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 2d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
PROMETRIUM is an oral micronized progesterone capsule that is chemically identical to naturally occurring ovarian progesterone. It is indicated for hormone replacement therapy, contraception, and treatment of conditions including infertility, endometrial hyperplasia, preterm birth prevention, and multiple other gynecological and neurological conditions. The drug works by binding to progesterone receptors to modulate hormonal signaling and reproductive/metabolic processes.
$0.277MPart D
LOE ApproachingAs a product approaching loss of exclusivity with minimal Part D spending, the brand team is likely focused on cost management and efficiency rather than significant commercial expansion.
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.