NDAORALTABLET
Approved
Jul 1957
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
2/8 — Basic
ROBAXIN (methocarbamol) by Hikma is clinical pharmacology the mechanism of action of methocarbamol in humans has not been established, but may be due to general central nervous system (cns) depression. First approved in 1957.
Drug data last refreshed 12h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Robaxin (methocarbamol) is an oral muscle relaxant approved in 1957 that works through general CNS depression, though its exact mechanism in humans is not fully established. It is indicated for acute musculoskeletal pain and muscle spasm, with no direct action on muscle contractile mechanisms. The drug is a small-molecule CNS depressant with a short half-life of 1-2 hours.
LOE Approaching
Product faces imminent loss of exclusivity with moderate competitive pressure (30/100), indicating a transition from brand-focused to generic/biosimilar competition requiring cost containment and defensive strategies.
Mechanism of Action
CLINICAL PHARMACOLOGY The mechanism of action of methocarbamol in humans has not been established, but may be due to general central nervous system (CNS) depression. It has no direct action on the contractile mechanism of striated muscle, the motor end plate or the nerve fiber. Pharmacokinetics In…
Indications
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.