NDAORALTABLET
Approved
Oct 1999
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
4/8 — Partial
PREFEST (estradiol; norgestimate) by Teva is characteristics. Approved for moderate to severe vasomotor symptoms due to menopause (). First approved in 1999.
Drug data last refreshed 2d ago · AI intelligence enriched 3w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
PREFEST is an oral tablet combining estradiol and norgestimate indicated for moderate to severe vasomotor symptoms (hot flashes, night sweats) due to menopause. Estradiol is the principal intracellular estrogen that binds to nuclear receptors in estrogen-responsive tissues, while norgestimate provides progestin activity. The combination works by reducing elevated luteinizing hormone and FSH levels characteristic of postmenopausal women.
$0.157MPart D
LOE ApproachingDeclining
Declining spending and minimal Medicare claims signal a mature, contracted portfolio with reduced investment in growth initiatives.
Mechanism of Action
characteristics. Although circulating estrogens exist in a dynamic equilibrium of metabolic interconversions, estradiol is the principal intracellular human estrogen and is substantially more potent than its metabolites, estrone and estriol, at the receptor level. The primary source of estrogen in…
Indications (1)
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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.