NDAORALTABLETPriority Review
Approved
Aug 1977
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
2
Data completeness
3/8 — Basic
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 14h ago · AI intelligence enriched 5d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
FLEXERIL (cyclobenzaprine HCl) is an oral small-molecule muscle relaxant that relieves skeletal muscle spasm of local origin by reducing tonic somatic motor activity at the brainstem level, without directly affecting the neuromuscular junction. It is ineffective for muscle spasm caused by central nervous system disease and is used as adjunctive therapy for acute musculoskeletal conditions. The drug exhibits tricyclic antidepressant-like pharmacology, including anticholinergic and sedating properties.
LOE Approaching
Product is approaching loss of exclusivity with moderate competitive pressure (30%), signaling contraction phase for brand teams and shift toward generic/established product support roles.
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.