Orange Book product · Brand (NDA)
DROSPIRENONE
DROSPIRENONE
At a glance
Jun 29, 2022
Approved
Brand (NDA)
Application
Not listed
TE code
15
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 29, 2022
4 yr ago
Today
Patent 10179140 expires
Listed method-of-use patent (U-2553) expiration.
Jun 28, 2031
in 5 yr 1 mo
Patent 10603281 expires
Listed method-of-use patent (U-2553) expiration.
Jun 28, 2031
in 5 yr 1 mo
Patent 10849857 expires
Listed drug product patent expiration.
Jun 28, 2031
in 5 yr 1 mo
Patent 10987364 expires
Listed drug product patent expiration.
Jun 28, 2031
in 5 yr 1 mo
Patent 11123299 expires
Listed drug product patent expiration.
Jun 28, 2031
in 5 yr 1 mo
Patent 11291632 expires
Listed drug product patent expiration.
Jun 28, 2031
in 5 yr 1 mo
Patent 11291633 expires
Listed drug product patent expiration.
Jun 28, 2031
in 5 yr 1 mo
Patent 11351122 expires
Listed drug product patent expiration.
Jun 28, 2031
in 5 yr 1 mo
Patent 11413249 expires
Listed method-of-use patent (U-2553) expiration.
Jun 28, 2031
in 5 yr 1 mo
Patent 11439598 expires
Listed drug product patent expiration.
Jun 28, 2031
in 5 yr 1 mo
Patent 11478487 expires
Listed drug product patent expiration.
Jun 28, 2031
in 5 yr 1 mo
Patent 11504334 expires
Listed drug product patent expiration.
Jun 28, 2031
in 5 yr 1 mo
Patent 11951213 expires
Listed method-of-use patent (U-2553) expiration.
Jun 28, 2031
in 5 yr 1 mo
Patent 12090231 expires
Listed method-of-use patent (U-2553) expiration.
Jun 28, 2031
in 5 yr 1 mo
Patent 9603860 expires
Listed method-of-use patent (U-2553) expiration.
Jun 28, 2031
in 5 yr 1 mo
Pharmaceutical detail
Active ingredient
DROSPIRENONE
Strength
3.5MG
Dosage form
TABLET, CHEWABLE
Route
ORAL
TE code
Not listed
Application
NDA 216285
Product number
001
Marketing status
DISCN
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
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.
Listed patents (15)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10179140 | Jun 28, 2031 | in 5 yr 1 mo | U-2553 |
| 10603281 | Jun 28, 2031 | in 5 yr 1 mo | U-2553 |
| 10849857 | Jun 28, 2031 | in 5 yr 1 mo | ProductU-2553 |
| 10987364 | Jun 28, 2031 | in 5 yr 1 mo | Product |
| 11123299 | Jun 28, 2031 | in 5 yr 1 mo | Product |
| 11291632 | Jun 28, 2031 | in 5 yr 1 mo | Product |
| 11291633 | Jun 28, 2031 | in 5 yr 1 mo | Product |
| 11351122 | Jun 28, 2031 | in 5 yr 1 mo | Product |
| 11413249 | Jun 28, 2031 | in 5 yr 1 mo | U-2553 |
| 11439598 | Jun 28, 2031 | in 5 yr 1 mo | Product |
| 11478487 | Jun 28, 2031 | in 5 yr 1 mo | Product |
| 11504334 | Jun 28, 2031 | in 5 yr 1 mo | Product |
| 11951213 | Jun 28, 2031 | in 5 yr 1 mo | U-2553 |
| 12090231 | Jun 28, 2031 | in 5 yr 1 mo | U-2553 |
| 9603860 | Jun 28, 2031 | in 5 yr 1 mo | U-2553 |
