NDAORALTABLET, CHEWABLE
Approved
Dec 1983
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
2
Data completeness
3/8 — Basic
GAVISCON (aluminum hydroxide; magnesium trisilicate) by Sanofi. Approved for heartburn acid indigestion sour stomach upset stomach associated with these symptoms. First approved in 1983.
Drug data last refreshed 2d ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Gaviscon is an oral antacid combination of aluminum hydroxide and magnesium trisilicate approved in 1983 for relief of heartburn, acid indigestion, sour stomach, and associated upset stomach symptoms. It works through direct neutralization of gastric acid. The chewable tablet formulation provides rapid symptomatic relief in the OTC antacid market.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30), indicating potential team restructuring and shift toward generic or brand transition strategies.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Clinical Trials (2)
PH Metry Study to Compare the Antacid Activity of Z0063 Versus Gaviscon Double Action Tablets, in Healthy Adult Subjects
Started Feb 2017
24 enrolled
Gastroesophageal Reflux Disease
Scintigraphy Study to Compare the Antireflux Activity of the Z0063 Versus Gaviscon Double Action Tablets, in Healthy Adult Subjects
Started Feb 2017
34 enrolled
Gastroesophageal Reflux Disease
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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.