NDAVAGINALINSERT
Approved
Nov 2016
Lifecycle
Peak
Competitive Pressure
8/100
Clinical Trials
2
Data completeness
6/8 — Strong
INTRAROSA (prasterone) by Millicent Pharma is 12. First approved in 2016.
Drug data last refreshed 9h ago · AI intelligence enriched 15h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
INTRAROSA (prasterone) is a vaginal insert approved in 2016 for postmenopausal women with vulvar and vaginal atrophy. Prasterone is an inactive endogenous steroid metabolized by steroidogenic enzymes into active androgens and estrogens locally at the vaginal site. The mechanism of action in treating vulvar and vaginal atrophy is not fully established, though local conversion to testosterone and estradiol is presumed therapeutic.
$0.037BPart D
Peak4.5 years to LOEProduct is at peak lifecycle with modest Part D utilization (122 claims in 2023), indicating stable but not rapidly expanding market penetration.
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…
Indications
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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.