NDAORALTABLET
Approved
Apr 2011
Lifecycle
LOE Approaching
Competitive Pressure
25/100
Clinical Trials
1
Data completeness
5/8 — Partial
DUEXIS (famotidine; ibuprofen) by Amgen is histamine-2 (h2) receptors. First approved in 2011.
Drug data last refreshed 9h ago · AI intelligence enriched 5d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
DUEXIS is a fixed-dose oral combination tablet containing famotidine (an H2-receptor antagonist) and ibuprofen (an NSAID), designed to reduce gastric acid secretion while providing anti-inflammatory pain relief. It is indicated for patients requiring NSAID therapy who are at risk of NSAID-induced gastric ulcers. Famotidine inhibits gastric acid production by blocking histamine-2 receptors, protecting the stomach lining from NSAID-induced damage.
$0.014BPart D
LOE Approaching1mo to LOEWith only ~5,500 annual Part D claims and LOE arriving in mid-2026, this product is a declining niche brand requiring defensive commercial strategy and minimal team expansion.
Mechanism of Action
histamine-2 (H2) receptors. The primary clinically important pharmacologic activity of famotidine is inhibition of gastric secretion. Both the acid concentration and volume of gastric secretion are suppressed by famotidine, while changes in pepsin secretion are proportional to volume output.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (1)
Open-label Safety and Pharmacokinetic Study of DUEXIS® (Ibuprofen and Famotidine) Tablets in Juvenile Idiopathic Arthritis
Started Apr 2012
12 enrolled
Juvenile Idiopathic Arthritis
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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.