Data updated: Mar 10, 2026
QTERNMET XR
DAPAGLIFLOZIN
Approved 2019-05-02
1
Indication
--
Phase 3 Trials
6
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2019-05-02
- Routes
- ORAL
- Dosage Forms
- TABLET, EXTENDED RELEASE
Companies
Website: ↗
QTERNMET XR Approval History
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What QTERNMET XR Treats
1 FDA approvalsOriginally approved for its first indication in 2019 .
- Other (1)
🔬
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.
QTERNMET XR FDA Label Details
ProQTERNMET XR Patents & Exclusivity
Latest Patent: May 2031
Patents (160 active)
US9616028*PED
Expires May 12, 2031
US9616028
Expires Nov 12, 2030
US7919598*PED
Expires Jun 16, 2030
US7919598
Expires Dec 16, 2029
US8716251*PED
Expires Sep 21, 2028
US8716251
Expires Mar 21, 2028
US8501698*PED
Expires Dec 20, 2027
US8501698
Expires Jun 20, 2027
US6515117*PED
Expires Apr 4, 2026
US6515117
Expires Oct 4, 2025
+ 150 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.