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 23h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
MOTOFEN is an oral antidiarrheal tablet containing difenoxin and atropine sulfate, approved in 1978. Difenoxin, the active metabolite of diphenoxylate, slows intestinal motility through local effects on the gastrointestinal wall to treat acute diarrhea. The formulation includes atropine as an anticholinergic adjunct to discourage abuse.
$0.616MPart D
LOE ApproachingDeclining
Mature product with minimal growth potential and likely small dedicated team focused on maintenance and compliance.
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
MOTOFEN shows minimal career opportunity with zero linked job openings and approaching loss of exclusivity. This product is suited only for niche regulatory, compliance, or supply chain roles within a maintenance-focused small team.
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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.