NDAINJECTIONINJECTABLEPriority Review
Approved
Aug 1978
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
3/8 — Basic
Priority Review
STADOL (butorphanol tartrate) by Bristol Myers Squibb is mechanism of action butorphanol is a partial opioid agonist at the mu opioid receptor and a full agonist at the kappa opioid receptor. Approved for pain severe enough to require an opioid analgesic, for which alternative treatments are inadequate. First approved in 1978.
Drug data last refreshed 14h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
STADOL (butorphanol tartrate) is an injectable opioid analgesic approved in 1978 for severe pain management when alternative treatments are inadequate. It functions as a partial agonist at mu opioid receptors and full agonist at kappa receptors, providing analgesia through central nervous system mechanisms. The drug is administered via injection and is primarily used in acute care and perioperative settings.
LOE Approaching
Approaching loss of exclusivity with moderate competitive pressure (30/100); Bristol Myers Squibb likely consolidating brand maintenance teams as patent protection weakens.
Mechanism of Action
Mechanism of Action Butorphanol is a partial opioid agonist at the mu opioid receptor and a full agonist at the kappa opioid receptor. The principal therapeutic action of butorphanol is analgesia. Clinically, dosage is titrated to provide adequate analgesia and may be limited by adverse reactions,…
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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.