NDARECTALSUPPOSITORY
Approved
Apr 1980
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
ACETAMINOPHEN (acetaminophen) by Gland Pharma is 12. First approved in 1980.
Drug data last refreshed 9h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Acetaminophen is a widely-used over-the-counter analgesic and antipyretic available in rectal suppository formulation, sponsored by Gland Pharma. The drug's precise mechanism remains incompletely understood but is thought to involve central nervous system actions for pain relief and fever reduction. It is used across diverse patient populations for mild-to-moderate pain and fever management.
LOE Approaching
As an approaching loss-of-exclusivity product in a mature market with high competitive pressure (30/100), the brand team will likely focus on niche formulations and cost 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.