NDAINTRAVENOUSEMULSION
Approved
Jul 2016
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
5
Data completeness
4/8 — Partial
SMOFLIPID 20% (smoflipid) by Fresenius Kabi is acids. Approved for including term, preterm neonates, a source of calories and 4 more indications. First approved in 2016.
Drug data last refreshed 11h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
SMOFLIPID 20% is an intravenous lipid emulsion containing a mixture of soybean oil, medium-chain triglycerides, olive oil, and fish oil, designed to provide essential fatty acids and calories for parenteral nutrition. It is indicated for term and preterm neonates when enteral nutrition is not possible, insufficient, or contraindicated. The drug works through beta oxidation of fatty acids to generate energy, while also supporting membrane structure, bioactive molecule production, and gene expression.
Peak
Product is at peak commercial maturity with moderate competitive pressure (30), positioning the brand team to focus on market retention and operational efficiency rather than growth initiatives.
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 (7)
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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.