NDAINTRAVENOUSEMULSIONPriority Review
Approved
Oct 2013
Lifecycle
LOE Approaching
Competitive Pressure
35/100
Data completeness
4/8 — Partial
Priority Review
CLINOLIPID 20% (olive oil and soybean oil) by Baxter is production. Approved for including term, preterm neonates, a source of calories and 4 more indications. First approved in 2013.
Drug data last refreshed 23h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CLINOLIPID 20% is a lipid emulsion combining olive oil and soybean oil administered intravenously as a source of calories and essential fatty acids for parenteral nutrition. It is indicated for term and preterm neonates when enteral nutrition is not possible or is insufficient. The drug works through beta-oxidation of fatty acids to produce energy, while also supporting membrane structure, bioactive molecule synthesis, and gene expression regulation.
LOE Approaching10mo to LOE
Product approaching loss of exclusivity in April 2027 with less than one year remaining; brand team likely in defensive/transition mode with minimal expansion headcount.
Mechanism of Action
production. The most common mechanism of action for energy production derived from fatty acid metabolism is beta oxidation. Fatty acids are important for membrane structure and function, precursors for bioactive molecules (such as prostaglandins), and as regulators of gene expression.
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.