ACTIVELLA
LOE ApproachingNDAORALTABLET
Approved
Dec 2006
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 2006.
Drug data last refreshed 22h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ACTIVELLA is an oral tablet combining estradiol and norethindrone acetate indicated for moderate to severe vasomotor symptoms (hot flashes) and vulvar/vaginal atrophy in postmenopausal women with an intact uterus. The estrogen component binds to nuclear estrogen receptors to suppress elevated gonadotropins, while the progestin opposes estrogen effects to protect endometrial tissue. This combination approach addresses both menopausal symptoms and genitourinary syndrome in a single daily tablet.
$0.125MPart D
LOE ApproachingStable
Product is approaching loss of exclusivity with minimal current Part D spending ($125K in 2023), indicating a mature market with limited growth opportunities and likely smaller commercial support infrastructure.
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.