FDA Orange Book · active-ingredient family
Cabazitaxel
Cabazitaxel: 3 brands, 5 generics; first approved Jun 17, 2010; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 5 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
3
Generics (ANDA)
5
Listed patents
10
Next patent expiry
Dec 10, 2025
8 mo ago
Brand (NDA) products
Originator applications
- CABAZITAXELRLDACTAVISNDA 2079702024
Approved strengths under this FDA application. Strength Dosage form Route Status TE 60MG/6ML (10MG/ML) SOLUTION INTRAVENOUS Discontinued — - CABAZITAXELRLDACCORD HLTHCARENDA 2079492021
Approved strengths under this FDA application. Strength Dosage form Route Status TE 60MG/3ML (20MG/ML) SOLUTION INTRAVENOUS Discontinued — - SANOFI AVENTIS USNDA 2010232010
Approved strengths under this FDA application. Strength Dosage form Route Status TE 60MG/1.5ML (40MG/ML) SOLUTION INTRAVENOUS Rx AP
Generic (ANDA) products (5)
Abbreviated applications
- CABAZITAXELMYLAN LABS LTDANDA 2073812023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 60MG/1.5ML (40MG/ML) SOLUTION INTRAVENOUS Discontinued — - CABAZITAXELAPOTEXANDA 2077362023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 60MG/1.5ML (40MG/ML) SOLUTION INTRAVENOUS Discontinued — - CABAZITAXELDR REDDYSANDA 2077182023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 60MG/1.5ML (40MG/ML) SOLUTION INTRAVENOUS Rx AP - CABAZITAXELACCORD HLTHCAREANDA 2076932022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 60MG/1.5ML (40MG/ML) SOLUTION INTRAVENOUS Rx AP - CABAZITAXELBRECKENRIDGEANDA 2076192022
Approved strengths under this FDA application. Strength Dosage form Route Status TE 60MG/1.5ML (40MG/ML) SOLUTION INTRAVENOUS Discontinued —
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 7241907 | 8 mo ago | Substance | |
| 7241907*PED | 2 mo ago | ||
| 12453712 | in 4 yr 3 mo | U-4334 | |
| 10583110 | in 4 yr 3 mo | U-2753 | |
| 10716777 | in 4 yr 3 mo | U-2856 | |
| 8927592 | in 4 yr 3 mo | U-3200 | |
| 8927592*PED | in 4 yr 9 mo | ||
| 10583110*PED | in 4 yr 9 mo | ||
| 10716777*PED | in 4 yr 9 mo | ||
| 12453712*PED | in 4 yr 9 mo |
Approval history
FDA approval span
First approval
16 yr 5 mo ago
Most recent approval
2 yr 6 mo ago
Approvals span 2010–2024 across 8 FDA applications.
Brand (NDA) 338%
Generic (ANDA) 563%
Cabazitaxel: 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
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 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.
