FDA Orange Book
Generic for Taxol
Taxol contains paclitaxel. 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 Taxol is paclitaxel. 9 companies hold an active FDA approval (ANDA) for a generic version in the Orange Book. Therapeutic equivalence codes: AP.
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Taxol products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| injectable, injection | 6MG/ML | Discontinued | None | 9 | AP |
NDA 020262, held by HQ SPECIALTY PHARMA CORP. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Approved generic paclitaxel
| Company | ANDA | TE code | Approved | Strengths |
|---|---|---|---|---|
| TEVA PHARMACEUTICALS USA | 075184 | AP (A-rated, therapeutically equivalent) | January 25, 2002 | 6MG/ML |
| HIKMA PHARMACEUTICALS USA INC | 075190 | AP (A-rated, therapeutically equivalent) | January 28, 2002 | 6MG/ML |
| HOSPIRA INC | 076131 | AP (A-rated, therapeutically equivalent) | May 8, 2002 | 6MG/ML |
| FRESENIUS KABI USA LLC | 077574 | AP (A-rated, therapeutically equivalent) | November 27, 2006 | 6MG/ML |
| ACTAVIS TOTOWA LLC | 090130 | AP (A-rated, therapeutically equivalent) | December 9, 2009 | 6MG/ML |
| GLAND PHARMA LTD | 207326 | AP (A-rated, therapeutically equivalent) | August 23, 2016 | 6MG/ML |
| ACCORD HEALTHCARE INC | 205720 | AP (A-rated, therapeutically equivalent) | August 17, 2018 | 6MG/ML |
| MSN LABORATORIES PRIVATE LTD | 213434 | AP (A-rated, therapeutically equivalent) | August 24, 2020 | 6MG/ML |
| ALEMBIC PHARMACEUTICALS LTD | 216874 | AP (A-rated, therapeutically equivalent) | October 20, 2022 | 6MG/ML |
Questions
Is there a generic for Taxol?
Yes. The generic name for Taxol is paclitaxel. 9 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 Taxol?
The active ingredient in Taxol is paclitaxel, 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.