NDAORALTABLETPriority Review
Approved
Jun 2005
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
11
Clinical Trials (5)
A Bioequivalence Study of Sildenafil Citrate Orally-Disintegrating Film Dosage Form
Started Jan 2021
0Healthy
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
A Relative Bioavailability Study of Revatio for the Crushed Tablets, Extemporaneously Prepared Formulation, and the Intact Tablets at 20 mg Dose in Healthy Volunteers
Started Sep 2009
18 enrolled
Healthy
Loss of Exclusivity
LOE Date
Jan 31, 2030
47 months away
Exclusivity Expiry
Jan 31, 2030