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 3h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
PREFEST is an oral hormone replacement therapy combining estradiol and norgestimate for moderate to severe vasomotor symptoms associated with menopause. Estradiol is the principal intracellular human estrogen that binds to nuclear receptors in estrogen-responsive tissues to reduce elevated gonadotropin levels characteristic of postmenopause. The combination therapy provides cyclical estrogen-progestin replacement to manage hot flashes and related menopausal symptoms.
$0.157MPart D
LOE ApproachingLow spending volume and declining patient claims indicate product is in late-stage market maturity with limited growth opportunities and likely smaller commercial team.
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.