NDAORALSOLUTION
Approved
Jun 2011
Lifecycle
Peak
Competitive Pressure
30/100
Data completeness
3/8 — Basic
CODEINE SULFATE (codeine sulfate) by Hikma is mu-opioid receptor, but with a much weaker affinity than morphine. Approved for mild to moderate pain, where treatment with an opioid is appropriate, for which alternative treatments are inadequate. First approved in 2011.
Drug data last refreshed 4h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Codeine sulfate is an oral solution containing codeine, a weak mu-opioid receptor agonist used for mild to moderate pain where alternative treatments are inadequate. The analgesic properties are believed to derive from conversion to morphine, though the exact mechanism remains incompletely understood. It represents a foundational opioid therapy option in the pain management armamentarium.
Peak
Product is at peak lifecycle maturity as an NDA-approved generic-equivalent oral solution from Hikma; team likely focused on market maintenance and margin protection rather than growth initiatives.
Mechanism of Action
mu-opioid receptor, but with a much weaker affinity than morphine. The analgesic properties of codeine have been speculated to come from its conversion to morphine, although the exact mechanism of analgesic action remains unknown.
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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.