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 7h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
LOMOTIL is an oral small-molecule antidiarrheal combining diphenoxylate hydrochloride and atropine sulfate, approved in 1960. It reduces diarrhea by enhancing segmentation and prolonging gastrointestinal transit time through direct effects on bowel smooth muscle. The drug is indicated for symptomatic relief of acute and chronic diarrhea in patients who require pharmacologic management.
LOE Approaching
As a mature product approaching loss of exclusivity with moderate competitive pressure (30%), the brand team is likely consolidating and preparing for generic erosion rather than expanding.
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.