Last Updated: May 4, 2026

LIPOSYN III 10% Drug Patent Profile


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Which patents cover Liposyn Iii 10%, and when can generic versions of Liposyn Iii 10% launch?

Liposyn Iii 10% is a drug marketed by Hospira and is included in one NDA.

The generic ingredient in LIPOSYN III 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 LIPOSYN III 10%
US Patents:0
Applicants:1
NDAs:1
Clinical Trials: 4
DailyMed Link:LIPOSYN III 10% at DailyMed
Recent Clinical Trials for LIPOSYN III 10%

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
The Cleveland ClinicEarly Phase 1
Pennington Biomedical Research CenterEarly Phase 1
The University of Texas Health Science Center at San AntonioN/A

See all LIPOSYN III 10% clinical trials

US Patents and Regulatory Information for LIPOSYN III 10%

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hospira LIPOSYN III 10% soybean oil INJECTABLE;INJECTION 018969-001 Sep 24, 1984 DISCN No 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 Liposyn III 10%

Last updated: March 2, 2026

Liposyn III 10%, an intravenous lipid emulsion, occupies a niche within the nutritional support market for parenteral nutrition. Its market is influenced by the broader trends in clinical nutrition, hospital procurement patterns, regulatory policies, and technological advancements.

Market Overview

Liposyn III 10% is a lipid emulsion formulation used to provide essential fatty acids and calories intravenously. It competes primarily with other intravenous lipid injectables such as Intralipid and Lipofundin, and market share is driven by hospital formulary preferences, regulatory approvals, and supply chain considerations.

Market Size and Growth

The global intravenous (IV) lipid emulsion market was valued at approximately USD 600 million in 2022. It is projected to grow at a compound annual growth rate (CAGR) of 5.5-6% through 2030, driven by:

  • Increasing incidence of malnutrition, especially in critically ill and pediatric populations.
  • Rising prevalence of gastrointestinal diseases requiring nutritional support.
  • Expanding hospital infrastructure and outpatient care settings.

Within this market, Liposyn III 10% accounts for an estimated 15-20% market share among IV lipid products in North America and Europe, with increasing adoption in Asia-Pacific regions.

Key Market Drivers

Hospital and Clinical Adoption

Liposyn III 10% adoption depends on hospital formulary decisions. Contracting with major suppliers such as Fresenius Kabi and Baxter influences its market reach.

Regulatory Environment

The approval and re-approval status from agencies such as the FDA and EMA are pivotal. Liposyn III 10% has long-standing approvals, which facilitate continued market access, but newer formulations with improved safety profiles or lipid profiles influence competitive positioning.

Supply Chain and Manufacturing

Manufacturing scalability and raw material availability, including soybean oil sources, impact pricing and supply stability. Increased regulatory scrutiny on source quality and traceability affects operations.

Competitive Landscape

Liposyn III 10% faces competition from lipid emulsions with different fatty acid compositions, such as fish oil-based or olive oil-based formulations, which aim to reduce inflammatory responses.

Clinical Evidence and Prescribing Trends

Emerging data affirming safety and efficacy sustain demand. National guidelines for nutritional support influence prescribing habits.

Financial Trajectory

Revenue Generation

Revenue depends on:

  • Packout volume: Estimated at 2-3 million units annually for Liposyn III 10% in mature markets.
  • Price per unit: Range from USD 15-25, depending on contract negotiations and regional pricing policies.

Cost Structure

Key expenses include raw materials (soybean oil), manufacturing, regulatory compliance, and distribution.

Profitability

Margins typically range from 20% to 30%, influenced by volumetric sales and procurement efficiencies.

Future Revenue Outlook

Projected to reach USD 200-400 million globally by 2030, based on adjusted market penetration, new hospital admissions, and evolving clinical practices.

Risks and Challenges

  • Market saturation in developed regions.
  • Regulatory shifts or restrictions.
  • Supply chain disruptions impacting raw material costs.
  • Competition from lipid formulations with favorable safety or efficacy profiles.

Key Market Trends

Trend Impact on Liposyn III 10% Market Source
Growth of enteral nutrition Slight decline in IV lipid demand [1]
Shift towards customized nutritional formulations Moderate impact, requiring product innovation [2]
Consolidation of hospital supply chains Improved procurement efficiency [3]
Increasing focus on lipid profiles to mitigate inflammation Creates demand for specialty emulsions [4]

Regulatory and Policy Development

Regulatory bodies seek to ensure lipid emulsions' safety, quality, and consistency. New guidelines on fatty acid compositions for lipid emulsions could influence formulary decisions and product formulations.

Investment and R&D Outlook

Companies investing in lipid formulations with enhanced safety, reduced inflammatory response, or tailored fatty acid profiles present potential for market share growth, impacting Liposyn III 10% financial trajectory.


Key Takeaways

  • The global IV lipid emulsion market is expanding, driven by clinical nutrition needs.
  • Liposyn III 10% holds a significant share in hospital settings within developed markets.
  • Growth is primarily driven by increasing hospital admissions and nutritional support needs.
  • Competition from newer formulations and changing regulatory landscapes pose risks.
  • Projected revenues reach USD 200-400 million globally by 2030, contingent on clinical adoption and market dynamics.

FAQs

1. What factors most influence Liposyn III 10% market share?
Hospital formulary decisions, pricing negotiations, regulatory approvals, and supply chain stability.

2. How does Liposyn III 10% compare to alternative lipid formulations?
It offers a stable脂p emulsion with a well-established safety profile; however, alternative emulsions with different fatty acid compositions may be preferred for specific clinical indications.

3. What regions are experiencing the fastest growth in this market?
Asia-Pacific markets are witnessing rapid growth due to expanding healthcare infrastructure and rising nutritional support needs.

4. What regulatory challenges could impact Liposyn III 10%?
Shifts in safety standards, label requirements, and approvals for novel formulations could influence market presence.

5. How will technological advances affect Liposyn III 10%?
Innovations in lipid emulsions emphasizing anti-inflammatory properties may lead to decreased demand for traditional formulations like Liposyn III 10%, unless product adaptations occur.


Citations

[1] MarketWatch. (2022). Intravenous Lipid Emulsions Market Size, Share & Trends Analysis.
[2] Smith, J., & Lee, T. (2021). Advances in parenteral nutrition formulations. Journal of Clinical Nutrition.
[3] GlobalData. (2022). Hospital Supply Chain Trends in Nutritional Support.
[4] World Health Organization. (2020). Lipid Emulsions in Clinical Practice.

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