Flolan

(Epoprostenol)

ApprovedSmall molecule

Johnson & Johnson

Flolan is one of 70 small molecule programs targeting Pulmonary Hypertension. It is currently in Approved.

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Pulmonary HypertensionCompleted

Pulmonary EmbolismCompleted

Pulmonary HypertensionApproved

Completed

Pulmonary EmbolismApproved

Completed

Competition

Competitive Landscape

53 competitors in Pulmonary Hypertension

#DrugCompanyPhaseTrials

Viagra

VViatris Specialty LLC

Approved

22 2

Letairis

Gilead

Approved

7 3

Adempas

Bayer

Approved

6 4

Cialis

Eli Lilly

Approved

6 5

Tracleer

Johnson & Johnson

Approved

6 6

Opsumit

Johnson & Johnson

Approved

5 7

Remodulin

United Therapeutics

Approved

5 8

Primacor

Sanofi

Approved

4 9

Levitra

Bayer

Approved

2 10

Uptravi

Johnson & Johnson

Approved

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Clinical

Trials by Indication[1]

Pulmonary Hypertension1 trial

Phase IV Study of Chronic Infusional Epoprostenol for Severe Primary Pulmonary Hypertension

Completed·NNational Center for Research Resources (NCRR)·Phase 4·NCT00004754

Pulmonary Embolism1 trial

Epoprostenol in Pulmonary Embolism

Completed·UUniversitair Ziekenhuis Brussel·Phase 4·NCT01014156·14 enrolled

Pulmonary Arterial Hypertension1 trial

Epoprostenol for Injection in Patients With Pulmonary Arterial Hypertension

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT01470144·41 enrolled

Drug1 trial

Drug Use Investigation for FLOLAN (Epoprostenol) Injection 0.5mg・1.5mg

Completed· GSK logo

GSK··NCT01387191·748 enrolled

Ischemia1 trial

Combined Drug Approach to Prevent Ischemia-reperfusion Injury During Transplantation of Livers (CAPITL)

Completed·UUniversitaire Ziekenhuizen KU Leuven·Phase 2·NCT02251041·143 enrolled

Regulatory

FDA Approval Timeline[4]

Sep 20, 1995

FLOLAN

NDA NDA020444

Jun 28, 2012

VELETRI

NDA NDA022260

Sources

References

[1]
ClinicalTrials.gov — 5 trial records for Epoprostenol. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Epoprostenol compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Epoprostenol. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA022260). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Flolan. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Johnson & Johnson company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Approved[1]
Company: Johnson & Johnson

Patent Landscape[5]

Patent Cliff

Feb 2, 2027

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8598227Feb 2, 2027

8318802Mar 15, 2027

Flolan

Status by Indication[3][1]

Competitive Landscape

Trials by Indication[1]

Pulmonary Hypertension1 trial

Pulmonary Embolism1 trial

Pulmonary Arterial Hypertension1 trial

Drug1 trial

Ischemia1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

Related News