givinostat hydrochloride · Italfarmaco Spa · NDA 217865
Duvyzat
Earliest generic entry, as listed
3 May 2040
Blocked by patent: US 12606519.
Listed patents · 5 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 12606519 | drug substance, drug product · sets the listed date | 3 May 2040 |
| US 10688047 | drug product, use U-3885 | 28 Oct 2036 |
| US 9421184 | use U-3885 | 3 Feb 2032 |
| US 9867799 | use U-3885 | 3 Feb 2032 |
| US 7329689 | drug substance, drug product | 15 Jan 2027 |
Exclusivities · 2 unexpired
| ODE-473 | orphan drug (7 years) | 21 Mar 2031 |
| NCE | new chemical entity (5 years) | 21 Mar 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 |
|---|---|---|---|
| 217865 · 001 · RLD | suspension, oral | EQ 8.86MG BASE/ML | 3 May 2040 |