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 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Codeine sulfate is an oral tablet opioid analgesic indicated for mild to moderate pain where treatment with an opioid is appropriate and alternative treatments are inadequate. It acts as a weak mu-opioid receptor agonist, with analgesic properties thought to derive partly from conversion to morphine, though the exact mechanism remains unclear.
$0.241MPart D
LOE ApproachingProduct is approaching loss of exclusivity with minimal Part D spending, indicating limited commercial momentum and likely team downsizing or consolidation.
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.
Worked on CODEINE SULFATE at Hikma? Share your interview experience or compensation data (+7 days Pro)
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.