Treats pulmonary arterial hypertension (PAH) (WHO Group 1). Sold as Flolan, Veletri. Every FDA application for this active ingredient: 2 branded and 4 generic.
As of Nov 15, 2026, FDA lists 6 applications for Epoprostenol Sodium (sold as Flolan, Veletri), first approved Sep 20, 1995, with 1 new use approved and 0 published complete response letters.
| Epoprostenol Sodium | Part B | $8.0M | -19% | 203 |
| Veletri | Part D | $703K | +16% | 23 |
| Epoprostenol Sodium | Part D | $0K | -100% | 0 |
| PACE: Prostacyclin AntiCoagulation in ECMOECMO · Garrett Keim | Phase 1 / Phase 2 | Not yet recruiting | Sep 24, 2026 |
| Epoprostenol Plus Conventional Therapy in COld and Frostbite Injury (ECCO)Frostbite · University of Colorado, Denver | Phase 4 | Not yet recruiting | Feb 20, 2026 |
| Efficacy and Safety of Triple-targeted Drug Therapy in Treatment-naive Patients With Non-low-risk PAH: A Real-world, Multicenter StudyArterial Pulmonary Hypertension (PAH) · Qianfoshan Hospital | — | Recruiting | Dec 31, 2024 |
| Infusion of Prostacyclin vs Placebo for 72-hours in Mechanically Ventilated Patients With Acute Respiratory FailureAcute Respiratory Failure, Endothelial Dysfunction · Pär Johansson | Phase 2 | Recruiting | Mar 20, 2024 |
| Initial Triple Therapy Including Parenteral Treprostinil vs Initial Double Oral Therapy in PAH Group I PatientsPulmonary Arterial Hypertension · AOP Orphan Pharmaceuticals AG | Phase 4 | Recruiting | Mar 19, 2024 |
| Inhaled Milrinone and Epoprostenol for the Prevention of Difficult Cardiac Pulmonary Bypass SeparationRight Heart Failure, Right Ventricular Dysfunction · Montreal Heart Institute | Phase 2 | Recruiting | Jul 8, 2022 |
| COMPERA / COMPERA-KIDSPulmonary Arterial Hypertension (PAH), Pulmonary Hypertension (PH) · Technische Universität Dresden | — | Recruiting | May 4, 2011 |
| Sep 20, 1995 | FlolanNDA 20444 · New molecular entity | Glaxosmithkline LLC | 17 | Discontinued |
| Apr 23, 2008 | Epoprostenol SodiumANDA 78396 | Meitheal | 4 | Discontinued |
| Jun 27, 2008 | VeletriNDA 22260 · New formulation or manufacturer | Actelion | 7 | Marketed |
| Jan 15, 2021 | Epoprostenol SodiumANDA 210473 | Sun Pharm | 1 | Marketed |
| Jun 12, 2024 | Epoprostenol SodiumANDA 213913 | Mylan | 0 | Marketed |
| Dec 29, 2025 | Epoprostenol SodiumANDA 219237 | Gland | 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
Glaxosmithkline LLC
Mylan