NDAORALTABLET
Approved
Jul 2009
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
5/8 — Partial
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 2009.
Drug data last refreshed 13h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Codeine sulfate is an oral tablet small-molecule opioid agonist approved in 2009 for mild to moderate pain where alternative treatments are inadequate. It binds weakly to mu-opioid receptors with analgesic properties speculated to derive from conversion to morphine, though the exact mechanism remains unknown.
$0.241MPart D
LOE ApproachingLimited commercial opportunity as product approaches loss of exclusivity with minimal market claims relative to competitors.
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.