hydroxyurea · Nova Labs Ltd · NDA 216593
Xromi
Earliest generic entry, as listed
23 Dec 2041
Blocked by patent: US 12409156.
Listed patents · 1 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 12409156 | drug product · sets the listed date | 23 Dec 2041 |
Exclusivities · 2 unexpired
| ODE-470 | orphan drug (7 years) | 4 Apr 2031 |
| NP | new product | 4 Apr 2027 |
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 |
|---|---|---|---|
| 216593 · 001 · RLD | solution, oral | 100MG/ML | 23 Dec 2041 |