Data updated: Mar 10, 2026
DOCETAXEL
DOCETAXEL
Approved 2011-03-08
31
Indications
--
Phase 3 Trials
15
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2011-03-08
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
Companies
PHARMOBEDIENT HENGRUI PHARMA Viatris HERITAGE ALEMBIC Teva GLAND DFB ONCOLOGY LTD ACCORD HLTHCARE SHILPA INGENUS PHARMS LLC AMNEAL Pfizer GUANGDONG SUNHO Sun Pharma Novartis Dr. Reddy's Hikma EUGIA PHARMA AVYXA HOLDINGS MEITHEAL Apotex
Active Ingredient: DOCETAXEL
Website: ↗
DOCETAXEL Approval History
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What DOCETAXEL Treats
31 FDA approvalsOriginally approved for its first indication in 2011 . Covers 31 distinct patient populations.
- Other (31)
Other
(31 approvals)- • Approved indication (Mar 2011)Label Letter
- • Approved indication (May 2011)Label Letter
- • Approved indication (Jun 2011)Label Letter
- • Approved indication (Jun 2011)Label Letter
- • Approved indication (Jan 2012)Label Letter
- • Approved indication (Apr 2013)Label Letter
- • Approved indication (Mar 2014)Label Letter
- • Approved indication (Jul 2014)Label Letter
- • Approved indication (Nov 2014)
- • Approved indication (Sep 2015)
- • Approved indication (Dec 2015)Label Letter
- • Approved indication (Jan 2017)
- • Approved indication (Feb 2017)
- • Approved indication (Aug 2017)Letter
- • Approved indication (Aug 2017)Letter
- • Approved indication (Jan 2018)
- • Approved indication (Apr 2018)
- • Approved indication (Jul 2018)
- • Approved indication (Jul 2018)
- • Approved indication (Aug 2018)
- • Approved indication (Jan 2019)Label Letter
- • Approved indication (Apr 2019)
- • Approved indication (May 2019)
- • Approved indication (Jan 2021)
- • Approved indication (Jun 2021)
- • Approved indication (Jul 2021)
- • Approved indication (Nov 2022)Label Letter
- • Approved indication (Feb 2023)
- • Approved indication (May 2023)
- • Approved indication (Feb 2024)
- • Approved indication (May 2025) New
🔬
Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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📊
Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
DOCETAXEL FDA Label Details
ProDOCETAXEL Patents & Exclusivity
Latest Patent: Mar 2036
Patents (93 active)
US10398785
Expires Mar 14, 2036
US9763880
Expires Sep 30, 2033
US8940786
Expires Sep 30, 2033
US9308195
Expires Sep 30, 2033
US10842770
Expires Aug 7, 2031
+ 83 more patents
Source: FDA Orange Book
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.