TheraRadar
Data updated: Jun 28, 2026

ATMEKSI (methocarbamol) · ROSEMONT PHARMS

Musculoskeletal Approved 2025-07-30

ATMEKSI (methocarbamol) oral suspension is a muscle relaxant indicated as: an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions in patients 16 and older. 1.1 Acute, painful musculoskeletal conditions.

1
Indication
--
Phase 3 Trials
0
Years on Market

Details

Status
Prescription
First Approved
2025-07-30
Patent Cliff
2044

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Routes
ORAL
Dosage Forms
SUSPENSION

Companies

Active Ingredient: METHOCARBAMOL

ATMEKSI Approval History

2026
Original
New Indication
New Form
Label Update
2 FDA actions from 2025 to 2025
Jul 2025 ORIGINAL
Update

What ATMEKSI Treats

1 indications

ATMEKSI is approved for 1 conditions since its original approval in 2025. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Musculoskeletal Conditions
Source: FDA Label

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ROBAXIN
METHOCARBAMOL
1 shared
ENDO OPERATIONS
Shared indications:
Musculoskeletal Conditions
📋

Clinical Trial Registry

6 trials
Trial Sponsor ID Phase Status Title
NCT05603832 100-CIP02-P Ph 3 completed A Phase 3 Study of F14 for Management of Pain Following Total Knee Replacement
NCT05388929 1913843 Ph 4 active not recruiting Methocarbamol in Ventral and Inguinal HR
NCT05076110 results posted 21-003441 Ph 4 completed Nonopioid Pain Control Regimen After Arthroscopic Hip Procedures
NCT02432456 results posted PRO00024679 Ph 4 completed Ketamine Infusion Therapy for the Management of Acute Pain in Adult Rib Fracture Patients
NCT02831569 results posted 1387.1 Ph 3 completed Japanese IP-TN Trial
NCT02665286 results posted 2015-5903 Ph 4 completed Orphenadrine and Methocarbamol for LBP
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Active Pipeline

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Key Completed Trials

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Trial Timeline

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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.

ATMEKSI FDA Label Details

Indications & Usage

FDA Label (PDF)

ATMEKSI (methocarbamol) oral suspension is a muscle relaxant indicated as: an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions in patients 16 and older. 1.1 Acute, painful musculoskeletal conditions. ATMEKSI is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions in patients 16 and older.

View full patent landscape →
1 OB patents · 1 families · 3 international docs across 1 countries

ATMEKSI Patents & Exclusivity

Latest Patent: Oct 2044

Patents (1 active)

US12390439 Expires Oct 9, 2044
Source: FDA Orange Book

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Patent Timeline

  • Cliff: 2044
  • 2 active patents

Trial Analysis

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  • Development stage analysis

Competitive Landscape

  • 1 similar drugs
  • Same target/indication analysis
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Data Sources

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