FDA Orange Book · active-ingredient family
Deferasirox
Deferasirox is approved as 3 brand and 35 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:JADENU SPRINKLE · NDA 207968
3
Brand (NDA)
35
Generics (ANDA)
1
Listed patents
0
Exclusivity periods
Brand (NDA) products · granule, tablet, tablet, for suspension
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| JADENU SPRINKLERLD×3 | NOVARTIS | NDA 207968 | AB | May 18, 2017 | |
| JADENURLD×3 | NOVARTIS PHARMS CORP | NDA 206910 | AB | Mar 30, 2015 | |
| EXJADERLD×3 | NOVARTIS | NDA 021882 | AB | Nov 02, 2005 |
Generic (ANDA) products (35)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DEFERASIROX×3 | AUROBINDO PHARMA | ANDA 215137 | AB | Sep 08, 2025 | |
| DEFERASIROX×3 | JUBILANT GENERICS | ANDA 211660 | AB | Apr 11, 2025 | |
| DEFERASIROX×3 | TORRENT | ANDA 209426 | — | Nov 05, 2024 | |
| DEFERASIROX×3 | PHARMOBEDIENT | ANDA 206585 | — | May 17, 2024 | |
| DEFERASIROX×3 | PHARMOBEDIENT | ANDA 213146 | — | May 03, 2024 | |
| DEFERASIROX×3 | PHARMOBEDIENT | ANDA 211395 | AB | Mar 22, 2024 | |
| DEFERASIROX×3 | AUROBINDO PHARMA LTD | ANDA 214474 | AB | Oct 16, 2023 | |
| DEFERASIROX×3 | ANNORA PHARMA | ANDA 216229 | AB | Mar 16, 2023 | |
| DEFERASIROX×3 | TEVA PHARMS USA | ANDA 207124 | AB | Sep 23, 2022 | |
| DEFERASIROX×3 | MSN | ANDA 214650 | AB | Apr 20, 2022 | |
| DEFERASIROX×3 | CIPLA | ANDA 215026 | AB | Feb 23, 2022 | |
| DEFERASIROX×3 | TEVA PHARMS USA | ANDA 214180 | — | Nov 19, 2021 | |
| DEFERASIROX×3 | AMNEAL | ANDA 214194 | — | Aug 02, 2021 | |
| DEFERASIROX×3 | CHARTWELL RX | ANDA 212669 | AB | May 27, 2021 | |
| DEFERASIROX×3 | ANNORA PHARMA | ANDA 214341 | AB | May 14, 2021 | |
| DEFERASIROX×3 | AUCTA | ANDA 214559 | AB | Mar 09, 2021 | |
| DEFERASIROX×3 | ALKEM LABS LTD | ANDA 213374 | AB | Jul 14, 2020 | |
| DEFERASIROX×3 | ZYDUS PHARMS | ANDA 208882 | — | May 05, 2020 | |
| DEFERASIROX×3 | ALKEM LABS LTD | ANDA 210555 | AB | Mar 30, 2020 | |
| DEFERASIROX×3 | CIPLA | ANDA 211852 | — | Feb 11, 2020 | |
| DEFERASIROX×3 | GLENMARK SPECLT | ANDA 209433 | AB | Jan 06, 2020 | |
| DEFERASIROX×3 | SUN PHARM | ANDA 211641 | — | Jan 02, 2020 | |
| DEFERASIROX×3 | PIRAMAL | ANDA 212995 | AB | Dec 30, 2019 | |
| DEFERASIROX×3 | STEVENS J | ANDA 210727 | — | Dec 27, 2019 | |
| DEFERASIROX×3 | ACTAVIS ELIZABETH | ANDA 208697 | AB | Dec 13, 2019 | |
| DEFERASIROX×3 | TEVA PHARMS USA | ANDA 209223 | — | Nov 25, 2019 | |
| DEFERASIROX×3 | ALEMBIC | ANDA 210060 | AB | Nov 20, 2019 | |
| DEFERASIROX×3 | ALKEM LABS LTD | ANDA 210519 | AB | Nov 20, 2019 | |
| DEFERASIROX×3 | BIONPHARMA | ANDA 210920 | AB | Nov 20, 2019 | |
| DEFERASIROX×3 | MSN | ANDA 209878 | AB | Nov 20, 2019 | |
| DEFERASIROX×3 | SUN PHARM | ANDA 209782 | AB | Nov 20, 2019 | |
| DEFERASIROX×3 | ALEMBIC | ANDA 211824 | AB | Nov 20, 2019 | |
| DEFERASIROX×3 | MSN | ANDA 210945 | AB | Nov 20, 2019 | |
| DEFERASIROX×3 | ZYDUS PHARMS | ANDA 211383 | AB | Nov 20, 2019 | |
| DEFERASIROX×3 | ACTAVIS ELIZABETH | ANDA 203560 | AB | Jan 26, 2016 |
Listed patents (1)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9283209 | Nov 21, 2034 | in 8 yr 7 mo | SubstanceProduct |
Deferasirox — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
