NDAINJECTIONINJECTABLE
Approved
Aug 1996
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
2
Data completeness
4/8 — Partial
INTRALIPID 20% (i.v. fat emulsion) by Fresenius Kabi is acids. First approved in 1996.
Drug data last refreshed 4h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
INTRALIPID 20% is an intravenous fat emulsion designed to provide essential fatty acids and energy substrate for patients requiring parenteral nutrition or unable to tolerate oral feeding. It works through beta-oxidation of fatty acids to generate ATP, while also supporting membrane structure, prostaglandin synthesis, and gene regulation. The product is a cornerstone of critical care and nutritional support in hospital settings.
LOE Approaching
Product faces approaching loss of exclusivity with moderate competitive pressure (30%), signaling a transition team focused on lifecycle extension and hospital formulary defense rather than growth expansion.
Mechanism of Action
acids. Fatty acids serve as an important substrate for energy production. The most common mechanism of action for energy production derived from fatty acid metabolism is beta oxidation. Fatty acids are also important for membrane structure and function, as precursors for bioactive molecules (such…
Pharmacologic Class:
Lipid Emulsion
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (2)
Safety and Efficacy Study to Compare Smoflipid and Intralipid 20% in Pediatric Patients of 3 Months to 16 Years of Age
Started Dec 2019
1 enrolled
Malnutrition, Child
Phase 3 Study to Compare Safety and Efficacy of Smoflipid 20% to Intralipid 20% in Hospitalized Neonates and Infants
Started Dec 2015
204 enrolled
Hospitalized Neonates and Infants, Expected to Require Parenteral Nutrition for 28 Days
Career Relevance
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.