NUTRILIPID 20% Drug Patent Profile
When do Nutrilipid 20% patents expire, and when can generic versions of Nutrilipid 20% launch?
Nutrilipid 20% is a drug marketed by B Braun and is included in one NDA.
The generic ingredient in NUTRILIPID 20% 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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Questions you can ask:
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Summary for NUTRILIPID 20%
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| DailyMed Link: | NUTRILIPID 20% at DailyMed |
Pharmacology for NUTRILIPID 20%
| Drug Class | Lipid Emulsion |
US Patents and Regulatory Information for NUTRILIPID 20%
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| B Braun | NUTRILIPID 20% | soybean oil | INJECTABLE;INJECTION | 019531-002 | May 28, 1993 | AP | RX | Yes | Yes | ⤷ 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 |
NUTRILIPID 20% Market Dynamics, Financial Trajectory, Patents, and Competitive Outlook
Nutrilipid 20% is an injectable soybean-oil lipid emulsion marketed by Fresenius Kabi for use as a calorie and essential-fatty-acid source in parenteral nutrition. Its commercial position is stable but mature. The product competes in a hospital procurement market shaped by supply reliability, formulation differentiation, contract pricing, pharmacy substitution, and manufacturing capacity rather than by brand-driven demand.
Public filings do not disclose Nutrilipid 20% revenue as a standalone product. Financial exposure must therefore be assessed through Fresenius Kabi’s broader Nutrition and intravenously administered products businesses. The principal commercial risks are generic or authorized-competitor substitution, hospital purchasing pressure, formulation upgrades such as mixed-oil emulsions, and manufacturing or raw-material disruptions.
What is Nutrilipid 20% and what is it used for?
Nutrilipid 20% is a 20% soybean oil injectable emulsion administered intravenously as part of parenteral nutrition. Each milliliter supplies approximately 2 kcal. The product provides calories and essential fatty acids when oral or enteral nutrition is not possible, insufficient, or contraindicated. It is used in adult and pediatric patients under the applicable prescribing information.[1]
Product specifications
| Attribute | Nutrilipid 20% |
|---|---|
| Active component | Soybean oil |
| Dosage form | Intravenous lipid emulsion |
| Concentration | 20% |
| Energy density | Approximately 2 kcal/mL |
| Primary use | Parenteral nutrition |
| Administration | Intravenous infusion |
| Manufacturer | Fresenius Kabi USA, LLC |
| FDA product type | Prescription injectable drug |
| Principal formulation issue | Lipid emulsion stability, sterility, particle size, and infusion compatibility |
Nutrilipid is commonly supplied in flexible bags in multiple fill volumes. Hospital pharmacies use it either as a component of a compounded parenteral nutrition formulation or as part of standardized nutrition protocols.
What is the FDA regulatory status of Nutrilipid 20%?
Nutrilipid 20% is an FDA-approved prescription product marketed under Fresenius Kabi’s U.S. drug application. The FDA-approved labeling covers use as a source of calories and essential fatty acids in parenteral nutrition.[1][2]
The product is not a biologic and does not have biosimilar exclusivity. It is an injectable drug subject to quality requirements for sterility, emulsion characteristics, container closure systems, and manufacturing controls.
FDA regulatory characteristics
| Regulatory issue | Status |
|---|---|
| FDA approval | Approved and marketed |
| Regulatory class | Injectable drug |
| Biologic license | Not applicable |
| Biosimilar pathway | Not applicable |
| 505(j) generic pathway | Potentially available to qualified competitors |
| New chemical entity exclusivity | Not applicable |
| Orphan-drug exclusivity | Not identified |
| Pediatric exclusivity | No product-specific period publicly identified |
| Regulatory focus | Sterility, emulsion quality, labeling, infusion safety, and manufacturing consistency |
Nutrilipid’s commercial protection comes primarily from manufacturing scale, hospital contracts, distribution, product familiarity, and supply performance. It does not depend on a current NCE exclusivity period.
When does Nutrilipid 20% lose exclusivity?
Nutrilipid 20% is a mature product and does not appear to have a current market exclusivity period comparable to a new chemical entity. The underlying soybean-oil lipid-emulsion technology has been used in parenteral nutrition for decades.
A definitive “loss of exclusivity” date is therefore less useful than a competitive-entry analysis. Potential competitors can seek approval through an abbreviated or otherwise applicable regulatory pathway, subject to FDA requirements for injectable lipid emulsions.
