NDAORALTABLETPriority Review
Approved
Dec 1988
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
18
Data completeness
5/8 — Partial
Priority Review
CYTOTEC (misoprostol) by Pfizer is clinical pharmacology pharmacokinetics misoprostol is extensively absorbed, and undergoes rapid de-esterification to its free acid, which is responsible for its clinical activity and, unlike the parent compound, is detectable in plasma. First approved in 1988.
Drug data last refreshed 5h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CYTOTEC (misoprostol) is an oral prostaglandin E1 analog approved in 1988 for gastrointestinal protection, primarily used to prevent NSAID-induced ulcers. It works by reducing gastric acid secretion and enhancing mucosal defense mechanisms. The drug is also widely used off-label for obstetric indications including labor induction and medical abortion.
$0.033BPart D
LOE ApproachingDeclining
LOE approaching signals transition from maintenance mode to managed decline; commercial team is likely consolidating resources and preparing for generic erosion.
Mechanism of Action
CLINICAL PHARMACOLOGY Pharmacokinetics Misoprostol is extensively absorbed, and undergoes rapid de-esterification to its free acid, which is responsible for its clinical activity and, unlike the parent compound, is detectable in plasma. The alpha side chain undergoes beta oxidation and the beta…
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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.