FDA Orange Book · active-ingredient family
Docetaxel
Docetaxel is approved as 11 brand and 20 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:BEIZRAY · NDA 218711
11
Brand (NDA)
20
Generics (ANDA)
8
Listed patents
0
Exclusivity periods
Brand (NDA) products · injectable, solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| BEIZRAYRLD | ZHUHAI | NDA 218711 | — | Oct 23, 2024 | |
| DOCIVYXRLD×3 | AVYXA HOLDINGS | NDA 215813 | — | Nov 22, 2022 | |
| DOCETAXELRLD×3 | SHILPA | NDA 205934 | AP | Dec 22, 2015 | |
| DOCETAXELRLD×5 | ACCORD HLTHCARE | NDA 201195 | — | Jun 08, 2011 | |
| DOCEFREZRLD×5 | SUN PHARM | NDA 022534 | — | May 03, 2011 | |
| DOCETAXELRLD×7 | HOSPIRA INC | NDA 022234 | AP | Mar 08, 2011 | |
| TAXOTERERLD×4 | SANOFI AVENTIS US | NDA 020449 | — | Aug 03, 2010 | |
| DOCETAXEL×4 | PFIZER LABS | NDA 202356 | — | Mar 13, 2014 | |
| DOCETAXEL×4 | ACTAVIS | NDA 203551 | AP | Apr 12, 2013 | |
| DOCETAXEL×2 | APOTEX INC | NDA 022312 | — | Jan 11, 2012 | |
| DOCETAXEL×3 | SANDOZ | NDA 201525 | AP | Jun 29, 2011 |
Generic (ANDA) products (20)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| DOCETAXEL×2 | GUANGDONG SUNHO | ANDA 213768 | AP | May 13, 2025 | |
| DOCETAXEL×3 | HERITAGE | ANDA 216677 | AP | Feb 28, 2024 | |
| DOCETAXEL×2 | PHARMOBEDIENT | ANDA 203892 | — | May 11, 2023 | |
| DOCETAXEL×3 | ALEMBIC | ANDA 215744 | AP | Feb 28, 2023 | |
| DOCETAXEL×3 | GLAND | ANDA 213510 | AP | Jul 01, 2021 | |
| DOCETAXEL×3 | EUGIA PHARMA | ANDA 214575 | — | Jun 25, 2021 | |
| DOCETAXEL×2 | HIKMA | ANDA 204490 | AP | Jan 14, 2021 | |
| DOCETAXEL×3 | SHILPA | ANDA 210327 | AP | May 16, 2019 | |
| DOCETAXEL | MYLAN LABS LTD | ANDA 208137 | AP | Apr 01, 2019 | |
| DOCETAXEL×3 | MEITHEAL | ANDA 209634 | AP | Aug 24, 2018 | |
| DOCETAXEL | MYLAN LABS LTD | ANDA 210848 | AP | Jul 06, 2018 | |
| DOCETAXEL | MYLAN LABS LTD | ANDA 210072 | AP | Jul 02, 2018 | |
| DOCETAXEL | MYLAN LABS LTD | ANDA 208859 | AP | Apr 30, 2018 | |
| DOCETAXEL×3 | AMNEAL | ANDA 209640 | AP | Jan 19, 2018 | |
| DOCETAXEL×3 | INGENUS PHARMS LLC | ANDA 207563 | — | Aug 31, 2017 | |
| DOCETAXEL×3 | HENGRUI PHARMA | ANDA 207252 | AP | Aug 09, 2017 | |
| DOCETAXEL | HENGRUI PHARMA | ANDA 203170 | — | Feb 15, 2017 | |
| DOCETAXEL×3 | DFB ONCOLOGY LTD | ANDA 206177 | — | Jan 20, 2017 | |
| DOCETAXEL×2 | TEVA PHARMS USA | ANDA 203877 | — | Sep 16, 2015 | |
| DOCETAXEL×2 | DR REDDYS | ANDA 204193 | AP | Nov 05, 2014 |
Listed patents (8)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10842770 | Aug 07, 2031 | in 5 yr 3 mo | ProductU-2998 |
| 9763880 | Sep 30, 2033 | in 7 yr 5 mo | U-2560 |
| 8940786 | Sep 30, 2033 | in 7 yr 5 mo | ProductU-1789 |
| 9308195 | Sep 30, 2033 | in 7 yr 5 mo | Product |
| 10398785 | Mar 14, 2036 | in 9 yr 11 mo | Product |
| 11419842 | May 16, 2036 | in 10 yr 1 mo | ProductU-881 |
| 12090134 | May 16, 2036 | in 10 yr 1 mo | ProductU-881 |
| 12090135 | May 16, 2036 | in 10 yr 1 mo | Product |
Docetaxel — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
