Prescription medicine
Prasterone Brand names: Intrarosa
Prasterone (Intrarosa) is a prescription medicine with an FDA approval on record since 2016. No generic is listed; pharmacies paid $10.98 per unit (Intrarosa 6.5 mg vag insert) in the October 7, 2026 NADAC survey.
- No generic listed
Check it at the source: the prasterone FDA label on DailyMed (effective July 17, 2026, Millicent US, Inc.); the NDA 208470 record on Drugs@FDA; every prasterone label on DailyMed.
Highlights of the record
FDA label of July 17, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usageINTRAROSA ® is a steroid indicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause.
Forms and strengths
- 6.5 mg
Insert.
On the market
- Earliest approval on file
- November 16, 2016 Intrarosa, Millicent; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- March 19, 2031 Intrarosa insert; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $10.98 per unit Intrarosa 6.5 mg vag insert
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 2,672 through July 30, 2026
What is prasterone used for?
From the label: indications and usageINTRAROSA ® is a steroid indicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause. INTRAROSA ® is a steroid indicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause.
Conditions named in the indications of prasterone's FDA labels, with every medicine labeled for each:
Source: FDA drug label (Intrarosa), Millicent US, Inc., effective July 17, 2026 (SPL set ada639d4-bac0-2ad0-e053-2a95a90afce7), via openFDA; the full label on DailyMed
Is there a generic for prasterone (Intrarosa)?
No generic prasterone is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 3 patents for Intrarosa insert, the last expiring on March 19, 2031. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2016 earliest approval on file
- 2031 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for prasterone (Intrarosa)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $10.98 per unit (Intrarosa 6.5 mg vag insert), up 9% from $10.08 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Intrarosa 6.5 mg vag insert (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Intrarosa 6.5 mg vag insert | Brand | $10.98 per unit | n/a | +9% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What do FAERS reports show for prasterone?
The FDA Adverse Event Reporting System holds 2,672 reports that list prasterone among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 46 are coded as a death and 275 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Prasterone side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other