NDAORALTABLETPriority Review
Approved
Dec 1988
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
17
Data completeness
6/8 — Strong
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. Approved for postpartum hemorrhage, labor induction, cervical ripening. First approved in 1988.
Drug data last refreshed 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
CYTOTEC (misoprostol) is a prostaglandin E1 analog oral tablet approved in 1988 for prevention of NSAID-induced gastric ulcers and treatment of postpartum hemorrhage, labor induction, and cervical ripening. It works by binding to prostaglandin receptors to promote gastric mucosa protection and uterine contractions. The drug is indicated across obstetrics, rheumatology, and gastrointestinal protection, with significant off-label use globally.
$0.033MPart D
LOE ApproachingMinimal commercial investment signals a legacy product in decline with limited team expansion; roles focus on compliance and managed care rather than growth.
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…
Worked on CYTOTEC at Pfizer? Share your interview experience or compensation data (+7 days Pro)
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.