FDA Orange Book · active-ingredient family
Prasterone
Prasterone is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:INTRAROSA · NDA 208470
1
Brand (NDA)
0
Generics (ANDA)
3
Listed patents
0
Exclusivity periods
Brand (NDA) products · insert
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| INTRAROSARLD | MILLICENT | NDA 208470 | — | Nov 16, 2016 |
Listed patents (3)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8629129 | Aug 07, 2028 | in 2 yr 2 mo | Product |
| 8957054 | Jan 08, 2030 | in 3 yr 7 mo | U-1922 |
| 8268806 | Mar 19, 2031 | in 4 yr 10 mo | Product |
Prasterone — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
