NDAORALTABLET
Approved
Jan 1994
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
47
Data completeness
5/8 — Partial
ALEVE (naproxen sodium) by Bayer is analgesic, anti-inflammatory, and antipyretic properties. Approved for migraine, pain, postoperative pain and 2 more indications. First approved in 1994.
Drug data last refreshed 19h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ALEVE (naproxen sodium) is an oral NSAID tablet approved in 1994 that provides analgesic, anti-inflammatory, and antipyretic effects through COX-1/COX-2 inhibition and prostaglandin synthesis suppression. It is indicated for migraine, pain, postoperative pain, dysmenorrhea, and osteoarthritis across diverse patient populations.
LOE Approaching
As LOE approaches, marketing teams face declining market exclusivity and should prepare for generic competition mitigation strategies; team stability may depend on line extensions or differentiation initiatives.
Mechanism of Action
analgesic, anti-inflammatory, and antipyretic properties. The mechanism of action of naproxen, like that of other NSAIDs, is not completely understood but involves inhibition of cyclooxygenase (COX-1 and COX-2). Naproxen sodium is a potent inhibitor of prostaglandin synthesis in vitro . Naproxen…
Indications (5)
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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.