Data updated: May 26, 2026
VIVLODEX (meloxicam)
Pain
Approved 2015-10-22
1
Indication
--
Phase 3 Trials
10
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2015-10-22
- Patent Cliff
- 2035
- Routes
- ORAL
- Dosage Forms
- CAPSULE
VIVLODEX Approval History
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
8 FDA actions from 2015 to 2024
May 2016 SUPPL
Mfg · Manufacturing (CMC)
What VIVLODEX Treats
1 FDA approvalsOriginally approved for its first indication in 2015 .
- Other (1)
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Clinical Trial Registry
12 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04115098 results posted | HSC-MS-19-0677 KL2TR003168 | Ph 2 | terminated | Individualizing Anti-Inflammatory Medications for Adults With Axial Spondyloarthritis: A Series of N-of 1 Trials |
| NCT01147289 Dextra | EF 102 | Ph 3 | completed | Efficacy and Safety of Injectable Association of Dexamethasone, Dipyrone and Hydrocobalamin in Lumbar Sciatic Pain |
| NCT05974501 results posted | 20230147 | Ph 4 | completed | Pre vs Post Block in Total Knee Arthroplasty (TKA) |
| NCT03896009 MOMENTUM results posted | AXS-07-301 | Ph 3 | completed | Maximizing Outcomes in Treating Acute Migraine |
| NCT04766996 results posted | STUDY00002021 | Ph 4 | terminated | PROUD Study - Preventing Opioid Use Disorders |
| NCT02706054 | MELO-RCT | Ph 3 | completed | Treatment of Recent Onset Low Back Pain With Periradicular Injections of Meloxicam |
| NCT03586934 | ORA 17071004 | Ph 3 | withdrawn | Multimodal Analgesia in Shoulder Arthroplasty |
| NCT02078102 results posted | IUCRO-0419 CA182947, 1312925163 | Ph 2 | completed | A Phase II Trial Using Meloxicam Plus Filgrastim in Patients With Multiple Myeloma and Non-Hodgkin's Lymphoma |
| NCT03473665 results posted | AAAR3505 | Ph 4 | terminated | Non-Steroidal Anti-inflammatory Drugs in Axial Spondyloarthritis |
| NCT02003625 results posted | 13-195 | Ph 2 | completed | Meloxicam vs Placebo for Mobilization |
| NCT02255045 | AVM002 | Ph 2, Ph 3 | completed | Assessment of a Vaginal Ring With Meloxicam in the Treatment of Dysmenorrhea |
| NCT02298218 | 4-2008-0597 | Ph 4 | completed | Clinical Study About the Role of COX-2 Inhibitor in Liver Cirrhosis With Biliary Atresia |
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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.
VIVLODEX FDA Label Details
View full patent landscape →
3 OB patents · 1 families ·
30 international docs across 18 countries
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Deep insights for VIVLODEX
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2035
- • 16 active patents
Trial Analysis
- • Clinical trial tracking
- • Development stage analysis
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- • 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.