Lowers the risk of myocardial infarction, stroke, coronary revascularization, and…. Sold as Vascepa. Every FDA application for this active ingredient: 1 branded and 12 generic.
As of Nov 15, 2026, FDA lists 13 applications for Icosapent Ethyl (sold as Vascepa), first approved Jul 26, 2012, with 1 new use approved and 0 published complete response letters.
| Vascepa | Part D | $687M | -5% | 278,910 |
| Icosapent Ethyl | Part D | $163M | +14% | 197,799 |
| Icosapent Ethyl for High-Risk Coronary Plaques Assessed by 18F-NaF PET/CTCoronary Artery Disease, Hyperlipidaemia · China National Center for Cardiovascular Diseases | Phase 4 | Not yet recruiting | Aug 13, 2026 |
| A Phase 3 Trial of DR10624 Versus Placebo in Patients With Severe HypertriglyceridemiaSevere Hypertriglyceridemia · Zhejiang Doer Biologics Co., Ltd. | Phase 3 | Not yet recruiting | Jul 2, 2026 |
| Effects of Icosapent Ethyl on Coronary Plaque, Inflammation, and Ventricular RemodelingAcute Coronary Syndromes (ACS), Chronic Coronary Syndrome · Ruijin Hospital | — | Not yet recruiting | Jun 11, 2026 |
| CreNeuroS™️CNS Fish Oil Plus Softgels Compared to Vascepa® Capsules and Deplin® Capsules in a Pharmacokinetic, Single Dose Evaluation on Healthy Adult Human Subjects Under Fasting ConditionsBioavailability · Sichuan Credit Pharmaceutical Co., Ltd. | Not applicable | Enrolling by invitation | Jan 6, 2025 |
| Effect of Icosapent-ethyl Ester (IPE) to Reduce the Residual Risk Cardiovascular Disease.Atherosclerosis Cardiovascular Disease · University of Sao Paulo | Not applicable | Not yet recruiting | Dec 6, 2024 |
| Targeting Vascular INflammation in Patients With Community-Acquired PneumoniaInflammation, Community Acquired Pneumonia (CAP) · Ottawa Heart Institute Research Corporation | Phase 3 | Recruiting | Nov 29, 2024 |
| IcoSApent ethyL to Slow Down Aortic VAlve Stenosis proGrEssionAortic Valve Stenosis · Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) | Phase 2 | Active, not recruiting | Jun 20, 2024 |
| EPA for Metastasis Trial 2Liver Metastasis, Colon Cancer · Mark A Hull, PhD FRCP | Phase 3 | Active, not recruiting | Feb 9, 2018 |
| Jul 26, 2012 | VascepaNDA 202057 · New formulation or manufacturer | Amarin Pharms | 18 | Marketed |
| May 21, 2020 | Icosapent EthylANDA 209457 | Hikma | 0 | Marketed |
| Sep 11, 2020 | Icosapent EthylANDA 209525 | Teva Pharms USA | 0 | Marketed |
| Jun 30, 2021 | Icosapent EthylANDA 209437 | Apotex | 1 | Marketed |
| Mar 8, 2023 | Icosapent EthylANDA 209499 | Dr Reddys | 0 | Marketed |
| Apr 20, 2023 | Icosapent EthylANDA 217656 | Zydus Lifesciences | 0 | Marketed |
| Sep 22, 2023 | Icosapent EthylANDA 217844 | Onesource | 0 | Marketed |
| Dec 22, 2023 | Icosapent EthylANDA 217919 | Humanwell Puracap | 0 | Marketed |
| Feb 16, 2024 | Icosapent EthylANDA 216811 | Ascent Pharms Inc | 0 | Marketed |
| Nov 20, 2024 | Icosapent EthylANDA 218899 | Qilu | 0 | Marketed |
| Dec 20, 2024 | Icosapent EthylANDA 218994 | Torrent | 0 | Marketed |
| Aug 6, 2025 | Icosapent EthylANDA 219156 | Xiamen LP Pharm Co | 0 | Marketed |
| Jun 24, 2026 | Icosapent EthylANDA 218949 | Aurobindo Pharma Ltd | 0 | Marketed |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
Hikma
Apotex
Zydus Lifesciences