NDAORALCAPSULE
Approved
Dec 2005
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
3/8 — Basic
ADVIL PM (diphenhydramine hcl, ibuprofen) by GSK is cyclooxygenase inhibitors [moa]. First approved in 2005.
Drug data last refreshed Yesterday · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ADVIL PM is a fixed-dose combination of ibuprofen (NSAID) and diphenhydramine HCl (antihistamine) delivered as an oral capsule for over-the-counter use. It combines cyclooxygenase inhibition for pain/inflammation relief with antihistamine-induced sedation to promote sleep. The product targets consumers seeking nighttime pain relief with sleep aid benefits.
LOE Approaching
Product is transitioning toward loss of exclusivity with moderate competitive pressure (30/100), signaling potential team consolidation or pivot to generic optimization strategies.
Mechanism of Action
Cyclooxygenase Inhibitors
Pharmacologic Class:
Nonsteroidal Anti-inflammatory Drug
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Career Relevance
Working on ADVIL PM offers experience in OTC portfolio management, retail channel strategy, and post-LOE brand defense in a highly competitive consumer health space. Career growth is limited to commercial and operational functions, with minimal clinical or innovation-focused development pathways.
Brand ManagerOTC Marketing Manager
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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.