NDAORALTABLET
Approved
Dec 1980
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
1
Data completeness
4/8 — Partial
REGLAN (metoclopramide hydrochloride) by ANI Pharmaceuticals is clinical pharmacology metoclopramide stimulates motility of the upper gastrointestinal tract without stimulating gastric, biliary, or pancreatic secretions. First approved in 1980.
Drug data last refreshed 16h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
REGLAN (metoclopramide HCl) is an oral small-molecule dopamine antagonist approved in 1980 for gastrointestinal motility disorders and nausea/vomiting. It works by sensitizing GI tissues to acetylcholine and blocking dopamine receptors in the chemoreceptor trigger zone, accelerating gastric emptying and increasing lower esophageal sphincter pressure. It is primarily used in gastroesophageal reflux disease, diabetic gastroparesis, and post-operative nausea.
$0.088BPart D
LOE ApproachingDeclining
With loss of exclusivity approaching and modest Part D spending ($88K, 155 claims in 2023), the brand team is likely small and focused on generic competition mitigation rather than growth initiatives.
Mechanism of Action
CLINICAL PHARMACOLOGY Metoclopramide stimulates motility of the upper gastrointestinal tract without stimulating gastric, biliary, or pancreatic secretions. Its mode of action is unclear. It seems to sensitize tissues to the action of acetylcholine. The effect of metoclopramide on motility is not…
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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.