panobinostat lactate · Secura · NDA 205353
Farydak
Earliest generic entry, as listed · earliest of 3 marketed strengths
13 Jun 2028
No marketed reference-listed strength; date taken from all listed strengths.
Blocked by patent: US 8883842. 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 8883842 | use U-1669 · sets the listed date | 13 Jun 2028 |
| US 7989494 | drug substance, drug product | 17 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 · 3
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 205353 · 001 · RLD · discontinued | capsule, oral | EQ 10MG BASE | 13 Jun 2028 |
| 205353 · 002 · RLD · discontinued | capsule, oral | EQ 15MG BASE | 13 Jun 2028 |
| 205353 · 003 · RLD · discontinued | capsule, oral | EQ 20MG BASE | 13 Jun 2028 |