NDAOralTablet, Delayed Release
Approved
Nov 2002
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
13
Data completeness
4/8 — Partial
ACIPHEX (rabeprazole sodium) by Eisai is (substituted benzimidazole proton-pump inhibitors) that do not exhibit anticholinergic or histamine h 2 -receptor antagonist properties, but suppress gastric acid secretion by inhibiting the gastric h, katpase at the secretory surface of the gastric parietal cell. First approved in 2002.
Drug data last refreshed 16h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ACIPHEX (rabeprazole sodium) is an oral delayed-release proton-pump inhibitor that suppresses gastric acid secretion by inhibiting the H+/K+-ATPase enzyme at the gastric parietal cell secretory surface. It is indicated for acid-reflux disorders including GERD, peptic ulcer disease, and related conditions. The drug works by blocking the final step of gastric acid secretion through pH-dependent activation and formation of an active sulfenamide that irreversibly inhibits the acid pump.
$16MPart D
LOE ApproachingWith lifecycle approaching loss of exclusivity and modest Part D spending of $16M in 2023, the ACIPHEX brand team is in defensive mode, likely focused on market retention and cost management rather than expansion initiatives.
Mechanism of Action
(substituted benzimidazole proton-pump inhibitors) that do not exhibit anticholinergic or histamine H 2 -receptor antagonist properties, but suppress gastric acid secretion by inhibiting the gastric H, KATPase at the secretory surface of the gastric parietal cell. Because this enzyme is regarded as…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (13)
Study to Evaluate the Effect of Rabeprazole Sodium Enteric-coated Tablets on the Pharmacokinetics of TQ05105 Tablets
Started Jun 2026
16 enrolled
Myelofibrosis
Efficacy and Safety After Multiple Doses of TNP-2198 Capsules, Rabeprazole Sodium Enteric-coated Tablets and Amoxicillin Capsules in Helicobacter Pylori Infected-positive Participants
Started Jun 2022
80 enrolled
Helicobacter Pylori Infection
A Study to Evaluate Preliminary Helicobacter Pylori Eradication After Multiple Doses of TNP-2198 Capsules Combined With Rabeprazole Sodium Enteric-coated Tablets, or Rabeprazole Sodium Enteric-coated Tablets and Amoxicillin Capsules
Started Sep 2021
40 enrolled
Helicobacter Pylori Infection
The Safety and Tolerability, Pharmacokinetics of TNP-2092 Capsules in Combination With Rabeprazole Sodium Enteric-coated Tablets
Started Oct 2017
20 enrolled
Helicobacter Pylori Infection
The Study to Evaluate Efficacy and Safety of Newrabell® Tab.(Rabeprazole Sodium) 10mg b.i.d in Refractory GERD
Started Apr 2013
39 enrolled
Reflux Esophagitis
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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.