NDARECTALSUPPOSITORY
Approved
Feb 1978
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
ACEPHEN (acetaminophen) by Gland Pharma is 12. Approved for mild to moderate pain in adult, older () management of moderate to severe pain with adjunctive opioid analgesics in adult, older () reduction of fever in adult. First approved in 1978.
Drug data last refreshed Yesterday · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ACEPHEN is a rectal suppository formulation of acetaminophen, a well-established analgesic and antipyretic agent. It is indicated for mild to moderate pain, moderate to severe pain as an opioid adjunct, and fever reduction in adults and older patients. The mechanism involves primarily central analgesic and antipyretic actions, though the precise pathway remains incompletely characterized.
LOE Approaching
As a mature, LOE-approaching product with limited patent protection, the ACEPHEN brand team faces resource constraints and declining headcount, with emphasis shifting toward operational efficiency and supply chain management rather than growth initiatives.
Mechanism of Action
12.1 Mechanism of Action The precise mechanism of the analgesic and antipyretic properties of acetaminophen is not established but is thought to primarily involve central actions. 12.2 Pharmacodynamics Acetaminophen has been shown to have analgesic and antipyretic activities in animal and human…
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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.