NDAINTRAVENOUSSOLUTION
Approved
Nov 2009
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
13
Data completeness
4/8 — Partial
REVATIO (sildenafil citrate) by Viatris (2) is pde-5 in the smooth muscle of the pulmonary vasculature, where pde-5 is responsible for degradation of cgmp. First approved in 2009.
Drug data last refreshed 19h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
REVATIO (sildenafil citrate) is a PDE-5 inhibitor administered intravenously that treats pulmonary arterial hypertension (PAH) by increasing cGMP levels in pulmonary vascular smooth muscle, causing vasodilation. The drug selectively inhibits PDE-5 with approximately 4,000-fold selectivity over PDE-3, avoiding cardiac contractility effects while maintaining pulmonary specificity.
$8MPart D
LOE ApproachingPost-LOECommercial lifecycle is contracting toward loss of exclusivity (January 2026), suggesting brand team focus will shift from growth to retention and managed transition.
Mechanism of Action
PDE-5 in the smooth muscle of the pulmonary vasculature, where PDE-5 is responsible for degradation of cGMP. Sildenafil, therefore, increases cGMP within pulmonary vascular smooth muscle cells resulting in relaxation. In patients with PAH, this can lead to vasodilation of the pulmonary vascular bed…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (13)
A Bioequivalence Study of Sildenafil Citrate Orally-Disintegrating Film Dosage Form
Started Jan 2021
0Healthy
Drug-Drug Interaction of Clomipramine HCl and Sildenafil Citrate in Healthy Males
Started Jan 2014
30 enrolled
Healthy
Study of Sildenafil Citrate on Insulin Resistance in African American
Started Apr 2011
46 enrolled
Metabolic SyndromeObesity
A Pivotal Bioequivalence Study Between The Sildenafil Powder For Oral Suspension (10 Mg/Ml) And The Sildenafil 10 Mg Immediate Release (IR) Tablet Relative To The Revatio 20 Mg IR Tablet In Healthy Volunteers Under Fasting Conditions
Started Jan 2011
42 enrolled
Pulmonary Arterial Hypertention
A Relative Bioavailability Study Between Two Formulations Of Sildenafil Citrate
Started Jan 2010
47 enrolled
Erectile Dysfunction
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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.