You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 31, 2025

NUTRILIPID 20% Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


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 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.

AI Deep Research
Questions you can ask:
  • What is the 5 year forecast for NUTRILIPID 20%?
  • What are the global sales for NUTRILIPID 20%?
  • What is Average Wholesale Price for NUTRILIPID 20%?
Summary for NUTRILIPID 20%
US Patents:0
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
DailyMed Link:NUTRILIPID 20% at DailyMed
Drug patent expirations by year for NUTRILIPID 20%
Pharmacology for NUTRILIPID 20%
Drug ClassLipid 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 ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>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 20%

Last updated: August 5, 2025


Introduction

NUTRILIPID 20%, a specialized lipid emulsion predominantly used in parenteral nutrition, holds a significant position within the nutritional therapy segment. Developed to address malnutrition in clinical settings, especially in critical care, this pharmaceutical product combines stability, efficacy, and safety — factors that influence its market performance and financial trajectory profoundly. This analysis assesses the current market dynamics, growth drivers, competitive landscape, regulatory environment, and future financial prospects for NUTRILIPID 20%.


Market Overview and Demand Drivers

The global demand for specialized nutritional products like NUTRILIPID 20% is driven by increasing awareness of malnutrition’s impact in hospitalized and chronically ill populations. According to a 2021 report by MarketsandMarkets, the global clinical nutrition market is projected to reach USD 16.8 billion by 2026, growing at a CAGR of approximately 6% (from 2021 to 2026). Lipid emulsions constitute a substantial segment within this market, driven by multiple factors:

  • Rising Prevalence of Malnutrition and Critical Illnesses: Malnutrition affects approximately 45-60% of hospitalized patients, emphasizing the need for effective parenteral nutrition solutions [1].

  • Aging Population: The aging demographic across the US, Europe, and Asia-Pacific increases demand for nutritional support due to age-related malabsorption and chronic illnesses.

  • Advancements in Parenteral Nutrition (PN): Innovations in lipid formulations, including reduced circulatory stress and improved biocompatibility, boost acceptance and adoption of products like NUTRILIPID 20%.

  • Regulatory Endorsements: Guidelines from organizations such as ASPEN (American Society for Parenteral and Enteral Nutrition) recommend tailored lipid emulsions, including those with structured compositions, augmenting market uptake.

Market Dynamics

Competitive Landscape

NUTRILIPID 20% competes within a niche segment of lipid emulsions, adjoining products from global pharmaceutical majors such as Fresenius Kabi, B. Braun, and Baxter. Its unique selling proposition hinges on its lipid composition, stability, and clinical efficacy, positioning it favorably among parenteral lipid solutions.

  • Product Differentiation: NUTRILIPID 20% is distinguished by its balanced fatty acid profile, minimal impurities, and compatibility across infusion systems, which appeals to clinicians prioritizing safety.

  • Patent and Regulatory Environment: Patent protections, if applicable, provide a barrier to generic duplication, bolstering market exclusivity. Regulatory approvals (e.g., FDA, EMA) further cement its market standing.

  • Pricing Strategies: Premium pricing is typical for branded lipid emulsions, supported by clinical data and manufacturer reputation. However, pricing pressures from generics and regional players persist.

Market Adoption Trends

Adoption rates are influenced by:

  • Hospital Procurement Policies: Large hospitals often prefer established brands with proven safety profiles.

  • Inclusion in Clinical Guidelines: Approval and endorsement by medical societies enhance credibility.

  • Cost-Effectiveness Analyses: Demonstrating superior outcomes and reduced complications can justify premium pricing.

Distribution and Supply Chain

Diverse distribution channels, including direct hospital supply agreements, pharmaceutical distributors, and regional suppliers, influence product availability. Supply chain robustness ensures consistent delivery, vital for critical care products like NUTRILIPID 20%.


Regulatory and Reimbursement Influences

Regulatory Landscape

Regulatory approvals in key markets (US, Europe, Asia) determine market access. Stringent requirements for safety, efficacy, and manufacturing quality vectors like GxP standards guide product development and validation. Recent advancements in lipid emulsion formulations also invoke ongoing regulatory evaluations to establish clinical superiority.

