FDA Orange Book · active-ingredient family
Drospirenone
Drospirenone is approved in 2 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:DROSPIRENONE · NDA 216285
2
Brand (NDA)
0
Generics (ANDA)
16
Listed patents
0
Exclusivity periods
Brand (NDA) products · tablet, tablet, chewable
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DROSPIRENONERLD | EXELTIS USA INC | NDA 216285 | — | Jun 29, 2022 | |
| SLYNDRLD | EXELTIS USA INC | NDA 211367 | — | May 23, 2019 |
Listed patents (16)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10603281 | Jun 28, 2031 | in 5 yr 1 mo | U-2553 |
| 10849857 | Jun 28, 2031 | in 5 yr 1 mo | ProductU-2553 |
| 12090231 | Jun 28, 2031 | in 5 yr 1 mo | U-2553 |
| 9603860 | Jun 28, 2031 | in 5 yr 1 mo | U-2553 |
| 10179140 | Jun 28, 2031 | in 5 yr 1 mo | U-2553 |
| 11413249 | Jun 28, 2031 | in 5 yr 1 mo | U-2553 |
| 11951213 | Jun 28, 2031 | in 5 yr 1 mo | U-2553 |
| 11351122 | Jun 28, 2031 | in 5 yr 1 mo | Product |
| 11123299 | Jun 28, 2031 | in 5 yr 1 mo | Product |
| 11439598 | Jun 28, 2031 | in 5 yr 1 mo | Product |
| 11291633 | Jun 28, 2031 | in 5 yr 1 mo | Product |
| 10987364 | Jun 28, 2031 | in 5 yr 1 mo | Product |
| 11291632 | Jun 28, 2031 | in 5 yr 1 mo | Product |
| 11504334 | Jun 28, 2031 | in 5 yr 1 mo | Product |
| 11478487 | Jun 28, 2031 | in 5 yr 1 mo | Product |
| 12280151 | Jun 28, 2031 | in 5 yr 1 mo | Product |
Drospirenone — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
