NDAORALTABLET
Approved
Apr 2011
Lifecycle
Post-LOE
Competitive Pressure
35/100
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 Yesterday
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
DUEXIS is a fixed-dose combination tablet containing famotidine (an H2-receptor antagonist) and ibuprofen (an NSAID) approved in 2011. It reduces gastric acid secretion while providing anti-inflammatory pain relief, designed to protect the stomach while delivering analgesic benefit. The combination addresses NSAID-induced gastrointestinal injury in patients requiring chronic pain management.
$0.014BPart D
Post-LOEPost-LOEProduct is in mature/post-LOE phase with modest Part D spending (~$14M in 2023), suggesting a smaller commercial footprint and likely consolidated support team focused on retention rather than growth.
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.