FDA Orange Book
Generic for Jadenu
Jadenu 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 Jadenu is deferasirox. 11 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AB.
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Jadenu products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 180MG | Marketed (Rx) | AB | 11 | AB |
| tablet, oral | 360MG | Marketed (Rx) | AB | 11 | AB |
| tablet, oral | 90MG | Marketed (Rx) | AB | 11 | AB |
NDA 206910, 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 | 208697 | AB (A-rated, therapeutically equivalent) | December 13, 2019 | 180MG, 360MG, 90MG |
| ALEMBIC PHARMACEUTICALS LTD | 211824 | AB (A-rated, therapeutically equivalent) | June 15, 2020 | 180MG, 360MG, 90MG |
| PIRAMAL HEALTHCARE UK LTD | 212995 | AB (A-rated, therapeutically equivalent) | June 15, 2020 | 180MG, 360MG, 90MG |
| ZYDUS PHARMACEUTICALS USA INC | 211383 | AB (A-rated, therapeutically equivalent) | June 15, 2020 | 180MG, 360MG, 90MG |
| MSN LABORATORIES PRIVATE LTD | 210945 | AB (A-rated, therapeutically equivalent) | June 16, 2020 | 180MG, 360MG, 90MG |
| ALKEM LABORATORIES LTD | 210555 | AB (A-rated, therapeutically equivalent) | July 2, 2020 | 180MG, 360MG, 90MG |
| ANNORA PHARMA PRIVATE LTD | 214341 | AB (A-rated, therapeutically equivalent) | May 14, 2021 | 180MG, 360MG, 90MG |
| CHARTWELL RX SCIENCES LLC | 212669 | AB (A-rated, therapeutically equivalent) | May 27, 2021 | 180MG, 360MG, 90MG |
| AUROBINDO PHARMA LTD | 214474 | AB (A-rated, therapeutically equivalent) | October 16, 2023 | 180MG, 360MG, 90MG |
| PHARMOBEDIENT CONSULTING LLC | 211395 | AB (A-rated, therapeutically equivalent) | March 22, 2024 | 180MG, 360MG, 90MG |
| JUBILANT GENERICS LTD | 211660 | AB (A-rated, therapeutically equivalent) | April 11, 2025 | 180MG, 360MG, 90MG |
Jadenu patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9283209 | November 21, 2034 | Drug substance, Drug product | None | 206910 |
Jadenu NDC codes
Questions
Is there a generic for Jadenu?
Yes. The generic name for Jadenu is deferasirox. 11 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 Jadenu?
The active ingredient in Jadenu is deferasirox, per the FDA Orange Book.
When does the Jadenu patent expire?
The last patent listed for Jadenu in the Orange Book expires November 21, 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.