Data updated: Mar 29, 2026
OFIRMEV
ACETAMINOPHEN
Approved 2010-11-02
2
Indications
--
Phase 3 Trials
2
Priority Reviews
15
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2010-11-02
- Routes
- INTRAVENOUS
- Dosage Forms
- SOLUTION
OFIRMEV Approval History
Loading approval history...
What OFIRMEV Treats
2 FDA approvalsOriginally approved for its first indication in 2010 . Covers 2 distinct patient populations.
- Other (2)
🔬
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.
OFIRMEV FDA Label Details
ProOFIRMEV Patents & Exclusivity
Latest Patent: Mar 2032
Patents (10 active)
US9399012*PED
Expires Mar 11, 2032
US9399012
Expires Sep 11, 2031
US9610265*PED
Expires May 13, 2029
US9987238*PED
Expires May 13, 2029
US10383834*PED
Expires May 13, 2029
US9987238
Expires Nov 13, 2028
US10383834
Expires Nov 13, 2028
US9610265
Expires Nov 13, 2028
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.