FDA Orange Book · active-ingredient family
Deferasirox
Deferasirox: 3 brands, 35 generics; first approved Nov 02, 2005; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 35 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
3
Generics (ANDA)
35
Listed patents
1
Next patent expiry
Nov 21, 2034
in 8 yr 5 mo
Brand (NDA) products
Originator applications
- NOVARTISNDA 20796820173 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 90MG GRANULE ORAL Rx AB 180MG GRANULE ORAL Rx AB 360MG GRANULE ORAL Rx AB - JADENURLDNOVARTIS PHARMS CORPNDA 20691020153 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 90MG TABLET ORAL Rx AB 180MG TABLET ORAL Rx AB 360MG TABLET ORAL Rx AB - EXJADERLDNOVARTISNDA 02188220053 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 125MG TABLET, FOR SUSPENSION ORAL Rx AB 250MG TABLET, FOR SUSPENSION ORAL Rx AB 500MG TABLET, FOR SUSPENSION ORAL Rx AB
Generic (ANDA) products (35)
Abbreviated applications
- DEFERASIROXAUROBINDO PHARMAANDA 21513720253 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 90MG GRANULE ORAL Rx AB 180MG GRANULE ORAL Rx AB 360MG GRANULE ORAL Rx AB - DEFERASIROXJUBILANT GENERICSANDA 21166020253 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 90MG TABLET ORAL Rx AB 180MG TABLET ORAL Rx AB 360MG TABLET ORAL Rx AB - DEFERASIROXTORRENTANDA 20942620243 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 125MG TABLET, FOR SUSPENSION ORAL Discontinued — 250MG TABLET, FOR SUSPENSION ORAL Discontinued — 500MG TABLET, FOR SUSPENSION ORAL Discontinued — - DEFERASIROXPHARMOBEDIENTANDA 20658520243 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 125MG TABLET, FOR SUSPENSION ORAL Discontinued — 250MG TABLET, FOR SUSPENSION ORAL Discontinued — 500MG TABLET, FOR SUSPENSION ORAL Discontinued — - DEFERASIROXPHARMOBEDIENTANDA 21314620243 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 90MG GRANULE ORAL Discontinued — 180MG GRANULE ORAL Discontinued — 360MG GRANULE ORAL Discontinued — - DEFERASIROXPHARMOBEDIENTANDA 21139520243 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 90MG TABLET ORAL Rx AB 180MG TABLET ORAL Rx AB 360MG TABLET ORAL Rx AB - DEFERASIROXAUROBINDO PHARMA LTDANDA 21447420233 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 90MG TABLET ORAL Rx AB 180MG TABLET ORAL Rx AB 360MG TABLET ORAL Rx AB - DEFERASIROXANNORA PHARMAANDA 21622920233 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 180MG GRANULE ORAL Rx AB 360MG GRANULE ORAL Rx AB 90MG GRANULE ORAL Rx AB - DEFERASIROXTEVA PHARMS USAANDA 20712420223 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 125MG TABLET, FOR SUSPENSION ORAL Rx AB 250MG TABLET, FOR SUSPENSION ORAL Rx AB 500MG TABLET, FOR SUSPENSION ORAL Rx AB - DEFERASIROXMSNANDA 21465020223 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 180MG GRANULE ORAL Rx AB 360MG GRANULE ORAL Rx AB 90MG GRANULE ORAL Rx AB - DEFERASIROXCIPLAANDA 21502620223 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 90MG GRANULE ORAL Rx AB 180MG GRANULE ORAL Rx AB 360MG GRANULE ORAL Rx AB - DEFERASIROXTEVA PHARMS USAANDA 21418020213 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 90MG GRANULE ORAL Discontinued — 180MG GRANULE ORAL Discontinued — 360MG GRANULE ORAL Discontinued — - DEFERASIROXAMNEALANDA 21419420213 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 180MG GRANULE ORAL Discontinued — 360MG GRANULE ORAL Discontinued — 90MG GRANULE ORAL Discontinued — - DEFERASIROXCHARTWELL RXANDA 21266920213 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 90MG TABLET ORAL Rx AB 180MG TABLET ORAL Rx AB 360MG TABLET ORAL Rx AB - DEFERASIROXANNORA PHARMAANDA 21434120213 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 90MG TABLET ORAL Rx AB 180MG TABLET ORAL Rx AB 360MG TABLET ORAL Rx AB - DEFERASIROXAUCTAANDA 21455920213 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 90MG GRANULE ORAL Rx AB 180MG GRANULE ORAL Rx AB 360MG GRANULE ORAL Rx AB - DEFERASIROXALKEM LABS LTDANDA 21337420203 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 90MG