OMACOR
LOE Approachingomega-3acid ethyl esters
NDAORALCAPSULE
Approved
Jun 2007
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
7
Data completeness
2/8 — Basic
Drug data last refreshed 7h ago · AI intelligence enriched 2mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
OMACOR is a prescription omega-3 fatty acid ethyl ester formulation delivered as an oral capsule, approved by the FDA in 2007. It is indicated for the treatment of severe hypertriglyceridemia, working to reduce triglyceride levels in patients at cardiovascular risk. The drug represents a pharmaceutical-grade intervention in lipid management for patients requiring pharmacological triglyceride control.
LOE Approaching
Product is approaching loss of exclusivity with moderate competitive pressure (30%), suggesting a consolidating team focused on market defense and generic transition planning.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (7)
A Prospective Observational Program Using Digital Technology Tools to Enhance Patient Adherence to Omacor Therapy
Started Jan 2018
3,000 enrolled
History of Myocardial InfarctionHypertriglyceridemia
A Study to Investigate How Common Pancreatic Exocrine Insufficiency (PEI) is in Patients With Type 2 Diabetes and Also to Investigate the Uptake of a Single Dose of EPANOVA® or OMACOR® in Patients With Different Degrees of PEI
Started Mar 2015
490 enrolled
Diabetes Mellitus, Type 2Exocrine Pancreatic Insufficiency
Omacor for the Treatment of Vascular Dysfunction in Patients With Type 2 Diabetes Mellitus
Started Apr 2007
34 enrolled
AtherosclerosisType 2 Diabetes Mellitus
Evaluation of Efficacy and Safety of Omacor, Co-Administered With Atorvastatin, in Subjects With Hypertriglyceridemia
Started Feb 2007
245 enrolled
Hypertriglyceridemia
A Second Open-Label Extension of a Double-Blind, Parallel, Phase IV Study to Assess the Efficacy and Safety of Adjunctive Lovaza® (Formerly Known as Omacor®) Therapy in Hypertriglyceridemic Subjects Treated With Antara™
Started Mar 2006
93 enrolled
Hypertriglyceridemia
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.