NDAINJECTIONINJECTABLEPriority Review
Approved
Sep 1984
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
2
Data completeness
5/8 — 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. Approved for pain, chronic pain, postoperative pain and 1 more indications. First approved in 1984.
Drug data last refreshed Yesterday · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
DURAMORPH PF is a parenteral formulation of morphine sulfate, a full mu-opioid receptor agonist indicated for acute and chronic pain management including postoperative and cancer pain. It works by binding to opioid receptors in the central nervous system to produce analgesia without a ceiling effect on pain relief.
LOE Approaching
Product is approaching loss of exclusivity with moderate competitive pressure (30/100), signaling potential team rationalization and shift toward defensive positioning.
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 (4)
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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.