NDAORALTABLET, EXTENDED RELEASE
Approved
Jun 1994
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
3/8 — Basic
TYLENOL (acetaminophen) by Gland Pharma is 12. First approved in 1994.
Drug data last refreshed 17h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Tylenol (acetaminophen) is an oral analgesic and antipyretic available in extended-release tablet form that works primarily through central nervous system mechanisms to reduce pain and fever. It is one of the most widely used over-the-counter pain relievers globally, indicated for mild-to-moderate pain and fever across diverse patient populations.
LOE Approaching
As LOE approaches, the brand team is likely focused on lifecycle extension strategies and cost optimization rather than growth initiatives, signaling potential team consolidation.
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.