NDAORALTABLET
Approved
Apr 1995
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
3/8 — Basic
PEPCID AC (famotidine) by Dr. Reddy's Laboratories is histamine h2 receptor antagonists [moa]. First approved in 1995.
Drug data last refreshed 20h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
PEPCID AC (famotidine) is an over-the-counter histamine H2 receptor antagonist oral tablet used to prevent and relieve heartburn, acid indigestion, and sour stomach. It works by reducing acid production in the stomach to provide symptomatic relief of acid-related conditions.
LOE Approaching
As an established OTC product facing approaching loss of exclusivity, the brand team is likely focused on defensive positioning and cost management rather than growth initiatives.
Mechanism of Action
Histamine H2 Receptor Antagonists
Pharmacologic Class:
Histamine-2 Receptor Antagonist
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Study on the Effect of Famotidine on Pharmacokinetics of Taletrectinib
Started Aug 2026
56 enrolled
Healthy Adult Participants
Evaluate the Effects of Famotidine or Rabeprazole on the PK of Nirogacestat
Started Aug 2025
24 enrolled
Healthy
A Study to Assess the Effect of Famotidine on the Drug Levels of Afimetoran in Healthy Participants
Started Jul 2023
32 enrolled
Healthy Volunteers
A Study to Determine the Effect of Famotidine on the Drug Levels of BMS-986256 in Healthy Participants
Started Jun 2021
22 enrolled
Healthy Participants
Study to Assess the Effect of Acid-reducing Agent Famotidine on the Drug Levels of BMS-986256 in Healthy Participants
Started Jul 2020
35 enrolled
Healthy Participants
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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.