TheraRadar
Data updated: May 26, 2026

QDOLO (tramadol hydrochloride)

Trial Activity: Declining 2 active trials
Pain Approved 2020-09-01
Jump to: Indications Approvals Trials Competitors Safety Patents

Development Insights

Menarini Group conducting 2 trials (15%)
14 indications explored (Broad Platform)
→ pain (4 trials)
→ pain, acute (2 trials)
→ postoperative pain (2 trials)
1
Indication
--
Phase 3 Trials
5
Years on Market

Details

Status
Discontinued
First Approved
2020-09-01
Patent Cliff
2040

Pro Metrics

Patent cliff and revenue data

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Routes
ORAL
Dosage Forms
SOLUTION

Companies

ROSEMONT
Active Ingredient: TRAMADOL HYDROCHLORIDE

QDOLO Approval History

2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
5 FDA actions from 2020 to 2025
Dec 2025 SUPPL
Label · Labeling
FDA Letter Label
Oct 2024 SUPPL
Update · REMS
FDA Letter
Dec 2023 SUPPL
Label · Labeling
FDA Letter Label

What QDOLO Treats

1 FDA approvals

Originally approved for its first indication in 2020 .

  • Other (1)
📋

Clinical Trial Registry

12 trials
Trial Sponsor ID Phase Status Title
NCT07440069 TRAMPA PO-UNAH-49-7-2026 Ph 4 recruiting Analgesic Efficacy and Obstetric Effects of Tramadol, Paracetamol and Placebo in Active Labor
NCT04991493 QPOST Ph 4 recruiting Effect of Tramadol on Postoperative Sore Throat After General Anesthesia
NCT05125978 CANADÁ EMS1120 - CANADÁ Ph 2 withdrawn Efficacy and Safety of Canadá Association in the Treatment of Chronic Pain
NCT05390905 HSK21542-303 Ph 3 completed A Clinical Trial Evaluating the Efficacy and Safety of HSK21542 in Patients for Postoperative Pain Treatment
NCT04613830 515 Ph 3 completed Continuous Erector Spinae Block for Post Analgesia in Pediatric Patients
NCT03775629 CG100650-1-01 Ph 1 completed Drug-Drug Interaction Study of "CG100650" in Healthy Volunteers
NCT03477851 TramIsch WNOZA/1/2017 Ph 4 completed Tramadol Simultaneously With Sciatic Nerve Block for Calcaneus Fracture Osteosynthesis
NCT04178109 17200 Ph 2 completed Oral Use of Dexketoprofen/Tramadol for Acute Postoperative Pain in Total Hip Replacement With a Direct Anterior Approach.
NCT00737048 results posted CR015109 JNS013-JPN-03 Ph 3 completed A Comparative Study of JNS013 in Participants With Post-Tooth-Extraction Pain
NCT01307020 DEX-TRA 02 results posted DEX-TRA 02 2010-022798-32 Ph 2 completed Analgesic Effect of Different Combinations of Dexketoprofen Trometamol With Tramadol Hydrochloride in a Model of Moderate to Severe Pain
NCT00766675 results posted CR015319 TRAMMAPPAI4033 Ph 4 completed An Efficacy Study of Combination of Tramadol and Acetaminophen Tablets in the Treatment of Participants With Fibromyalgia Pain
NCT00983736 BVF-324-302 Ph 3 terminated Study to Evaluate Efficacy and Safety in Male Subjects With Premature Ejaculation
🔬

Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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📊

Trial Timeline

ClinicalTrials.gov ↗ Pro

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.

QDOLO FDA Label Details

View full patent landscape →
2 OB patents · 1 families · 5 international docs across 2 countries

QDOLO Patents & Exclusivity

Latest Patent: Sep 2040

Patents (2 active)

US11103452 Expires Sep 1, 2040
US11752103 Expires Sep 1, 2040
Source: FDA Orange Book

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Deep insights for QDOLO

Revenue Insights

  • • Quarterly revenue tracking
  • • Historical trend analysis

Patent Timeline

  • • Cliff: 2040
  • • 2 active patents

Trial Analysis

  • • 13 total trials
  • • Stage: Declining

Competitive Landscape

  • • Competitor tracking
  • • Same target/indication analysis
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Full approval history • All patents • Revenue trends • Competitor analysis

Data Sources

FDA Approval: NDA214044 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.

How We Calculate These Metrics

Trial Activity Stage

Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.

Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.

  • Growth: High proportion of early-phase trials (Phase 1/2), active development
  • Expansion: Significant Phase 3 activity, approaching or pursuing approvals
  • Mature: Substantial Phase 4 post-marketing studies
  • Stable: Mixed phase distribution, steady development
  • Declining: Low active trial ratio, reduced R&D investment