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 4d ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
Lomotil is a fixed-dose combination of diphenoxylate hydrochloride (an opioid-like antidiarrheal) and atropine sulfate (an anticholinergic), approved in 1961 for oral treatment of diarrhea. Diphenoxylate is rapidly metabolized to diphenoxylic acid, which acts on circular smooth muscle of the bowel to increase segmentation and prolong gastrointestinal transit time. The atropine component serves as a deterrent to abuse.
$0.218MPart D
LOE ApproachingLomotil is approaching loss of exclusivity with minimal Part D utilization (614 claims in 2023), indicating a mature, stable brand with likely small supporting team.
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.