GRANULE ORAL Rx AB 180MG GRANULE ORAL Rx AB 360MG GRANULE ORAL Rx AB - DEFERASIROXZYDUS PHARMSANDA 20888220203 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 125MG TABLET, FOR SUSPENSION ORAL Discontinued — 250MG TABLET, FOR SUSPENSION ORAL Discontinued — 500MG TABLET, FOR SUSPENSION ORAL Discontinued — - DEFERASIROXALKEM LABS LTDANDA 21055520203 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 90MG TABLET ORAL Rx AB 360MG TABLET ORAL Rx AB 180MG TABLET ORAL Rx AB - DEFERASIROXCIPLAANDA 21185220203 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 90MG TABLET ORAL Discontinued — 360MG TABLET ORAL Discontinued — 180MG TABLET ORAL Discontinued — - DEFERASIROXGLENMARK SPECLTANDA 20943320203 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 125MG TABLET, FOR SUSPENSION ORAL Rx AB 250MG TABLET, FOR SUSPENSION ORAL Rx AB 500MG TABLET, FOR SUSPENSION ORAL Rx AB - DEFERASIROXSUN PHARMANDA 21164120203 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 90MG TABLET ORAL Discontinued — 360MG TABLET ORAL Discontinued — 180MG TABLET ORAL Discontinued — - DEFERASIROXPIRAMALANDA 21299520193 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 90MG TABLET ORAL Rx AB 360MG TABLET ORAL Rx AB 180MG TABLET ORAL Rx AB - DEFERASIROXSTEVENS JANDA 21072720193 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 90MG TABLET ORAL Discontinued — 360MG TABLET ORAL Discontinued — 180MG TABLET ORAL Discontinued — - DEFERASIROXACTAVIS ELIZABETHANDA 20869720193 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 90MG TABLET ORAL Rx AB 180MG TABLET ORAL Rx AB 360MG TABLET ORAL Rx AB - DEFERASIROXTEVA PHARMS USAANDA 20922320193 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 90MG TABLET ORAL Discontinued — 360MG TABLET ORAL Discontinued — 180MG TABLET ORAL Discontinued — - DEFERASIROXALEMBICANDA 21006020193 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 125MG TABLET, FOR SUSPENSION ORAL Rx AB 250MG TABLET, FOR SUSPENSION ORAL Rx AB 500MG TABLET, FOR SUSPENSION ORAL Rx AB - DEFERASIROXALKEM LABS LTDANDA 21051920193 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 125MG TABLET, FOR SUSPENSION ORAL Rx AB 250MG TABLET, FOR SUSPENSION ORAL Rx AB 500MG TABLET, FOR SUSPENSION ORAL Rx AB - DEFERASIROXBIONPHARMAANDA 21092020193 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 125MG TABLET, FOR SUSPENSION ORAL Rx AB 250MG TABLET, FOR SUSPENSION ORAL Rx AB 500MG TABLET, FOR SUSPENSION ORAL Rx AB - DEFERASIROXMSNANDA 20987820193 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 125MG TABLET, FOR SUSPENSION ORAL Rx AB 250MG TABLET, FOR SUSPENSION ORAL Rx AB 500MG TABLET, FOR SUSPENSION ORAL Rx AB - DEFERASIROXSUN PHARMANDA 20978220193 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 125MG TABLET, FOR SUSPENSION ORAL Rx AB 250MG TABLET, FOR SUSPENSION ORAL Rx AB 500MG TABLET, FOR SUSPENSION ORAL Rx AB - DEFERASIROXALEMBICANDA 21182420193 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 90MG TABLET ORAL Rx AB 360MG TABLET ORAL Rx AB 180MG TABLET ORAL Rx AB - DEFERASIROXMSNANDA 21094520193 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 90MG TABLET ORAL Rx AB 360MG TABLET ORAL Rx AB 180MG TABLET ORAL Rx AB - DEFERASIROXZYDUS PHARMSANDA 21138320193 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 90MG TABLET ORAL Rx AB 360MG TABLET ORAL Rx AB 180MG TABLET ORAL Rx AB - DEFERASIROXACTAVIS ELIZABETHANDA 20356020163 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 125MG TABLET, FOR SUSPENSION ORAL Rx AB 250MG TABLET, FOR SUSPENSION ORAL Rx AB 500MG TABLET, FOR SUSPENSION ORAL Rx AB
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 9283209 | in 8 yr 5 mo | SubstanceProduct |
Approval history
FDA approval span
First approval
21 yr 1 mo ago
Most recent approval
11 mo ago
Approvals span 2005–2025 across 38 FDA applications.
Brand (NDA) 38%
Generic (ANDA) 3592%
Deferasirox: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
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- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
