NDAINJECTIONINJECTABLEPriority Review
Approved
Sep 1984
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
2
Data completeness
4/8 — Partial
Priority Review
Drug Shortage Active
DURAMORPH PF is currently in shortage. Reason: Unavailable. This may impact manufacturing, supply chain, and quality hiring at the manufacturer.
DURAMORPH PF (morphine sulfate) by Hikma is mu-opioid receptor, although it can bind to other opioid receptors at higher doses. First approved in 1984.
Drug data last refreshed 18h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
DURAMORPH PF is a parenteral morphine sulfate injection approved in 1984 for moderate to severe pain management. It is a full mu-opioid receptor agonist that provides analgesia without a ceiling effect, with dosing titrated to patient response and tolerability.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30/100), signaling potential team restructuring and transition focus.
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.