Last reviewed 2026-05-13 · How we verify

SMOFlipid20%

SMOFlipid20% is a marketed pharmaceutical product developed by Johane Allard, currently holding a position in the lipid emulsion market. The key composition patent for SMOFlipid20% is set to expire in 2028, providing a period of exclusivity that supports its competitive advantage. The primary risk facing SMOFlipid20% is the potential increase in competition following the patent expiry in 2028.

At a glance

Approved indications

No approved indications tracked.

Common side effects

No common side effects on file.

Key clinical trials

• Comparison of Smoflipid to Soy-based Lipid Reduction for Cholestasis Prevention in Surgical Neonates (PHASE3)
• Diagnostic Role of the "White Test" With Lipidic Solution in the Early Intraoperative Identification of Open Bile Ducts for the Prevention of Bile Leakage After Liver Resection (BiLe -Trial) (PHASE3)
• Phase 3 Study to Compare Safety and Efficacy of Smoflipid 20% to Intralipid 20% in Hospitalized Neonates and Infants (PHASE3)
• Lipid Emulsion in Cardiac Valve Replacement Surgery (NA)
• Effects of Parenteral Nutrition in HSCT (NA)
• Impact of Fish Oil-enriched Lipid Emulsion on Fatty Acid and Inflammatory Response in Infants After Surgery (NA)
• Comparison of Two Intravenous Lipid Emulsions in Home Parenteral Nutrition Patients (PHASE4)
• Crossover Study on the Effect of Omegaven in Combination With Different Lipid Emulsions in Home Parenteral Nutrition (PHASE4)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• SMOFlipid20% CI brief — competitive landscape report
• SMOFlipid20% updates RSS · CI watch RSS
• Johane Allard portfolio CI