NDAORALTABLET, CHEWABLE, TABLET, CAPSULE
Approved
Aug 1996
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
2/8 — Basic
HELIDAC (bismuth subsalicylate; metronidazole; tetracycline hydrochloride) by R-Pharm US. Approved for travelers' diarrhea diarrhea upset stomach due to overindulgence in food, drink, including: heartburn indigestion nausea gas belching fullness. First approved in 1996.
Drug data last refreshed 2d ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
HELIDAC is a fixed-dose combination tablet containing bismuth subsalicylate, metronidazole, and tetracycline hydrochloride, approved in 1996 for treatment of travelers' diarrhea and gastrointestinal upset. The combination works through antimicrobial and anti-inflammatory mechanisms to address infectious and functional GI symptoms including heartburn, indigestion, nausea, and gas. This is a mature oral small-molecule product in the over-the-counter and prescription gastrointestinal market.
LOE Approaching
Product is approaching loss of exclusivity with moderate competitive pressure (30/100), suggesting consolidating team size and transition focus toward generic transition planning.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
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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.