Orange Book product · Brand (NDA)
NEXTSTELLIS
DROSPIRENONE; ESTETROL
At a glance
Apr 15, 2021
Approved
Brand (NDA)
Application
Not listed
TE code
7
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 15, 2021
5 yr 3 mo ago
Exclusivity ends · NCE
New chemical entity exclusivity (5 years)
Apr 15, 2026
2 mo ago
Today
Patent 7732430 expires
Listed drug product patent expiration.
Jan 15, 2028
in 1 yr 7 mo
Patent 11793760 expires
Listed drug product patent expiration.
Jun 17, 2036
in 10 yr 2 mo
Patent 11957694 expires
Listed drug product patent expiration.
Jun 17, 2036
in 10 yr 2 mo
Patent 11964055 expires
Listed drug product patent expiration.
Jun 17, 2036
in 10 yr 2 mo
Patent 12427114 expires
Listed drug product patent expiration.
Jun 17, 2036
in 10 yr 2 mo
Patent 12233074 expires
Listed drug product patent expiration.
Feb 09, 2043
in 16 yr 11 mo
Patent 12458649 expires
Listed method-of-use patent (U-3152) expiration.
Oct 01, 2043
in 17 yr 6 mo
Pharmaceutical detail
Active ingredient
DROSPIRENONE; ESTETROL
Strength
3MG;14.2MG
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 214154
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Marketing exclusivity (1)
- NCENew chemical entity exclusivity (5 years)
Apr 15, 2026
2 mo ago
Listed patents (7)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7732430 | Jan 15, 2028 | in 1 yr 7 mo | ProductU-3152 |
| 11793760 | Jun 17, 2036 | in 10 yr 2 mo | Product |
| 11957694 | Jun 17, 2036 | in 10 yr 2 mo | Product |
| 11964055 | Jun 17, 2036 | in 10 yr 2 mo | Product |
| 12427114 | Jun 17, 2036 | in 10 yr 2 mo | ProductU-3152 |
| 12233074 | Feb 09, 2043 | in 16 yr 11 mo | ProductU-3152 |
| 12458649 | Oct 01, 2043 | in 17 yr 6 mo | U-3152 |
