Data updated: Nov 8, 2026
Andexxa (coagulation factor xa (recombinant), inactivated-zhzo) · AstraZeneca
Approved 2018-05-03
1
Indication
--
Phase 3 Trials
8
Years on Market
Details
- Status
- Disc
- First Approved
- 2018-05-03
- Patent Cliff
- 2025
- Revenue
- $59M (Q4-2024)
- Routes
- Intravenous
- Dosage Forms
- Injection
Companies
Active Ingredient: Coagulation Factor Xa (Recombinant), Inactivated-zhzo , Coagulation Factor Xa (Recombinant), Inactivated-zhzo
Website: ↗
Andexxa Approval History
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
1 FDA actions from 2018 to 2018
May 2018 ORIGINAL
Update · CBER biologic (Purple Book)
What Andexxa Treats
1 FDA approvalsOriginally approved for its first indication in 2018 .
- Other (1)
Other
(1 approval)- • Approved indication (May 2018)
AstraZeneca's other novel FDA approvals
Other CDER-designated drugs from the same sponsor (2016–2025).
TRUQAP
2023 CAPIVASERTIB
3 designations
BEYFORTUS
2023 NIRSEVIMAB-ALIP
1 designation
WAINUA (AUTOINJECTOR)
2023 EPLONTERSEN SODIUM
1 designation
IMJUDO
2022 TREMELIMUMAB-ACTL
1 designation
SAPHNELO
2021 ANIFROLUMAB-FNIA
2 designations
TEZSPIRE
2021 TEZEPELUMAB-EKKO
2 designations
KOSELUGO
2020 SELUMETINIB
4 designations
LOKELMA
2018 SODIUM ZIRCONIUM CYCLOSILICATE
CALQUENCE
2017 ACALABRUTINIB MALEATE
4 designations
FASENRA
2017 BENRALIZUMAB
IMFINZI
2017 DURVALUMAB
3 designations
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Pro Key Completed Trials
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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.
Andexxa FDA Label Details
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Revenue Insights
- • Q4-2024: $59M
- • Historical trend analysis
Patent Timeline
- • Cliff: 2025
- • Generic/biosimilar risk
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
Competitive Landscape
- • Competitor tracking
- • Same target/indication analysis
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.