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 18h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Nalbuphine hydrochloride is a mixed opioid agonist-antagonist injectable analgesic approved in 1993 for moderate to severe pain management. It acts as a kappa opioid receptor agonist while antagonizing mu opioid receptors, providing analgesic potency equivalent to morphine up to 30 mg with a built-in ceiling effect on respiratory depression. This dual mechanism differentiates it from pure mu agonists and reduces abuse potential.
LOE Approaching
Product approaching loss of exclusivity with limited commercial expansion; teams are typically focused on maximizing remaining patent-protected revenue and preparing for generic competition.
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.