FDA Orange Book
Is there a generic for Evomela?
Evomela 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 Evomela (melphalan). The Orange Book shows its last listed patent expires January 30, 2034.
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Evomela products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| powder, intravenous | EQ 50MG BASE/VIAL | Marketed (Rx) | None | 0 | None |
NDA 207155, held by ACROTECH BIOPHARMA INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Evomela patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9200088 | March 13, 2029 | Drug product | None | 207155 |
| 8410077 | March 13, 2029 | Drug product | None | 207155 |
| 11020363 | May 28, 2030 | Drug product | None | 207155 |
| 10864183 | May 28, 2030 | Drug product | None | 207155 |
| 10940128 | June 14, 2030 | Drug product | U-3086 | 207155 |
| 9493582 | February 27, 2033 | Drug product | None | 207155 |
| 10040872 | January 30, 2034 | Drug product | None | 207155 |
Evomela NDC codes
Questions
Is there a generic for Evomela?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Evomela (melphalan). The Orange Book shows its last listed patent expires January 30, 2034.
What is the generic name for Evomela?
The active ingredient in Evomela is melphalan, per the FDA Orange Book.
When does the Evomela patent expire?
The last patent listed for Evomela in the Orange Book expires January 30, 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.