NDAORALTABLET
Approved
Jul 1978
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
3/8 — Basic
MOTOFEN (difenoxin and atropine sulfate) by Enterprise Therapeutics is clinical pharmacology animal studies have shown that difenoxin hydrochloride manifests its antidiarrheal effect by slowing intestinal motility. First approved in 1978.
Drug data last refreshed 20h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
MOTOFEN is an oral antidiarrheal combination tablet containing difenoxin (the active metabolite of diphenoxylate) and atropine sulfate, approved in 1978. It works by slowing intestinal motility through a local effect on the gastrointestinal wall. The product is indicated for acute diarrhea management in patients who require pharmacologic intervention.
$0.616MPart D
LOE ApproachingMinimal Part D uptake signals a legacy product with contracted commercial footprint and likely limited team expansion opportunities.
Mechanism of Action
CLINICAL PHARMACOLOGY Animal studies have shown that difenoxin hydrochloride manifests its antidiarrheal effect by slowing intestinal motility. The mechanism of action is by a local effect on the gastrointestinal wall. Difenoxin is the principal active metabolite of diphenoxylate. Following oral…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Career Relevance
Working on MOTOFEN offers stability in a mature, low-risk portfolio but minimal growth trajectory or skill-building in emerging modalities. Roles are primarily operational, focused on maintaining market presence and managing generic competition rather than 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.