NDAORALTABLETPriority Review
Approved
Sep 1960
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
3/8 — Basic
Priority ReviewSchedule 5
LOMOTIL (diphenoxylate hydrochloride and atropine sulfate) by Pfizer is clinical pharmacology diphenoxylate is rapidly and extensively metabolized in man by ester hydrolysis to diphenoxylic acid (difenoxine), which is biologically active and the major metabolite in the blood. First approved in 1960.
Drug data last refreshed 18h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
LOMOTIL is an oral antidiarrheal combination containing diphenoxylate hydrochloride and atropine sulfate, approved in 1960. It reduces diarrhea by enhancing intestinal segmentation and prolonging gastrointestinal transit time through direct effects on bowel smooth muscle. The product is indicated for symptomatic relief of acute and chronic diarrhea.
LOE Approaching
Product is approaching loss of exclusivity with moderate competitive pressure (30/100), signaling potential team consolidation or transition planning.
Mechanism of Action
CLINICAL PHARMACOLOGY Diphenoxylate is rapidly and extensively metabolized in man by ester hydrolysis to diphenoxylic acid (difenoxine), which is biologically active and the major metabolite in the blood. After a 5 mg oral dose of carbon-14 labeled diphenoxylate hydrochloride in ethanolic solution…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
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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.