NDAORALTABLETPriority Review
Approved
Aug 1977
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
2
Data completeness
4/8 — Partial
Priority Review
FLEXERIL (cyclobenzaprine hydrochloride) by Johnson & Johnson is cyclobenzaprine hydrochloride relieves skeletal muscle spasm of local origin without interfering with muscle function. First approved in 1977.
Drug data last refreshed 1h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Flexeril (cyclobenzaprine hydrochloride) is an oral skeletal muscle relaxant approved in 1977 that relieves muscle spasm of local origin by reducing tonic somatic motor activity at the brainstem level. It works centrally without interfering with muscle function and is ineffective for spasms caused by CNS disease. The drug exhibits tricyclic antidepressant-like properties including anticholinergic effects and sedation.
LOE Approaching
Product is in LOE-approaching stage with moderate competitive pressure (30/100), suggesting transition planning and defensive strategies are active priorities for commercial teams.
Mechanism of Action
Cyclobenzaprine hydrochloride relieves skeletal muscle spasm of local origin without interfering with muscle function. It is ineffective in muscle spasm due to central nervous system disease. Cyclobenzaprine reduced or abolished skeletal muscle hyperactivity in several animal models. Animal studies…
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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.