlipid is a differentiated mixed-oil formulation. It can compete for the same hospital nutrition budget but is not simply a generic copy of Intralipid 10%.
Does Fresenius Kabi disclose Intralipid revenue?
No. Public financial reporting generally aggregates Intralipid within broader nutrition or hospital-product categories, preventing a reliable standalone revenue calculation.
References
-
U.S. Food and Drug Administration. (2022). Intralipid (fat emulsion) injection prescribing information. Fresenius Kabi USA, LLC.
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U.S. Food and Drug Administration. (n.d.). Drugs@FDA: Intralipid, NDA 018449. https://www.accessdata.fda.gov/scripts/cder/daf/
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U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: Orange Book. https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files
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Fresenius SE & Co. KGaA. (2024). Annual report 2023. Fresenius SE & Co. KGaA.
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Fresenius Kabi. (n.d.). Parenteral nutrition products and lipid emulsions. Fresenius Kabi.
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