NDAORALTABLET2 Generics Approved
Approved
Mar 2008
Lifecycle
LOE Approaching
Competitive Pressure
60/100
Clinical Trials
2
Data completeness
2/8 — Basic
Drug data last refreshed 15h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Morphine sulfate is a Schedule II opioid analgesic available as an oral tablet formulation, approved by FDA in 2008 under Hikma's NDA. It is indicated for moderate to severe pain management in opioid-tolerant and opioid-naive patients. The drug works as a mu-opioid receptor agonist to provide rapid pain relief.
LOE Approaching
As a mature, approaching-LOE opioid product, the commercial team is likely smaller and focused on defensive positioning against generic/branded competitors rather than growth initiatives.
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 morphine sulfate offers limited career growth given its approaching LOE and mature market position; roles are primarily defensive and focused on managed care negotiations, generic defense, and operational efficiency. This is a stable but non-growth opportunity best suited for professionals with expertise in pain management markets or seeking transition into a lower-stress commercial role.
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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.