drospirenone; estetrol · Mayne Pharma · NDA 214154
Nextstellis
Earliest generic entry, as listed
1 Oct 2043
Blocked by patent: US 12458649. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 7 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 12458649 | use U-3152 | 1 Oct 2043 |
| US 12233074 | product, use U-3152 | 9 Feb 2043 |
| US 11793760 | product | 17 Jun 2036 |
| US 11957694 | product | 17 Jun 2036 |
| US 11964055 | product | 17 Jun 2036 |
| US 12427114 | product, use U-3152 | 17 Jun 2036 |
| US 7732430 | product, use U-3152 | 15 Jan 2028 |
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 |
|---|---|---|---|
| 214154 · 001 · RLD | tablet, oral | 3MG;14.2MG | 1 Oct 2043 |
Expired or delisted (1)
- NCE · 15 Apr 2026