drospirenone · Exeltis Usa Inc · NDA 216285
Drospirenone
Earliest generic entry, as listed
28 Jun 2031
No marketed reference-listed strength; date taken from all listed strengths.
Blocked by patent: US 10179140, US 10603281, US 10849857, US 10987364, US 11123299, US 11291632, US 11291633, US 11351122, US 11413249, US 11439598, US 11478487, US 11504334, US 11951213, US 12090231, US 9603860.
Listed patents · 15 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 10179140 | use U-2553 · sets the listed date | 28 Jun 2031 |
| US 10603281 | use U-2553 · sets the listed date | 28 Jun 2031 |
| US 10849857 | drug product, use U-2553 · sets the listed date | 28 Jun 2031 |
| US 10987364 | drug product · sets the listed date | 28 Jun 2031 |
| US 11123299 | drug product · sets the listed date | 28 Jun 2031 |
| US 11291632 | drug product · sets the listed date | 28 Jun 2031 |
| US 11291633 | drug product · sets the listed date | 28 Jun 2031 |
| US 11351122 | drug product · sets the listed date | 28 Jun 2031 |
| US 11413249 | use U-2553 · sets the listed date | 28 Jun 2031 |
| US 11439598 | drug product · sets the listed date | 28 Jun 2031 |
| US 11478487 | drug product · sets the listed date | 28 Jun 2031 |
| US 11504334 | drug product · sets the listed date | 28 Jun 2031 |
| US 11951213 | use U-2553 · sets the listed date | 28 Jun 2031 |
| US 12090231 | use U-2553 · sets the listed date | 28 Jun 2031 |
| US 9603860 | use U-2553 · sets the listed date | 28 Jun 2031 |
Exclusivities · 0 unexpired
No unexpired exclusivities listed.
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.
Products covered · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 216285 · 001 · RLD · discontinued | tablet, chewable, oral | 3.5MG | 28 Jun 2031 |