clindamycin phosphate · Organon Llc · NDA 215650
Xaciato
Earliest generic entry, as listed
22 Sep 2036
Blocked by patent: US 11129896, US 12303563.
Listed patents · 2 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 11129896 | use U-3293 · sets the listed date | 22 Sep 2036 |
| US 12303563 | drug product · sets the listed date | 22 Sep 2036 |
Exclusivities · 1 unexpired
| GAIN | qualified infectious disease product | 7 Dec 2029 |
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 |
|---|---|---|---|
| 215650 · 001 · RLD | gel, vaginal | EQ 2% BASE | 22 Sep 2036 |
Expired or delisted (1)
- NP · 7 Dec 2024