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 9h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
LOMOTIL is a combination antidiarrheal agent containing diphenoxylate hydrochloride and atropine sulfate, indicated for the symptomatic treatment of diarrhea in adults. Diphenoxylate acts directly on circular smooth muscle of the bowel to enhance segmentation and prolong gastrointestinal transit time, while atropine provides anticholinergic activity. The drug is rapidly metabolized to its active metabolite diphenoxylic acid with a half-life of 12–14 hours.
$0.218MPart D
LOE ApproachingDeclining revenue and aging asset approaching loss of exclusivity signals consolidation of brand support and transition to generic stewardship roles.
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.