FDA Orange Book
Is there a generic for Ivra?
Ivra 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 Ivra (melphalan). The Orange Book shows its last listed patent expires June 29, 2036.
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Ivra products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, intravenous | EQ 90MG BASE/ML (EQ 90MG BASE/ML) | Marketed (Rx) | None | 0 | None |
NDA 217110, held by APOTEX INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Ivra patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 10537520 | June 29, 2036 | Drug product | None | 217110 |
Ivra NDC codes
Questions
Is there a generic for Ivra?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Ivra (melphalan). The Orange Book shows its last listed patent expires June 29, 2036.
What is the generic name for Ivra?
The active ingredient in Ivra is melphalan, per the FDA Orange Book.
When does the Ivra patent expire?
The last patent listed for Ivra in the Orange Book expires June 29, 2036. 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.