Data updated: Mar 10, 2026
XARTEMIS XR
ACETAMINOPHEN
Approved 2014-03-11
1
Indication
--
Phase 3 Trials
1
Priority Reviews
12
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2014-03-11
- Routes
- ORAL
- Dosage Forms
- TABLET, EXTENDED RELEASE
XARTEMIS XR Approval History
Loading approval history...
What XARTEMIS XR Treats
1 FDA approvalsOriginally approved for its first indication in 2014 .
- Other (1)
🔬
Pro Active Pipeline
Ongoing clinical trials by development phase
Loading...
⭐
Pro Key Completed Trials
Completed studies with published results, ranked by significance
Loading...
📊
Trial Timeline
Full development history with FDA approval milestones
Loading...
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.
XARTEMIS XR FDA Label Details
ProXARTEMIS XR Patents & Exclusivity
Latest Patent: May 2032
Patents (12 active)
US8741885
Expires May 16, 2032
US9468636
Expires May 16, 2032
US9050335
Expires May 16, 2032
US8992975
Expires May 16, 2032
US8658631
Expires May 16, 2032
US8597681
Expires Dec 21, 2030
US8980319
Expires Dec 21, 2030
US8377453
Expires Nov 19, 2029
US8668929
Expires Mar 11, 2029
US8372432
Expires Mar 11, 2029
+ 2 more patents
Source: FDA Orange Book
Want competitive intelligence?
See who's developing similar drugs and track their progress
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.