NDAORALTABLET, CHEWABLE
Approved
Jul 1997
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
2
Data completeness
3/8 — Basic
IMODIUM A-D EZ CHEWS (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 1997.
Drug data last refreshed Yesterday
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
IMODIUM A-D EZ CHEWS is a chewable oral tablet formulation of loperamide hydrochloride, an antidiarrheal agent approved in 1997. It treats acute diarrhea by binding to opiate receptors in the gut wall, reducing intestinal motility and increasing water/electrolyte absorption. The mechanism involves inhibition of acetylcholine and prostaglandin release, increasing anal sphincter tone and reducing urgency.
LOE Approaching
As LOE approaches, the brand team is likely stabilizing commercial operations with reduced headcount; focus shifts from growth to lifecycle management and generic defense strategies.
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
This product offers limited career growth due to its mature, OTC lifecycle stage and approaching LOE; opportunities are concentrated in defending market share, optimizing retail distribution, and managing generic/private-label competition. Roles emphasize operational excellence and consumer marketing over innovation.
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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.