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 8h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
PEPCID AC (famotidine) is an oral H2-receptor antagonist that reduces gastric acid production by blocking histamine signaling in the stomach. It is indicated for the treatment and prevention of heartburn, acid indigestion, and gastric ulcers. The drug works by competitively inhibiting histamine H2 receptors on parietal cells, thereby decreasing acid secretion.
LOE Approaching
As LOE approaches, the brand team is likely focused on lifecycle extension, generic defense, and transition planning 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)
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
A Study in Healthy Male Subjects to Investigate the Effect of Famotidine and Efavirenz on the Way the Body Takes up, Distributes, and Gets Rid of Daridorexant.
Started May 2020
24 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.