OMACOR
LOE Approachingomega-3acid ethyl esters
NDAORALCAPSULE
Approved
Jun 2007
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
8
Data completeness
2/8 — Basic
Drug data last refreshed 12h ago · AI intelligence enriched Yesterday
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
OMACOR is a prescription omega-3 fatty acid ethyl ester formulation administered orally as a capsule. It is indicated for the treatment of hypertriglyceridemia and cardiovascular risk reduction. The drug works by reducing triglyceride levels in patients with elevated baseline triglycerides.
LOE Approaching
Product is in late-stage lifecycle approaching loss of exclusivity with moderate competitive pressure, suggesting team consolidation and focus on 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 (8)
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 Plus Standard Therapies In Post Myocardial Infarction (MI) Subjects Evaluation: The OPTIMISE Observational Study
Started Jul 2012
1,531 enrolled
Myocardial Infarction (MI)
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
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.