FDA Orange Book
Is there a generic for Hepzato?
Hepzato contains melphalan. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
No. The Orange Book lists no active FDA-approved generic (ANDA) for Hepzato (melphalan). The Orange Book shows its last listed patent expires September 17, 2034 and its last listed exclusivity ends August 14, 2030.
Run it in Rivvi
Map Hepzato and your other top fills to their generics
Every strength in RxNorm, with brands that have no generic flagged.
Build the mapFree to start. Opens Rivvi, the AI workspace for healthcare teams.
Hepzato products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| powder, intra-arterial | EQ 50MG BASE/VIAL | Marketed (Rx) | None | 0 | None |
NDA 201848, held by DELCATH SYSTEMS INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Hepzato patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 11633528 | November 7, 2032 | Method of use | U-3675 | 201848 |
| 10569004 | November 7, 2032 | Method of use | U-3680 | 201848 |
| 10569004 | November 7, 2032 | Method of use | U-3683 | 201848 |
| 10369264 | November 7, 2032 | Drug product | None | 201848 |
| 10098997 | November 7, 2032 | Drug product | None | 201848 |
| 11241522 | November 7, 2032 | Drug product | None | 201848 |
| 11833286 | December 30, 2032 | Drug product | None | 201848 |
| 11083831 | December 30, 2032 | Drug product | None | 201848 |
| 10195334 | January 16, 2033 | Drug product | None | 201848 |
| 9314561 | February 7, 2034 | Drug product | None | 201848 |
| 9707331 | September 17, 2034 | Drug product | None | 201848 |
Hepzato exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NP | New product | August 14, 2026 | 201848 |
| ODE-438 | Orphan drug exclusivity | August 14, 2030 | 201848 |
Questions
Is there a generic for Hepzato?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Hepzato (melphalan). The Orange Book shows its last listed patent expires September 17, 2034 and its last listed exclusivity ends August 14, 2030.
What is the generic name for Hepzato?
The active ingredient in Hepzato is melphalan, per the FDA Orange Book.
When does the Hepzato patent expire?
The last patent listed for Hepzato in the Orange Book expires September 17, 2034. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.