The absence of a prominent exclusivity cliff does not eliminate competitive risk. Hospital products can lose share gradually through:
- Contract replacement by a lower-cost supplier.
- Hospital conversion to another lipid formulation.
- Supply-chain failures.
- Product recalls or manufacturing observations.
- Preference for mixed-oil emulsions with omega-3 or olive-oil components.
- Bundled procurement across parenteral nutrition products.
What patents protect Nutrilipid 20%?
Publicly available product information does not identify a material active patent estate specifically protecting the Nutrilipid 20% soybean-oil emulsion. The core composition is based on established parenteral-nutrition technology rather than a recently introduced active pharmaceutical ingredient.
The relevant IP questions are more likely to concern manufacturing processes, container systems, emulsion stability, formulation additives, and production controls than the basic use of soybean oil as an intravenous calorie source.
Patent and exclusivity assessment
| IP category | Assessment |
|---|---|
| Core active ingredient patent | No material current protection identified |
| Composition-of-matter patent | Unlikely to provide meaningful current exclusivity |
| Method-of-use patent | No prominent product-specific method patent identified |
| Formulation patent | Potentially relevant at the process or stability level, but no material active estate publicly identified |
| Container or device patent | Could affect particular bag or closure systems |
| Orange Book-listed patent | No prominent active listing identified for Nutrilipid 20% |
| Manufacturing know-how | Commercially relevant and potentially difficult to replicate |
| Trade secrets | Likely important for emulsion production, scale-up, and quality control |
An Orange Book listing would be relevant to any Paragraph IV challenge. In the absence of a meaningful listed-patent barrier, a competitor’s principal hurdles would be pharmaceutical equivalence, bioequivalence or equivalent performance where applicable, sterile manufacturing, product quality, and commercial supply.
How many patents cover Nutrilipid 20%?
No meaningful number of active, product-specific patents can be assigned from public information. The commercial product should be treated as having a low apparent patent barrier but a potentially higher manufacturing barrier.
That distinction matters. A competitor may be able to avoid a composition patent yet still face substantial development expense. Injectable lipid emulsions require control of droplet size distribution, pH, osmolality, sterility, endotoxin levels, stability, container interaction, and infusion performance. Manufacturing deviations can create safety and regulatory problems even where the active ingredients are well known.
Which companies compete with Nutrilipid 20%?
The principal competitive set includes conventional soybean-oil emulsions, mixed-oil emulsions, and specialty lipid emulsions.
| Product | Company | Lipid profile | Competitive position |
|---|---|---|---|
| Nutrilipid 20% | Fresenius Kabi | Soybean oil | Direct conventional competitor |
| Intralipid | Baxter | Soybean oil | Long-established direct competitor |
| Clinolipid | Baxter | Olive oil and soybean oil | Mixed-oil alternative |
| SMOFlipid | Fresenius Kabi | Soybean, medium-chain triglyceride, olive, and fish oils | Premium mixed-oil alternative |
| Omegaven | Fresenius Kabi | Fish oil | Specialty fish-oil emulsion |
| Other hospital products | Multiple suppliers | Varies | Contract and regional competition |
How does Nutrilipid compare with SMOFlipid?
Nutrilipid 20% is a conventional soybean-oil emulsion. SMOFlipid contains a blend of soybean oil, medium-chain triglycerides, olive oil, and fish oil. The mixed-oil product is positioned as a more differentiated lipid formulation and may attract demand in hospitals seeking alternatives to pure soybean-oil emulsions.[3]
Nutrilipid retains advantages in familiarity, established clinical use, formulary simplicity, and likely lower acquisition cost. SMOFlipid has greater formulation differentiation but may face higher pricing and more selective use.
How does Nutrilipid compare with Intralipid?
Nutrilipid and Intralipid compete most directly because both are soybean-oil lipid emulsions used in parenteral nutrition. The practical differentiators are usually:
- Contract price.
- Bag configuration.
- Distribution reliability.
- Hospital formulary status.
- Manufacturing continuity.
- Service levels and product availability.
- Integration with the supplier’s broader nutrition portfolio.
The products may be clinically substitutable in some hospital protocols, but procurement decisions remain subject to institutional policies and physician or pharmacist review.
What market dynamics affect Nutrilipid 20% demand?