Reimbursement Policies

Insurance coverage and governmental reimbursement substantially impact product adoption. Hospitals consider the cost-benefit ratio, especially where reimbursement is aligned with improved patient outcomes, shorter hospitalization durations, or reduced complication rates.


Financial Trajectory and Growth Projections

The revenue potential for NUTRILIPID 20% hinges on several factors:

  1. Market Penetration Rate
    Currently, niche but steady, with potential growth in emerging markets through partnerships and regulatory approvals.

  2. Pricing Dynamics
    Premium pricing is sustainable where clinical advantages are demonstrably superior. Volume growth might be achieved through regional expansion rather than price reductions.

  3. Regulatory Milestones
    Approvals in new markets can catalyze revenue increases, especially in Asia-Pacific and Latin America.

  4. Pipeline and Formulation Innovations
    Introduction of optimized formulations with added benefits (e.g., reduced inflammatory response) could expand indications and boost sales.

  5. Manufacturing Scale and Cost Management
    Economies of scale and enhanced manufacturing efficiency can improve margins, facilitating investment in marketing and distribution.

Forecasting Models

Based on historical growth in clinical nutrition and lipid emulsion segments, a conservative CAGR of 4-6% is plausible over the next five years, driven by increasing awareness, expanding indications, and regional market penetration.

  • Short-term outlook (next 1-2 years): Moderate revenue growth influenced by regulatory or supply chain hurdles.

  • Medium-term outlook (3-5 years): Accelerated growth as clinical guidelines favor lipid emulsions like NUTRILIPID 20% and regional markets develop.

  • Long-term prospects: Potential for market expansion through innovation, partnerships, and broader clinical acceptance.

Challenges and Risks

  • Market Saturation: Intense competition limits growth unless differentiated by clinical benefits or cost advantages.

  • Regulatory Delays: Approval hurdles in emerging markets prolong market entry timelines.

  • Pricing Pressures: Cost containment initiatives in healthcare settings restrict revenue expansion.

  • Supply Chain Disruptions: Raw material shortages, geopolitical issues, or manufacturing issues could impact availability.


Key Takeaways

  • Growing Clinical Nutrition Market: The increasing prevalence of malnutrition and critically ill patients propels demand for lipid emulsions like NUTRILIPID 20%.

  • Market Differentiation Matters: Competitive advantages stem from formulation superiority, regulatory approvals, and clinical endorsements.

  • Regional Expansion is Critical: Growth opportunities exist in emerging markets, contingent on regulatory navigation and partnerships.

  • Innovation Drives Growth: Formulation improvements and new indications could expand market share.

  • Sustainable Price Strategies: Premium pricing supported by clinical efficacy can sustain margins amid competitive pricing pressures.


Conclusion

NUTRILIPID 20% is positioned favorably within the expanding clinical nutrition landscape. Its future financial trajectory depends on strategic regulatory, commercial, and innovation initiatives that capitalize on the rising global demand. While challenges persist, the product’s differentiated profile and expanding acceptance in clinical practice forecast a positive growth trajectory, potentially yielding robust returns for stakeholders willing to navigate market complexities.


FAQs

1. What distinguishes NUTRILIPID 20% from other lipid emulsions?
It offers a balanced fatty acid profile with high stability, minimal impurities, and proven compatibility with infusion systems, enhancing safety and efficacy for parenteral nutrition.

2. Which markets present the most promising growth opportunities for NUTRILIPID 20%?
Emerging markets in Asia-Pacific, Latin America, and the Middle East show high potential due to increasing healthcare expenditure and expanding critical care facilities.

3. How do regulatory approvals affect the product’s market potential?
Regulatory approvals facilitate market entry, build clinical credibility, and influence reimbursement strategies, directly impacting sales growth.

4. What are the main risks for NUTRILIPID 20%’s financial future?
Intense competition, regulatory delays, pricing pressures, and supply chain disruptions pose the most significant risks.

5. How can innovation improve NUTRILIPID 20%’s market share?
Developing formulations with additional benefits, such as anti-inflammatory properties or tailored fatty acid compositions, can open new clinical indications and demand.


Citations

[1] MarketsandMarkets. (2021). Clinical Nutrition Market by Product, Application, End User, and Region - Global Forecast to 2026.

More… ↓

⤷  Get Started Free

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.