NDAORALCAPSULE
Approved
Dec 1998
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
PROMETRIUM (progesterone) by Fresenius Kabi is clinical pharmacology prometrium capsules are an oral dosage form of micronized progesterone which is chemically identical to progesterone of ovarian origin. First approved in 1998.
Drug data last refreshed 3h ago · AI intelligence enriched 4d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
PROMETRIUM is an oral micronized progesterone capsule that is chemically identical to ovarian progesterone, used primarily for hormone replacement therapy and menstrual cycle regulation in postmenopausal women. The drug works by mimicking natural progesterone to restore hormonal balance and reduce vasomotor symptoms. Micronization increases oral bioavailability, with peak serum concentrations reached within 1.5–2.3 hours.
$0.277MPart D
LOE ApproachingMinimal Part D uptake and approaching loss of exclusivity signal a mature, stable product with limited growth trajectory and lean commercial infrastructure.
Mechanism of Action
CLINICAL PHARMACOLOGY PROMETRIUM Capsules are an oral dosage form of micronized progesterone which is chemically identical to progesterone of ovarian origin. The oral bioavailability of progesterone is increased through micronization. Pharmacokinetics A. Absorption After oral administration of…
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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.