FDA Orange Book
Generic for Alkeran
Alkeran 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
Yes. The generic name for Alkeran is melphalan. 12 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP. Generics match 1 of the 2 Alkeran products the Orange Book lists.
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Alkeran products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | EQ 50MG BASE/VIAL | Discontinued | None | 12 | AP |
| tablet, oral | 2MG | Discontinued | None | 0 | None |
NDA 020207, 014691, held by APOTEX INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic melphalan
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| MYLAN INSTITUTIONAL LLC | 090270 | AP (A-rated, therapeutically equivalent) | June 9, 2009 | EQ 50MG BASE/VIAL |
| HIKMA PHARMACEUTICALS USA INC | 090303 | AP (A-rated, therapeutically equivalent) | October 28, 2010 | EQ 50MG BASE/VIAL |
| ACTAVIS LLC | 206018 | AP (A-rated, therapeutically equivalent) | December 19, 2016 | EQ 50MG BASE/VIAL |
| SAGENT PHARMACEUTICALS INC | 201379 | AP (A-rated, therapeutically equivalent) | February 28, 2017 | EQ 50MG BASE/VIAL |
| DR REDDYS LABORATORIES LTD | 203655 | AP (A-rated, therapeutically equivalent) | December 8, 2017 | EQ 50MG BASE/VIAL |
| FRESENIUS KABI USA LLC | 203393 | AP (A-rated, therapeutically equivalent) | December 22, 2017 | EQ 50MG BASE/VIAL |
| GLAND PHARMA LTD | 209826 | AP (A-rated, therapeutically equivalent) | May 28, 2019 | EQ 50MG BASE/VIAL |
| QUAGEN PHARMACEUTICALS LLC | 211463 | AP (A-rated, therapeutically equivalent) | September 13, 2019 | EQ 50MG BASE/VIAL |
| BPI LABS LLC | 209197 | AP (A-rated, therapeutically equivalent) | May 8, 2020 | EQ 50MG BASE/VIAL |
| MEITHEAL PHARMACEUTICALS INC | 212960 | AP (A-rated, therapeutically equivalent) | May 28, 2021 | EQ 50MG BASE/VIAL |
| HETERO LABS LTD | 215024 | AP (A-rated, therapeutically equivalent) | May 23, 2024 | EQ 50MG BASE/VIAL |
| AVET LIFESCIENCES PRIVATE LTD | 206523 | AP (A-rated, therapeutically equivalent) | October 29, 2024 | EQ 50MG BASE/VIAL |
Questions
Is there a generic for Alkeran?
Yes. The generic name for Alkeran is melphalan. 12 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP. Generics match 1 of the 2 Alkeran products the Orange Book lists.
What is the generic name for Alkeran?
The active ingredient in Alkeran is melphalan, per the FDA Orange Book.
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.