Orange Book product · Brand (NDA)
JEVTANA KIT
CABAZITAXEL
At a glance
Jun 17, 2010
Approved
Brand (NDA)
Application
AP
TE code
10
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jun 17, 2010
16 yr 3 mo ago
Patent 7241907 expires
Listed drug substance patent expiration.
Dec 10, 2025
6 mo ago
Patent 7241907*PED expires
Listed listed patent expiration.
Jun 10, 2026
9 d ago
Today
Patent 10583110 expires
Listed method-of-use patent (U-2753) expiration.
Oct 27, 2030
in 4 yr 5 mo
Patent 10716777 expires
Listed method-of-use patent (U-2856) expiration.
Oct 27, 2030
in 4 yr 5 mo
Patent 12453712 expires
Listed method-of-use patent (U-4334) expiration.
Oct 27, 2030
in 4 yr 5 mo
Patent 8927592 expires
Listed method-of-use patent (U-3200) expiration.
Oct 27, 2030
in 4 yr 5 mo
Patent 10583110*PED expires
Listed listed patent expiration.
Apr 27, 2031
in 4 yr 11 mo
Patent 10716777*PED expires
Listed listed patent expiration.
Apr 27, 2031
in 4 yr 11 mo
Patent 12453712*PED expires
Listed listed patent expiration.
Apr 27, 2031
in 4 yr 11 mo
Patent 8927592*PED expires
Listed listed patent expiration.
Apr 27, 2031
in 4 yr 11 mo
Pharmaceutical detail
Active ingredient
CABAZITAXEL
Strength
60MG/1.5ML (40MG/ML)
Dosage form
SOLUTION
Route
INTRAVENOUS
TE code
AP
Application
NDA 201023
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
- 2024CABAZITAXELBrand (NDA)
NDA 207970 · ACTAVIS
- 2021CABAZITAXELBrand (NDA)
NDA 207949 · ACCORD HLTHCARE
- 2023CABAZITAXELGeneric (ANDA)
ANDA 207381 · MYLAN LABS LTD
- 2023CABAZITAXELGeneric (ANDA)
ANDA 207736 · APOTEX
- 2023CABAZITAXELGeneric (ANDA)
ANDA 207718 · DR REDDYS
- 2022CABAZITAXELGeneric (ANDA)
ANDA 207693 · ACCORD HLTHCARE
- 2022CABAZITAXELGeneric (ANDA)
ANDA 207619 · BRECKENRIDGE
Listed patents (10)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7241907 | Dec 10, 2025 | 6 mo ago | Substance |
| 7241907*PED | Jun 10, 2026 | 9 d ago | |
| 10583110 | Oct 27, 2030 | in 4 yr 5 mo | U-2753 |
| 10716777 | Oct 27, 2030 | in 4 yr 5 mo | U-2856 |
| 12453712 | Oct 27, 2030 | in 4 yr 5 mo | U-4334 |
| 8927592 | Oct 27, 2030 | in 4 yr 5 mo | U-3200 |
| 10583110*PED | Apr 27, 2031 | in 4 yr 11 mo | |
| 10716777*PED | Apr 27, 2031 | in 4 yr 11 mo | |
| 12453712*PED | Apr 27, 2031 | in 4 yr 11 mo | |
| 8927592*PED | Apr 27, 2031 | in 4 yr 11 mo |
