NDAORALTABLET
Approved
Jul 1978
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
2/8 — Basic
MOTOFEN HALF-STRENGTH (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 1h ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
MOTOFEN HALF-STRENGTH is an oral antidiarrheal tablet containing difenoxin (the active metabolite of diphenoxylate) combined with atropine sulfate. It slows intestinal motility through local effects on the gastrointestinal wall to treat acute diarrhea. The drug is rapidly absorbed with peak plasma levels within 40–60 minutes and is metabolized to inactive conjugates excreted in urine and feces.
LOE Approaching
Product is in late-stage lifecycle with moderate competitive pressure (30%); brand teams should anticipate resource reallocation toward LOE mitigation and generic transition planning.
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 HALF-STRENGTH offers limited career growth due to LOE approaching and zero linked job count, indicating minimal ongoing hiring. Roles focus on managing decline, transitioning to generic support, or defending market share against competitors rather than expansion or 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.