FDA Orange Book · active-ingredient family
Cabazitaxel
Cabazitaxel is approved as 3 brand and 5 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:CABAZITAXEL · NDA 207970
3
Brand (NDA)
5
Generics (ANDA)
10
Listed patents
0
Exclusivity periods
Brand (NDA) products · solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CABAZITAXELRLD | ACTAVIS | NDA 207970 | — | Mar 14, 2024 | |
| CABAZITAXELRLD | ACCORD HLTHCARE | NDA 207949 | — | Dec 29, 2021 | |
| JEVTANA KITRLD | SANOFI AVENTIS US | NDA 201023 | AP | Jun 17, 2010 |
Generic (ANDA) products (5)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| CABAZITAXEL | MYLAN LABS LTD | ANDA 207381 | — | Jul 05, 2023 | |
| CABAZITAXEL | APOTEX | ANDA 207736 | — | Feb 10, 2023 | |
| CABAZITAXEL | DR REDDYS | ANDA 207718 | AP | Feb 10, 2023 | |
| CABAZITAXEL | ACCORD HLTHCARE | ANDA 207693 | AP | Oct 26, 2022 | |
| CABAZITAXEL | BRECKENRIDGE | ANDA 207619 | — | Jun 23, 2022 |
Listed patents (10)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7241907 | Dec 10, 2025 | 6 mo ago | Substance |
| 7241907*PED | Jun 10, 2026 | 9 d ago | |
| 12453712 | Oct 27, 2030 | in 4 yr 5 mo | U-4334 |
| 10583110 | Oct 27, 2030 | in 4 yr 5 mo | U-2753 |
| 10716777 | Oct 27, 2030 | in 4 yr 5 mo | U-2856 |
| 8927592 | Oct 27, 2030 | in 4 yr 5 mo | U-3200 |
| 8927592*PED | Apr 27, 2031 | in 4 yr 11 mo | |
| 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 |
Cabazitaxel — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
