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 1h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
INTRAROSA (prasterone) is a vaginal insert approved in 2016 for treating vulvar and vaginal atrophy in postmenopausal women. The drug is an inactive endogenous steroid converted locally into active androgens and estrogens via tissue steroidogenic enzymes. Mechanism of action in atrophy is not fully established, but systemic exposure to testosterone and estradiol metabolites is modest and localized vaginal effects are presumed therapeutic.
$0.037BPart D
Peak4.7 years to LOEProduct is in peak lifecycle with modest Part D utilization; established brand teams managing stable but niche indication suggests selective expansion opportunities rather than rapid growth.
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.