NDAINTRAMUSCULAR, INTRAVENOUSSOLUTION
Approved
Oct 2013
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
2
Data completeness
4/8 — Partial
MORPHINE SULFATE (morphine sulfate) by Fresenius Kabi is mu-opioid receptor, although it can bind to other opioid receptors at higher doses. First approved in 2013.
Drug data last refreshed 12h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Morphine sulfate is a full mu-opioid receptor agonist indicated for pain management via intramuscular or intravenous administration. It works by binding to opioid receptors in the brain and spinal cord to block pain signal transmission, with no ceiling effect for analgesia. The drug is a solution formulation approved as a New Drug Application (NDA) by Fresenius Kabi.
Peak7.4 years to LOE
Peak lifecycle position suggests stable commercial operations and mature team structure with focus on market maintenance rather than expansion.
Mechanism of Action
mu-opioid receptor, although it can bind to other opioid receptors at higher doses. The principal therapeutic action of morphine is analgesia. Like all full opioid agonists, there is no ceiling effect for analgesia with morphine. Clinically, dosage is titrated to provide adequate analgesia and may…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (2)
Abuse Potential Assessment of Intranasally Administered EMBEDA Compared To Morphine Sulfate Controlled Release And Placebo
Started Aug 2010
33 enrolled
Narcotic AbuseOpioid-related DisordersAnalgesia+1 more
Study to Determine the Bioavailability, Pharmacodynamic Effects, and Safety of Whole and Crushed ALO-01 Compared to Morphine Sulfate Immediate Release (MSIR)
Started Mar 2007
32 enrolled
Healthy
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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.