FDA Orange Book
Generic for Jevtana Kit
Jevtana Kit contains cabazitaxel. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
Yes. The generic name for Jevtana Kit is cabazitaxel. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
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Jevtana Kit products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| solution, intravenous | 60MG/1.5ML (40MG/ML) | Marketed (Rx) | AP | 2 | AP |
NDA 201023, held by SANOFI AVENTIS US INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic cabazitaxel
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| ACCORD HEALTHCARE INC | 207693 | AP (A-rated, therapeutically equivalent) | October 26, 2022 | 60MG/1.5ML (40MG/ML) |
| DR REDDYS LABORATORIES LTD | 207718 | AP (A-rated, therapeutically equivalent) | February 10, 2023 | 60MG/1.5ML (40MG/ML) |
Jevtana Kit patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 7241907 | December 10, 2025 | Drug substance | None | 201023 |
| 7241907*PED | June 10, 2026 | Method of use | None | 201023 |
| 12453712 | October 27, 2030 | Method of use | U-4334 | 201023 |
| 10583110 | October 27, 2030 | Method of use | U-2753 | 201023 |
| 10716777 | October 27, 2030 | Method of use | U-2856 | 201023 |
| 8927592 | October 27, 2030 | Method of use | U-3200 | 201023 |
| 8927592*PED | April 27, 2031 | Method of use | None | 201023 |
| 10583110*PED | April 27, 2031 | Method of use | None | 201023 |
| 10716777*PED | April 27, 2031 | Method of use | None | 201023 |
| 12453712*PED | April 27, 2031 | Method of use | None | 201023 |
Questions
Is there a generic for Jevtana Kit?
Yes. The generic name for Jevtana Kit is cabazitaxel. 2 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
What is the generic name for Jevtana Kit?
The active ingredient in Jevtana Kit is cabazitaxel, per the FDA Orange Book.
When does the Jevtana Kit patent expire?
The last patent listed for Jevtana Kit in the Orange Book expires April 27, 2031. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.