NDAINJECTIONINJECTABLEPriority Review
Approved
Sep 1984
Lifecycle
LOE Approaching
Competitive Pressure
60/100
Clinical Trials
2
Data completeness
5/8 — Partial
Priority Review
INFUMORPH (morphine sulfate) by Hikma is mu-opioid receptor, although it can bind to other opioid receptors at higher doses. Approved for pain, chronic pain, cancer pain and 1 more indications. First approved in 1984.
Drug data last refreshed 19h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
INFUMORPH is a morphine sulfate injectable formulation approved in 1984 for acute and chronic pain management, including cancer and postoperative pain. It is a full mu-opioid receptor agonist with no ceiling effect for analgesia, though dosing is limited by adverse effects including respiratory and CNS depression. The drug's analgesic mechanism involves CNS opioid receptors in the brain and spinal cord.
LOE Approaching
Product is approaching loss of exclusivity with moderate competitive pressure (60/100), signaling potential team consolidation and transition focus toward managed care and cost-containment strategies.
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.