NDAINJECTIONINJECTABLEPriority Review
Approved
Nov 1983
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
2/8 — Basic
Priority Review
TRACRIUM (atracurium besylate) by Pfizer is clinical pharmacology atracurium besylate is a nondepolarizing skeletal muscle relaxant. First approved in 1983.
Drug data last refreshed 9h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
TRACRIUM (atracurium besylate) is a nondepolarizing skeletal muscle relaxant administered intravenously during anesthesia to facilitate intubation and surgical paralysis. It works by competitively antagonizing acetylcholine at the motor end-plate, with a duration of approximately one-third to one-half that of longer-acting agents like pancuronium. The drug is metabolized via organ-independent Hofmann elimination and ester hydrolysis, making it suitable for patients with hepatic or renal impairment.
LOE Approaching
As a legacy anesthetic agent nearing loss of exclusivity with moderate competitive pressure (30), the brand team is likely focused on defending market share rather than expansion; smaller, specialized commercial infrastructure remains.
Mechanism of Action
CLINICAL PHARMACOLOGY Atracurium besylate is a nondepolarizing skeletal muscle relaxant. Nondepolarizing agents antagonize the neurotransmitter action of acetylcholine by binding competitively with cholinergic receptor sites on the motor end-plate. This antagonism is inhibited, and neuromuscular…
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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.