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 48m ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Tylenol (acetaminophen) is an over-the-counter analgesic and antipyretic available as an oral extended-release tablet. It works primarily through central nervous system mechanisms to reduce pain and fever, with a well-established safety profile across pediatric and adult populations. The drug has no antiplatelet or anticoagulant effects and is widely used for mild-to-moderate pain management.
LOE Approaching
As LOE approaches, the brand team will shift focus from growth initiatives to lifecycle management and cost containment strategies, with smaller headcount requirements.
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…
Worked on TYLENOL at Gland Pharma? Share your interview experience or compensation data (+7 days Pro)
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.