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 22h ago · AI intelligence enriched 3d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
MOTOFEN is an oral antidiarrheal combination product containing difenoxin (the active metabolite of diphenoxylate) and atropine sulfate. It reduces diarrhea by slowing intestinal motility through local effects on the gastrointestinal wall. This is an adjunct therapy for symptomatic relief of acute diarrhea.
$0.616MPart D
LOE ApproachingMinimal commercial activity with only 654 Part D claims in 2023 suggests a niche, legacy product with a very small team focused on maintenance rather than growth.
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 limited career trajectory as it is a legacy, niche product with minimal commercial activity and no clinical development pipeline. Roles would focus on regulatory maintenance, compliance, and managing a declining patient base rather than innovation or growth.
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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.