FDA Orange Book
Generic for Exjade
Exjade contains deferasirox. 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 Exjade is deferasirox. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Exjade products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, for suspension, oral | 125MG | Marketed (Rx) | AB | 8 | AB |
| tablet, for suspension, oral | 250MG | Marketed (Rx) | AB | 8 | AB |
| tablet, for suspension, oral | 500MG | Marketed (Rx) | AB | 8 | AB |
NDA 021882, held by NOVARTIS PHARMACEUTICALS CORP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic deferasirox
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ACTAVIS ELIZABETH LLC | 203560 | AB (A-rated, therapeutically equivalent) | January 26, 2016 | 125MG, 250MG, 500MG |
| ALEMBIC PHARMACEUTICALS LTD | 210060 | AB (A-rated, therapeutically equivalent) | November 20, 2019 | 125MG, 250MG, 500MG |
| ALKEM LABORATORIES LTD | 210519 | AB (A-rated, therapeutically equivalent) | November 20, 2019 | 125MG, 250MG, 500MG |
| BIONPHARMA INC | 210920 | AB (A-rated, therapeutically equivalent) | November 20, 2019 | 125MG, 250MG, 500MG |
| MSN LABORATORIES PRIVATE LTD | 209878 | AB (A-rated, therapeutically equivalent) | November 20, 2019 | 125MG, 250MG, 500MG |
| SUN PHARMACEUTICAL INDUSTRIES LTD | 209782 | AB (A-rated, therapeutically equivalent) | November 20, 2019 | 125MG, 250MG, 500MG |
| GLENMARK SPECIALTY SA | 209433 | AB (A-rated, therapeutically equivalent) | January 6, 2020 | 125MG, 250MG, 500MG |
| TEVA PHARMACEUTICALS USA INC | 207124 | AB (A-rated, therapeutically equivalent) | September 23, 2022 | 125MG, 250MG, 500MG |
Exjade NDC codes
Questions
Is there a generic for Exjade?
Yes. The generic name for Exjade is deferasirox. 8 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
What is the generic name for Exjade?
The active ingredient in Exjade is deferasirox, 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.