vorinostat · Msd Sub Merck · NDA 021991
Zolinza
Earliest generic entry, as listed
18 Mar 2028
Blocked by patent: US 8450372. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 2 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 8450372 | use U-892 · sets the listed date | 18 Mar 2028 |
| US 7456219 | drug substance | 11 Mar 2027 |
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 |
|---|---|---|---|
| 021991 · 001 · RLD | capsule, oral | 100MG | 18 Mar 2028 |
Expired or delisted (1)
- US 8093295 · product · 16 May 2026