ACTIVELLA
LOE ApproachingNDAORALTABLET
Approved
Apr 2000
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Data completeness
4/8 — Partial
ACTIVELLA by Novo Nordisk is characteristics. Approved for a woman with a uterus for: treatment of moderate to severe vasomotor symptoms due to menopause treatment of moderate to severe symptoms of vulvar, vaginal atrophy due to menopause limitations of use :, vaginal atrophy due to menopause and 1 more indications. First approved in 2000.
Drug data last refreshed 3h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ACTIVELLA is an oral estrogen/progestin combination tablet approved for treating moderate to severe vasomotor symptoms (hot flashes) and vulvar/vaginal atrophy in postmenopausal women with an intact uterus. It works by binding to estrogen and progesterone receptors to modulate hormone levels and reduce menopausal symptoms. The progestin component protects the uterus by opposing estrogen-driven endometrial proliferation.
$0.125MPart D
LOE ApproachingProduct approaching loss of exclusivity with modest Medicare utilization (~234 claims/year); brand team likely in defensive/transition mode with reduced headcount expectations.
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 (4)
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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.