Demand is linked to hospital activity rather than consumer prescribing. The main end users are intensive-care units, neonatal and pediatric services, surgical departments, oncology units, and home-infusion providers.
Primary demand drivers
Parenteral nutrition demand rises when patients cannot receive adequate nutrition through the gastrointestinal tract. Relevant patient groups include those with intestinal failure, severe gastrointestinal disease, major surgery, critical illness, and selected neonatal conditions.
Demand is also affected by:
- Hospital admissions and procedure volumes.
- Use of parenteral nutrition in intensive care.
- Growth in home infusion.
- Neonatal and pediatric nutrition needs.
- Hospital shortages of amino acids, dextrose, vitamins, or other nutrition components.
- Clinical movement toward mixed-oil lipid formulations.
- Supplier capacity and inventory levels.
Nutrilipid can benefit from broad hospital use during shortages of competing lipid products. The reverse is also true: a manufacturing interruption can quickly reduce sales because hospitals often maintain limited inventories and rely on continuous supply.
What is the financial trajectory of Nutrilipid 20%?
Nutrilipid 20% revenue is not separately reported by Fresenius Kabi or Fresenius SE in public financial statements. The product is included within broader Fresenius Kabi operations, which report revenue across multiple therapeutic and product categories.[4]
Financial assessment
| Financial factor | Impact on Nutrilipid 20% |
|---|---|
| Standalone revenue disclosure | Not publicly reported |
| Product life cycle | Mature |
| Revenue growth potential | Low to moderate under normal conditions |
| Margin profile | Supported by sterile manufacturing and hospital supply requirements |
| Pricing power | Limited by tenders and generic-style procurement |
| Volume resilience | Supported by recurring clinical need |
| Upside from innovation | Greater for mixed-oil and specialty emulsions |
| Downside risk | Contract loss, price compression, recalls, and supply disruption |
Fresenius Kabi’s broader portfolio gives Nutrilipid strategic value beyond its individual revenue contribution. The company can offer hospitals a portfolio that includes conventional lipid emulsions, mixed-oil products, specialty nutrition products, infusion equipment, and other injectable medicines. This supports bundled contracting and account retention.
The product’s financial trajectory is therefore likely to be characterized by relatively stable recurring demand, periodic volume changes from supply events, and modest price pressure. It is unlikely to deliver the growth profile of a newly launched specialty drug.
What revenue exposure does Fresenius Kabi have to parenteral nutrition?
Fresenius Kabi has significant exposure to hospital-administered therapies, infusion products, clinical nutrition, and generic injectables. Public reports disclose segment-level or business-line performance rather than Nutrilipid-specific revenue.[4]
Nutrilipid’s economic importance should be evaluated through four channels:
- Direct product sales.
- Hospital contract retention.
- Cross-selling across the nutrition portfolio.
- Manufacturing-utilization benefits at sterile production facilities.
A mature lipid emulsion can remain strategically useful even if its individual revenue is modest. It occupies a recurring-use category, supports formulary relationships, and may protect broader account access.
What generic entry risks exist for Nutrilipid 20%?
Generic-entry risk is real but not equivalent to rapid substitution in an oral solid-dose market. The likely entry barriers include:
- Sterile injectable manufacturing capacity.
- Emulsion droplet-size control.
- Stability testing.
- Container-closure compatibility.
- Validation of aseptic processing.
- Raw-material qualification.
- Pharmacist and hospital formulary adoption.
- Reliable national distribution.
- Exposure to FDA inspection and quality-system requirements.
A new entrant could use price to gain share, but hospitals may reject a lower-priced product if supply continuity is uncertain. The commercial winner must provide dependable deliveries across multiple bag sizes and maintain regulatory compliance.
What formulation patents and manufacturing barriers matter?
The most important technical barriers are likely to be non-patent manufacturing controls. Lipid emulsions are physically complex products. Failure to control particle size, phase separation, contamination, or container interaction can affect product quality and patient safety.
Relevant technical areas include:
- Emulsion homogeneity.
- Droplet-size distribution.
- Sterility and endotoxin control.
- Antioxidant and stabilizer systems.
- Bag-film compatibility.
- Light and oxygen exposure.
- Shelf-life validation.
- Compatibility with parenteral nutrition admixtures.
- Scale-up from laboratory batches to commercial production.
These barriers can preserve the incumbent’s market position even when formal patent protection is limited.
What patent litigation or Paragraph IV challenges affect Nutrilipid 20%?
