NDAORALTABLET
Approved
Aug 1999
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
3/8 — Basic
PEPCID AC (famotidine) by Johnson & Johnson is histamine h2 receptor antagonists [moa]. First approved in 1999.
Drug data last refreshed Yesterday
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
PEPCID AC (famotidine) is an oral histamine H2 receptor antagonist approved in 1999 for treating gastroesophageal reflux disease, heartburn, and peptic ulcer disease. It works by blocking histamine-mediated gastric acid secretion, reducing stomach acid production. The product is available as an over-the-counter tablet formulation.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30%), indicating potential portfolio contraction and team restructuring ahead.
Mechanism of Action
Histamine H2 Receptor Antagonists
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
76 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.