FLOLAN
LOE ApproachingNDAINJECTIONINJECTABLEPriority Review
Approved
Sep 1995
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
5
Data completeness
4/8 — Partial
Priority Review
Drug data last refreshed 6h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
FLOLAN (epoprostenol) is an intravenous small-molecule prostacyclin analog approved in 1995 for pulmonary arterial hypertension (PAH). It works by directly vasodilating pulmonary and systemic arterial beds and inhibiting platelet aggregation. The drug requires continuous IV infusion via central catheter, making it a demanding but effective treatment for severely symptomatic PAH patients.
$0.471MPart D
LOE ApproachingMature product approaching loss of exclusivity with minimal Medicare Part D utilization; brand team likely small and focused on retention against erosion.
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 (5)
Evaluation of a New Thermostable Formulation of FLOLAN in Japanese Subjects
Started May 2016
10 enrolled
Cardiovascular Disease
Rapid Switch From Flolan to Remodulin in the Outpatient Clinic
Started Mar 2008
7 enrolled
Hypertension, Pulmonary
Safety, Efficacy, and Treatment Satisfaction Switching From Flolan to Remodulin Using the Crono Five Ambulatory Pump in Patients With PAH
Started Feb 2007
8 enrolled
Pulmonary Arterial Hypertension
A Transition Study From Flolan® to Remodulin® in Patients With Pulmonary Arterial Hypertension
Started Oct 2002
39 enrolled
Pulmonary Arterial HypertensionPulmonary Hypertension
Drug Use Investigation for FLOLAN (Epoprostenol) Injection 0.5mg・1.5mg
Started Aug 1999
748 enrolled
Cardiovascular Disease
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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.