NDAORALTABLETPriority Review
Approved
Mar 1998
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
Priority Review
VIAGRA (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 1998.
Drug data last refreshed 10h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
VIAGRA (sildenafil citrate) is an oral small-molecule phosphodiesterase-5 (PDE-5) inhibitor approved in 1998 for erectile dysfunction and pulmonary arterial hypertension. It works by inhibiting PDE-5 in smooth muscle, increasing cGMP levels and promoting vasodilation in the pulmonary and peripheral vasculature. The drug's high selectivity for PDE-5 (approximately 4,000-fold over PDE-3) minimizes cardiac contractility effects while maintaining efficacy.
$0.334MPart D
LOE ApproachingProduct approaching loss of exclusivity with competitive pressure intensifying; brand team focus shifting toward lifecycle management and generic transition planning.
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 (20)
Sildenafil 100 mg Tablets Relative to Viagra 100 mg Tablets
Started Feb 2025
36 enrolled
Healthy Subjects
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
Pharmacokinetics of Sildenafil Following Administration of an Chewable Tablet of Sildenafil Relative to Viagra® Conventional Oral Tablet in Healthy Volunteers
Started Dec 2011
54 enrolled
Erectile Dysfunction
Study of Sildenafil Citrate on Insulin Resistance in African American
Started Apr 2011
46 enrolled
Metabolic SyndromeObesity
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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.