Last Updated: June 9, 2026

NUTRILIPID 10% Drug Patent Profile


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When do Nutrilipid 10% patents expire, and what generic alternatives are available?

Nutrilipid 10% is a drug marketed by B Braun and is included in one NDA.

The generic ingredient in NUTRILIPID 10% is soybean oil. There are thirteen drug master file entries 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 NUTRILIPID 10%
US Patents:0
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
DailyMed Link:NUTRILIPID 10% at DailyMed
Pharmacology for NUTRILIPID 10%
Drug ClassLipid Emulsion

US Patents and Regulatory Information for NUTRILIPID 10%

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 10% soybean oil INJECTABLE;INJECTION 019531-001 May 28, 1993 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

Market Dynamics and Financial Trajectory for NUTRILIPID 10%

Last updated: March 17, 2026

What is NUTRILIPID 10%?

NUTRILIPID 10% is a specialized nutritional lipid solution used in clinical nutrition, primarily for patients requiring lipid-based parenteral nutrition (PN). It contains 10% soybean oil emulsion, providing essential fatty acids and calories. The product is marketed mainly for hospital use, targeting critical care, postoperative recovery, and malnutrition management.

Market Size and Growth Drivers

Global Parenteral Nutrition Market

The global parenteral nutrition (PN) market was valued at approximately USD 4.8 billion in 2022. It is projected to grow at a compound annual growth rate (CAGR) of 5.2% from 2023 to 2030, reaching USD 7.3 billion by 2030 (Grand View Research, 2023).

NUTRILIPID 10% Share and Segment Positioning

NUTRILIPID 10% is positioned within the lipid emulsions segment of the PN market. The segment accounts for around 35-40% of total PN sales, valued at roughly USD 1.7 billion annually. Growth is driven by increasing hospital admissions for critical illness and aging populations with malnutrition.

Key Market Drivers

  • Rising incidence of malnutrition in hospitalized patients.
  • Expanding use of parenteral nutrition in intensive care units (ICUs).
  • Growing awareness of lipid emulsion benefits in providing essential fatty acids and improving clinical outcomes.
  • New regulation favoring soybean oil-based emulsions due to established safety profiles.

Regional Market Dynamics

Region Market Share (%) Growth Rate (2023-2030) Key Factors
North America 40 4.8% High ICU admission rates, advanced healthcare
Europe 30 5.3% Aging demographics, Clinical practice standards
Asia-Pacific 20 6.0% Increasing hospital infrastructure, malnutrition prevalent
Rest of World 10 4.5% Emerging markets, regulatory approvals

Competitive Landscape

Major Players

  • Fresenius Kabi
  • Baxter International
  • Bracco Imaging
  • Otsuka Pharmaceutical (now part of Bain Capital)
  • Other regional manufacturers

Market Position of NUTRILIPID 10%

NUTRILIPID 10% is marketed primarily by Fresenius Kabi, which commands about 50% of the global lipid emulsion segment. The product distinction hinges on formulation safety, stability, and compatibility with clinical protocols.

Pricing and Reimbursement

Pricing varies by region:

  • North America: USD 8-12 per 100 mL
  • Europe: EUR 7-10 per 100 mL
  • Asia-Pacific: USD 5-8 per 100 mL

Reimbursement policies influence product usage; hospitals in North America and Europe generally secure coverage for lipid emulsions through national health systems or private insurers.

Financial Trajectory

Revenue Projections

Based on market growth estimates and product market share, NUTRILIPID 10% is projected to generate:

Year Estimated Revenue (USD millions) Growth Rate (%)
2023 150 -
2025 210 16.7
2030 330 15.2

Key Revenue Drivers

  • Increasing adoption in ICU settings.
  • Expansion into emerging markets.
  • Potential formulary inclusion as standard lipid source.

Cost Considerations

  • Manufacturing costs are driven by soybean oil procurement, emulsion stability, and quality control.
  • Regulatory compliance costs are increasing, especially in markets with stringent oversight (e.g., FDA, EMA).

Risks Affecting Financial Trajectory

  • Regulatory challenges or delays for new formulations.
  • Competitive pricing pressures from generics and local manufacturers.
  • Supply chain disruptions impacting raw material availability.

Policy and Regulatory Environment

  • The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) approve lipid emulsions based on safety and efficacy data.
  • Recent guidelines emphasize minimizing the use of omega-6 fatty acids to reduce inflammatory responses, impacting formulations.
  • Most markets adhere to pharmacopeia standards, influencing manufacturing and quality standards.

Innovation and R&D Trends

  • Development of SMOFlipid, a soybean-based emulsion with added olive and fish oils, offers alternatives for patients with specific nutritional needs.
  • Ongoing clinical trials aim to demonstrate benefits of lipid emulsions with balanced omega-3 and omega-6 fatty acids.
  • Patent landscapes indicate a focus on emulsification technology, stability, and formulations with reduced adverse effects.

Key Takeaways

  • NUTRILIPID 10% is a significant product within the growing lipid emulsion segment of the parenteral nutrition market.
  • Market growth aligns with increasing hospital admissions, aging populations, and clinical awareness.
  • Revenue is expected to increase at a CAGR of approximately 15% during 2023-2030, driven by rising global demand.
  • Competition is concentrated among a few large manufacturers with established product portfolios.
  • Regulatory and reimbursement policies influence product accessibility and financial performance.

FAQs

What are the primary clinical applications of NUTRILIPID 10%?

Critical care, postoperative recovery, malnutrition management, and outpatient parenteral nutrition (OPN).

How does NUTRILIPID 10% compare to other lipid emulsions?

It provides a soybean oil-based formulation with proven safety profiles. Alternatives include fish oil-based or mixed lipid emulsions, which target specific patient needs.

What are the main factors driving market growth?

Rising hospital admissions for critical illnesses, aging populations, technological advances in lipid emulsions, and expanding healthcare infrastructure in emerging markets.

What regulatory challenges could impact NUTRILIPID 10%?

Approval delays for new formulations, evolving safety standards, and regional variation in standards for manufacturing and quality control.

How is regional reimbursement affecting product sales?

Reimbursement policies significantly influence hospital adoption; comprehensive coverage in North America and Europe supports higher sales, whereas limited policies in some markets hinder growth.


References

[1] Grand View Research. (2023). Parenteral Nutrition Market Size, Share & Trends Analysis Report.
[2] MarketWatch. (2022). Global Parenteral Nutrition Market Analysis and Forecast.
[3] European Medicines Agency. (2022). Guidelines on parenteral nutrition.

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