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 International is production. Approved for including term, preterm neonates, a source of calories and 4 more indications. First approved in 2013.
Drug data last refreshed 2h ago · AI intelligence enriched 2d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CLINOLIPID 20% is a lipid emulsion containing olive oil and soybean oil administered intravenously as a source of calories and essential fatty acids for parenteral nutrition. It is indicated for neonates (term and preterm) and patients where enteral nutrition is not possible or insufficient. The product works through beta-oxidation of fatty acids to produce energy while supporting membrane structure, bioactive molecule synthesis, and gene expression.
LOE Approaching7mo to LOE
Product faces patent expiration in April 2027 with only 0.6 years of exclusivity remaining, signaling declining team investment and transition planning.
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)
Worked on CLINOLIPID 20% at Baxter International? Share your interview experience or compensation data (+7 days Pro)
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.