NDAORALSOLUTION
Approved
Mar 1988
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
2
Data completeness
4/8 — Partial
IMODIUM A-D (loperamide hydrochloride) by Johnson & Johnson is mechanism of action in vitro and animal studies show that loperamide hydrochloride capsules act by slowing intestinal motility and by affecting water and electrolyte movement through the bowel. First approved in 1988.
Drug data last refreshed 23h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
IMODIUM A-D is an oral solution containing loperamide hydrochloride, a small-molecule antidiarrheal agent approved in 1988. It treats acute diarrhea by binding to opiate receptors in the gut wall, inhibiting acetylcholine and prostaglandin release to reduce intestinal motility and increase transit time. The drug increases anal sphincter tone, reducing incontinence and urgency.
LOE Approaching
As a mature OTC product approaching loss of exclusivity with moderate competitive pressure (30%), the brand team is likely focused on defensive market retention and cost management rather than expansion.
Mechanism of Action
Mechanism of Action In vitro and animal studies show that loperamide hydrochloride capsules act by slowing intestinal motility and by affecting water and electrolyte movement through the bowel. Loperamide binds to the opiate receptor in the gut wall. Consequently, it inhibits the release of…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (2)
A Study of Combination Caplet With Loperamide Hydrochloride and Simethicone, and Imodium Express Tablets-lyophilizate Coadministered With Espumisan Capsule in Healthy Volunteers
Started Dec 2019
48 enrolled
Healthy
Efficacy and Safety Study of Loperamide Hydrochloride/Simethicone Chewable Tablet in Treatment of Acute Diarrhea With Abdominal Discomfort and Flatulence
Started Jul 2005
217 enrolled
Diarrhea
Career Relevance
Working on IMODIUM A-D offers limited career growth opportunity as a mature, LOE-approaching OTC product with zero linked job openings. Roles are primarily focused on defending market share, managing generic competition, and optimizing cost structure rather than driving innovation or expansion.
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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.