NDAINJECTIONINJECTABLEPriority Review
Approved
Sep 1984
Lifecycle
LOE Approaching
Competitive Pressure
60/100
Clinical Trials
2
Data completeness
3/8 — Basic
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.
Drug data last refreshed 3h ago · AI intelligence enriched 5d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
DURAMORPH PF is a preservative-free injectable morphine sulfate formulation approved in 1984 for pain management via injection. As an opioid agonist, it binds to mu-opioid receptors in the central nervous system to provide potent analgesia. It is primarily used in acute and chronic pain settings, including perioperative and cancer pain management.
LOE Approaching
Product is approaching loss of exclusivity with moderate competitive pressure (60%), indicating team restructuring and focus shift toward managed decline or niche positioning.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
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
Career Relevance
Working on DURAMORPH PF offers limited growth trajectory due to LOE approaching status and current supply shortage, making it suitable for professionals interested in portfolio maintenance, regulatory navigation, or cost-containment strategies. Positions on this product typically involve managing decline, ensuring compliance, and optimizing operational efficiency rather than driving market expansion.
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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.