NDAINJECTIONINJECTABLE
Approved
Mar 1993
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
1
Data completeness
3/8 — Basic
NALBUPHINE HYDROCHLORIDE (nalbuphine hydrochloride) by AbbVie is clinical pharmacology mechanism of action nalbuphine is an agonist at kappa opioid receptors and an antagonist at mu opioid receptors. First approved in 1993.
Drug data last refreshed 9h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Nalbuphine hydrochloride is a mixed opioid agonist-antagonist injection approved in 1993 for potent analgesia. It acts as a kappa opioid receptor agonist and mu opioid receptor antagonist, providing morphine-equivalent analgesia up to 30 mg with a built-in ceiling effect on respiratory depression. Used primarily for moderate to severe pain management in perioperative and acute care settings.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30/100) suggests defensive positioning and team consolidation focus.
Mechanism of Action
CLINICAL PHARMACOLOGY Mechanism of Action Nalbuphine is an agonist at kappa opioid receptors and an antagonist at mu opioid receptors. Pharmacodynamics Nalbuphine hydrochloride injection is a potent analgesic. Its analgesic potency is essentially equivalent to that of morphine on a milligram basis…
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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.