melphalan hydrochloride · Delcath Systems Inc · NDA 201848
Hepzato
Earliest generic entry, as listed
17 Sep 2034
Blocked by patent: US 9707331.
Listed patents · 10 unexpired
11 Orange Book listing rows for 10 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 9707331 | drug product · sets the listed date | 17 Sep 2034 |
| US 9314561 | drug product | 7 Feb 2034 |
| US 10195334 | drug product | 16 Jan 2033 |
| US 11083831 | drug product | 30 Dec 2032 |
| US 11833286 | drug product | 30 Dec 2032 |
| US 10098997 | drug product | 7 Nov 2032 |
| US 10369264 | drug product | 7 Nov 2032 |
| US 10569004 | use U-3680, U-3683 | 7 Nov 2032 |
| US 10569004 listing row | use U-3680 | 7 Nov 2032 |
| US 10569004 listing row | use U-3683 | 7 Nov 2032 |
| US 11241522 | drug product | 7 Nov 2032 |
| US 11633528 | use U-3675 | 7 Nov 2032 |
Exclusivities · 1 unexpired
| ODE-438 | orphan drug (7 years) | 14 Aug 2030 |
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 |
|---|---|---|---|
| 201848 · 001 · RLD | powder, intra-arterial | EQ 50MG BASE/VIAL | 17 Sep 2034 |
Expired or delisted (1)
- NP · 14 Aug 2026