NDAORALSOLUTIONPriority Review
Approved
Oct 1961
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
4/8 — Partial
Priority Review
LOMOTIL (atropine sulfate; diphenoxylate hydrochloride) 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. Approved for older for: atropine is an anticholinergic agent indicated in adults, older for: cycloplegia () mydriasis () penalization of the healthy eye in the treatment of amblyopia () 1. First approved in 1961.
Drug data last refreshed 12h ago · AI intelligence enriched 5d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Lomotil is an oral antidiarrheal combination of diphenoxylate hydrochloride and atropine sulfate approved since 1961. Diphenoxylate acts on circular smooth muscle of the bowel to increase segmentation and prolong gastrointestinal transit time, while atropine provides anticholinergic activity. It is indicated for symptomatic relief of diarrhea in adults.
$0.218MPart D
LOE ApproachingLegacy product with declining claims volume and no active brand investment signals; brand team likely in maintenance mode with minimal headcount expansion.
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 (2)
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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.