FDA Orange Book
Generic for Taxotere
Taxotere contains docetaxel. 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 Taxotere is docetaxel. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP. Generics match 3 of the 4 Taxotere products the Orange Book lists.
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Taxotere products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | 160MG/8ML (20MG/ML) | Marketed (Rx) | AP | 5 | AP |
| injectable, injection | 20MG/ML (20MG/ML) | Discontinued | None | 6 | AP |
| injectable, injection | 40MG/ML | Discontinued | None | 0 | None |
| injectable, injection | 80MG/4ML (20MG/ML) | Discontinued | None | 6 | AP |
NDA 020449, held by SANOFI AVENTIS US LLC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic docetaxel
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| DR REDDYS LABORATORIES LTD | 204193 | AP (A-rated, therapeutically equivalent) | November 5, 2014 | 20MG/ML (20MG/ML), 80MG/4ML (20MG/ML) |
| JIANGSU HENGRUI PHARMACEUTICALS CO LTD | 207252 | AP (A-rated, therapeutically equivalent) | August 9, 2017 | 160MG/8ML (20MG/ML), 20MG/ML (20MG/ML), 80MG/4ML (20MG/ML) |
| AMNEAL EU LTD | 209640 | AP (A-rated, therapeutically equivalent) | January 19, 2018 | 160MG/8ML (20MG/ML), 20MG/ML (20MG/ML), 80MG/4ML (20MG/ML) |
| MYLAN LABORATORIES LTD | 208137 | AP (A-rated, therapeutically equivalent) | April 1, 2019 | 160MG/8ML (20MG/ML) |
| ADAPTIS PHARMA PRIVATE LTD | 210327 | AP (A-rated, therapeutically equivalent) | May 16, 2019 | 160MG/8ML (20MG/ML), 20MG/ML (20MG/ML), 80MG/4ML (20MG/ML) |
| HIKMA FARMACEUTICA PORTUGAL SA | 204490 | AP (A-rated, therapeutically equivalent) | January 14, 2021 | 20MG/ML (20MG/ML), 80MG/4ML (20MG/ML) |
| HERITAGE PHARMACEUTICALS INC DBA AVET PHARMACEUTICALS INC | 216677 | AP (A-rated, therapeutically equivalent) | November 26, 2024 | 160MG/8ML (20MG/ML), 20MG/ML (20MG/ML), 80MG/4ML (20MG/ML) |
Taxotere NDC codes
Questions
Is there a generic for Taxotere?
Yes. The generic name for Taxotere is docetaxel. 7 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP. Generics match 3 of the 4 Taxotere products the Orange Book lists.
What is the generic name for Taxotere?
The active ingredient in Taxotere is docetaxel, per the FDA Orange Book.
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.