Data updated: Mar 10, 2026
OTREXUP
METHOTREXATE
Approved 2013-10-11
1
Indication
--
Phase 3 Trials
12
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2013-10-11
- Routes
- SUBCUTANEOUS
- Dosage Forms
- SOLUTION
OTREXUP Approval History
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What OTREXUP Treats
1 FDA approvalsOriginally approved for its first indication in 2013 .
- Other (1)
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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.
OTREXUP FDA Label Details
ProOTREXUP Patents & Exclusivity
Latest Patent: May 2031
Patents (960 active)
US8814834
Expires May 27, 2031
US8480631
Expires Mar 19, 2030
US8579865
Expires Mar 19, 2030
US8945063
Expires Mar 19, 2030
US9421333
Expires Mar 19, 2030
US11497753
Expires Mar 19, 2030
US12357642
Expires Mar 19, 2030
US10709844
Expires Mar 10, 2029
US11684723
Expires Mar 10, 2029
US9867949
Expires Mar 10, 2029
+ 950 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.