NDAINTRAVENOUSEMULSIONPriority Review
Approved
Jul 2018
Lifecycle
Post-LOE
Competitive Pressure
35/100
Clinical Trials
20
Data completeness
5/8 — Partial
Priority Review
OMEGAVEN (fish oil) by Fresenius Kabi is acids. Approved for pnac. First approved in 2018.
Drug data last refreshed 11h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
OMEGAVEN is an intravenous fish oil emulsion containing omega-3 fatty acids approved by FDA in July 2018 for parenteral nutrition-associated cholestasis (PNAC). It works by providing essential fatty acids that support energy production through beta-oxidation, maintain cell membrane integrity, and serve as precursors for bioactive molecules like prostaglandins. The drug is indicated for patients unable to receive nutrition orally or enterally.
LOE ApproachingPost-LOE
Product approaches loss of exclusivity in mid-2026 with limited market activity and minimal linked job openings, suggesting a mature niche market with small team footprint.
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…
Indications (1)
Clinical Trials (20)
Study to Evaluate the Adjunctive Effect of CreNeuroS™ CNS Fish Oil Plus Softgels in Patients With Major Depressive Disorder Receiving Escitalopram.
Started Jun 2026
80 enrolled
Adjunct in the Treatment of Depressive Disorder
The FORCE Trial Pilot: Fish Oil-enriched Nutrition for Radiotherapy in Cancer of the hEad and Neck
Started Jan 2026
15 enrolled
Head &Amp;Amp; Neck Squamous Cell Carcinoma
Safety Study to Evaluate the Occurrence of EFAD in Pediatric Patients With PNAC Who Require More Than Eight Weeks of Omegaven Treatment
Started Dec 2024
40 enrolled
Parenteral Nutrition Associated Liver Disease (PNALD)Essential Fatty Acid DeficiencyMalnutrition+1 more
Intravenous Fish Oil Based Lipid Emulsion to Enhance Recovery in High-Risk Cardiac Surgery Patients
Started Feb 2024
550 enrolled
Intensive Care UnitCoronary Artery Bypass Grafting (CABG)High Risk Patients+9 more
Safety of Omegaven in Pediatric Patients With Parenteral Nutrition-Associated Cholestasis (PNAC)
Started Apr 2022
0Parenteral Nutrition Associated Liver DiseaseEssential Fatty Acid DeficiencyNeurocognitive Deficit+2 more
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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.