NDAORALTABLETPriority Review
Approved
Dec 1988
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
17
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 1h 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 NSAID-induced gastric ulcer prevention and treatment. It works by reducing gastric acid secretion and enhancing mucosal protective mechanisms. This small molecule is rapidly absorbed and metabolized, with clinical activity driven by its free acid form.
$0.033BPart D
LOE ApproachingProduct approaching loss of exclusivity with minimal market penetration (45 Part D claims in 2023), indicating a contracting brand team and limited growth opportunity.
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.