Data updated: Mar 10, 2026
BORTEZOMIB
BORTEZOMIB
Approved 2017-11-06
15
Indications
--
Phase 3 Trials
8
Years on Market
Details
- Status
- None (Tentative Approval)
- First Approved
- 2017-11-06
- Routes
- INJECTION, INTRAVENOUS, SUBCUTANEOUS, INTRAVENOUS
- Dosage Forms
- INJECTABLE, POWDER, SOLUTION
Companies
Teva Pfizer PHARMOBEDIENT JIANGSU HANSOH PHARM Dr. Reddy's ACCORD HLTHCARE Fresenius Kabi MSN RELIANCE LIFE SCI MAIA PHARMS INC PHARMASCIENCE INC HETERO LABS LTD VI SCINOPHARM TAIWAN Baxter CAPLIN ONE LABS ZYDUS PHARMS SHILPA EUGIA PHARMA GLAND Apotex MEITHEAL SHUANGCHENG VILIN BIO MED QILU PHARM HAINAN
Active Ingredient: BORTEZOMIB
Website: ↗
BORTEZOMIB Approval History
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What BORTEZOMIB Treats
15 FDA approvalsOriginally approved for its first indication in 2017 . Covers 15 distinct patient populations.
- Other (15)
Other
(15 approvals)- • Approved indication (Nov 2017)Label Letter
- • Approved indication (Oct 2019)Label Letter
- • Approved indication (Sep 2021)Label Letter
- • Approved indication (May 2022)Label Letter
- • Approved indication (Jul 2022)
- • Approved indication (Jul 2022)Label Letter
- • Approved indication (Oct 2022)
- • Approved indication (Oct 2022)
- • Approved indication (Dec 2022)Label Letter
- • Approved indication (Sep 2023)
- • Approved indication (May 2024)
- • Approved indication (Aug 2024)Label Letter
- • Approved indication (Jun 2025) New
- • Approved indication (Dec 2025) New
- • Approved indication (Jan 2026) NewLetter
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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.
BORTEZOMIB FDA Label Details
ProBORTEZOMIB Patents & Exclusivity
Latest Patent: Sep 2042
Patents (21 active)
US11752164
Expires Sep 23, 2042
US11679119
Expires Sep 23, 2042
US12005069
Expires Sep 23, 2042
US8962572
Expires Nov 3, 2032
+ 11 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.