NDAVAGINALINSERT
Approved
Nov 2016
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
2
Mechanism of Action
12.1 Mechanism of Action Prasterone is an inactive endogenous steroid and is converted into active androgens and/or estrogens. The mechanism of action of INTRAROSA in postmenopausal women with vulvar and vaginal atrophy is not fully established. 12.3 Pharmacokinetics In a study conducted in…
Clinical Trials (2)
A Clinical Study of INTRAROSA® (Prasterone) Vaginal Inserts in Postmenopausal Vulvovaginal Atrophy
Started Sep 2021
417 enrolled
Postmenopausal Vulvovaginal Atrophy
Prasterone (Dehydroepiandrosterone) in Treating Postmenopausal Cancer Survivors With Vaginal Symptoms
Started Jul 2011
464 enrolled
Breast CancerGynecologic Cancer
Loss of Exclusivity
LOE Date
Mar 19, 2031
61 months away
Patent Expiry
Mar 19, 2031