FDA Orange Book
Generic for Velcade
Velcade contains bortezomib. 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 Velcade is bortezomib. 15 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
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Velcade products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, intravenous, subcutaneous | 3.5MG/VIAL | Marketed (Rx) | AP | 15 | AP |
NDA 021602, held by TAKEDA PHARMACEUTICALS USA INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic bortezomib
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| APOTEX INC | 205533 | AP (A-rated, therapeutically equivalent) | May 2, 2022 | 3.5MG/VIAL |
| EUGIA PHARMA SPECIALITIES LTD | 212825 | AP (A-rated, therapeutically equivalent) | May 2, 2022 | 3.5MG/VIAL |
| FRESENIUS KABI USA LLC | 209659 | AP (A-rated, therapeutically equivalent) | May 2, 2022 | 3.5MG/VIAL |
| PHARMASCIENCE INC | 208392 | AP (A-rated, therapeutically equivalent) | May 2, 2022 | 3.5MG/VIAL |
| QILU PHARMACEUTICAL HAINAN CO LTD | 210824 | AP (A-rated, therapeutically equivalent) | May 2, 2022 | 3.5MG/VIAL |
| ZYDUS PHARMACEUTICALS USA INC | 210204 | AP (A-rated, therapeutically equivalent) | May 2, 2022 | 3.5MG/VIAL |
| DR REDDYS LABORATORIES LTD | 202963 | AP (A-rated, therapeutically equivalent) | July 26, 2022 | 3.5MG/VIAL |
| HOSPIRA INC | 208460 | AP (A-rated, therapeutically equivalent) | July 26, 2022 | 3.5MG/VIAL |
| JIANGSU HANSOH PHARMACEUTICAL GROUP CO LTD | 215011 | AP (A-rated, therapeutically equivalent) | July 26, 2022 | 3.5MG/VIAL |
| MEITHEAL PHARMACEUTICALS INC | 212958 | AP (A-rated, therapeutically equivalent) | July 26, 2022 | 3.5MG/VIAL |
| MSN LABORATORIES PRIVATE LTD | 209622 | AP (A-rated, therapeutically equivalent) | July 26, 2022 | 3.5MG/VIAL |
| SOMERSET THERAPEUTICS LLC | 211898 | AP (A-rated, therapeutically equivalent) | October 11, 2022 | 3.5MG/VIAL |
| HETERO LABS LTD UNIT VI | 212204 | AP (A-rated, therapeutically equivalent) | May 3, 2024 | 3.5MG/VIAL |
| VILIN BIO MED LTD | 218688 | AP (A-rated, therapeutically equivalent) | June 2, 2025 | 3.5MG/VIAL |
| HAINAN SHUANGCHENG PHARMACEUTICALS CO LTD | 216528 | AP (A-rated, therapeutically equivalent) | December 17, 2025 | 3.5MG/VIAL |
Velcade NDC codes
Questions
Is there a generic for Velcade?
Yes. The generic name for Velcade is bortezomib. 15 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
What is the generic name for Velcade?
The active ingredient in Velcade is bortezomib, 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.