No prominent current Paragraph IV litigation or major patent dispute specifically involving Nutrilipid 20% is identified in the public record reviewed for this assessment. The lack of a visible litigation campaign is consistent with a mature product whose main competitive issues are regulatory approval, manufacturing, contracting, and supply.
A future challenger would need to evaluate any Orange Book-listed patents associated with the applicable drug application, along with process or container patents that may not create a direct FDA stay but could still support separate infringement claims.
What is the geographic coverage of Nutrilipid 20%?
The product is marketed in the United States by Fresenius Kabi. Fresenius Kabi also has international clinical-nutrition operations, but product names, formulations, regulatory approvals, and market availability vary by country.
Geographic expansion is limited by:
- Local drug registration.
- Country-specific parenteral-nutrition standards.
- Hospital procurement systems.
- Local manufacturing and import rules.
- Reimbursement practices.
- Availability of competing lipid emulsions.
- National supply-chain requirements.
The U.S. market is particularly sensitive to shortages because a small number of manufacturers supply many hospitals. International markets may have greater use of mixed-oil products or different procurement preferences.
What generic launch scenarios are most likely?
Low-price conventional entrant
A competitor could target hospital contracts with a soybean-oil lipid emulsion priced below Nutrilipid and Intralipid. This scenario would pressure margins and could cause rapid share loss in tenders.
Supply-driven entrant
A challenger could gain share during a shortage or manufacturing interruption. Hospitals may retain the substitute if the product proves reliable and receives formulary approval.
Premium formulation substitution
Mixed-oil or fish-oil products could displace Nutrilipid in selected patient populations. This would be a formulation shift rather than a conventional generic event.
Portfolio-based competition
A supplier with amino acids, dextrose, vitamins, lipid emulsions, and infusion systems could win broader hospital contracts and displace Nutrilipid as part of a bundled procurement decision.
Key Takeaways
- Nutrilipid 20% is a mature soybean-oil intravenous lipid emulsion used in parenteral nutrition.
- Fresenius Kabi does not publicly report Nutrilipid revenue separately.
- The product has no apparent NCE, biologic, or meaningful current product-specific exclusivity.
- No prominent active patent estate or Paragraph IV litigation is identified for Nutrilipid 20%.
- The strongest competitive barriers are sterile manufacturing, emulsion quality, supply reliability, and hospital contracting.
- Intralipid is the closest conventional competitor.
- SMOFlipid, Clinolipid, and Omegaven create formulation-based substitution risk.
- Financial performance is likely stable but exposed to pricing pressure, contract changes, and supply disruptions.
- Fresenius Kabi’s broader nutrition portfolio increases Nutrilipid’s strategic value beyond standalone product sales.
- Generic entry is feasible but operationally difficult because injectable lipid emulsions require specialized manufacturing and quality systems.
FAQs
Is Nutrilipid 20% a generic drug?
Nutrilipid 20% is a branded FDA-approved injectable lipid emulsion. Its soybean-oil formulation is based on established technology, and competitors may pursue applicable abbreviated or alternative approval pathways.
Is Nutrilipid 20% interchangeable with Intralipid?
Both products are soybean-oil lipid emulsions, but interchangeability depends on the applicable FDA designation, formulation details, institutional policy, and clinical judgment. Hospitals should not assume automatic substitution solely because both products contain soybean oil.
Does Nutrilipid 20% have patent protection?
No material active product-specific patent protection is apparent from publicly available information. Manufacturing, container, stability, and process rights may still affect competition.
Is Nutrilipid 20% used in neonatal nutrition?
It may be used in pediatric and neonatal parenteral nutrition under product labeling and institutional protocols. Dosing, infusion rates, monitoring, and formulation decisions are patient-specific.
What is the biggest commercial risk to Nutrilipid 20%?
The largest risk is a combination of hospital price compression and substitution by competing lipid emulsions, especially if a competitor offers dependable supply, lower contract pricing, or a formulation differentiated from pure soybean oil.
References
- U.S. Food and Drug Administration. (2024). Nutrilipid 20% injectable emulsion: Prescribing information.
- National Library of Medicine. (2024). Nutrilipid-20: DailyMed drug label.
- Fresenius Kabi. (2024). SMOFlipid injectable emulsion: Prescribing information.
- Fresenius SE & Co. KGaA. (2024). Annual report 2024.
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