NDAORALTABLET
Approved
Dec 1995
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
1
Data completeness
3/8 — Basic
ZANTAC 75 (ranitidine hydrochloride) by Sanofi. Approved for hiv infection. First approved in 1995.
Drug data last refreshed 1w ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ZANTAC 75 (ranitidine hydrochloride) is an oral tablet indicated for HIV infection, approved in 1995 as an NDA by Sanofi. The mechanism of action and pharmacologic class are not specified in available data, suggesting this indication may represent off-label or historical use. The product is approaching loss of exclusivity.
LOE Approaching
With LOE approaching and zero linked job count, ZANTAC 75 is in portfolio decline with minimal active commercial infrastructure and limited career expansion opportunities.
Mechanism of Action
Mechanism of action data is being enriched from DailyMed and FDA sources. Check back soon for updated drug intelligence.
Clinical Trials (1)
Bioavailability Study of Ranitidine Hydrochloride (Maximum Strength ZANTAC 150®) Compared to Two Different 150 mg Ranitidine Hydrochloride Oral Disintegrating Tablet (ODT) in Fasting, Healthy Male Volunteers
Started May 2009
42 enrolled
Healthy
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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.